Federal Advisory Committees (FACs) are the single point of entry for the American public to provide consensus-based advice and recommendations to the federal government. These Advisory Committees are composed of experts from various fields who serve as Special Government Employees (SGEs), attending committee meetings, writing reports, and voting on potential government actions.

Advisory Committees are needed for the federal decision-making process because they provide additional expertise and in-depth knowledge for the Agency on complex topics, aid the government in gathering information from the public, and allow the public the opportunity to participate in meetings about the Agency’s activities. As currently organized, FACs are not equipped to provide the best evidence-based advice. This is because FACs do not meet transparency requirements set forth by GAO: making pertinent decisions during public meetings, reporting inaccurate cost data, providing  official meeting documents publicly available online, and more. FACs have also experienced difficulty with recruiting and retaining top talent to assist with decision making. For these reasons, it is critical that FACs are reformed and equipped with the necessary tools to continue providing the government with the best evidence-based advice. Specifically, advice as it relates to issues such as 1) decreasing the burden of hiring special government employees 2) simplifying the financial disclosure process 3) increasing understanding of reporting requirements and conflict of interest processes 4) expanding training for Advisory Committee members 5) broadening  the roles of Committee chairs and designated federal officials 6) increasing public awareness of Advisory Committee roles 7) engaging the public outside of official meetings 8) standardizing representation from Committee representatives 9) ensuring that Advisory Committees are meeting per their charters and 10) bolstering Agency budgets for critical Advisory Committee issues. 

Challenge and Opportunity

Protecting the health and safety of the American public and ensuring that the public has the opportunity to participate in the federal decision-making process is crucial. We must evaluate the operations and activities of federal agencies that require the government to solicit evidence-based advice and feedback from various experts through the use of federal Advisory Committees (FACs). These Committees are instrumental in facilitating transparent and collaborative deliberation between the federal government, the advisory body, and the American public and cannot be done through the use of any other mechanism. Advisory Committee recommendations are integral to strengthening public trust and reinforcing the credibility of federal agencies. Nonetheless, public trust in government has been waning and efforts should be made to increase public trust. Public trust is known as the pillar of democracy and fosters trust between parties, particularly when one party is external to the federal government. Therefore, the use of Advisory Committees, when appropriately used, can assist with increasing public trust and ensuring compliance with the law. 

There have also been many success stories demonstrating the benefits of Advisory Committees. When Advisory Committees are appropriately staffed based on their charge, they can decrease the workload of federal employees, assist with developing policies for some of our most challenging issues, involve the public in the decision-making process, and more. However, the state of Advisory Committees and the need for reform have been under question, and even more so as we transition to a new administration. Advisory Committees have contributed to the improvement in the quality of life for some Americans through scientific advice, as well as the monitoring of cybersecurity. For example, an FDA Advisory Committee reviewed data and saw promising results for the treatment of sickle cell disease (SCD) which has been a debilitating disease with limited treatment for years. The Committee voted in favor of gene therapy drugs Casgevy and Lyfgenia which were the first to be approved by the FDA for SCD. 

Under the first Trump administration, Executive Order (EO) 13875 resulted in a significant decrease in the number of federal advisory meetings. This  limited agencies’ ability to convene external advisors. Federal science advisory committees met less during this administration than any prior administration, met less than what was required from their charter, disbanded long standing Advisory Committees, and scientists receiving agency grants were barred from serving on Advisory Committees. Federal Advisory Committee membership also decreased by 14%, demonstrating the issue of recruiting and retaining top talent. The disbandment of Advisory Committees, exclusion of key scientific external experts from Advisory Committees, and burdensome procedures can potentially trigger  severe consequences that affect the health and safety of Americans. 

Going into a second Trump administration, it is imperative that Advisory Committees have the opportunity to assist federal agencies with the evidence-based advice needed to make critical decisions that affect the American public. The suggested reforms that follow can work to improve the overall operations of Advisory Committees while still providing the government with necessary evidence-based advice. With successful implementation of the following recommendations, the federal government will be able to reduce administrative burden on staff through the recruitment, onboarding, and conflict of interest processes. 

The U.S. Open Government Initiative encourages the promotion and participation of public and community engagement in  governmental affairs. However, individual Agencies can and should do more to engage the public. This policy memo identifies several areas of potential reform for Advisory Committees and aims to provide recommendations for improving the overall process without compromising Agency or Advisory Committee membership integrity. 

Plan of Action

The proposed plan of action identifies several policy recommendations to reform the federal Advisory Committee (Advisory Committee) process, improving both operations and efficiency. Successful implementation of these policies will  1) improve the Advisory Committee member experience, 2) increase transparency in federal government decision-making, and 3) bolster trust between the federal government, its Advisory Committees, and the public. 

Streamline Joining Advisory Committees

Recommendation 1. Decrease the burden of hiring special government employees in an effort to (1) reduce the administrative burden for the Agency and (2) encourage Advisory Committee members, who are also known as special government employees (SGEs), to continue providing the best evidence-based advice to the federal government through reduced onerous procedures

The Ethics in Government Act of 1978 and Executive Order 12674 lists OGE-450 reporting as the required public financial disclosure for all executive branch and special government employees. This Act provides the Office of Government Ethics (OGE) the authority to implement and regulate a financial disclosure system for executive branch and special government employees whose duties have “heightened risk of potential or actual conflicts of interest”. Nonetheless, the reporting process becomes onerous when Advisory Committee members have to complete the OGE-450 before every meeting even if their information remains unchanged. This presents a challenge for Advisory Committee members who wish to continue serving, but are burdened by time constraints. The process also burdens federal staff who manage the financial disclosure system. 

Policy Pathway 1. Increase funding for enhanced federal staffing capacity to undertake excessive administrative duties for financial reporting.

Policy Pathway 2. All federal agencies that deploy Advisory Committees can conduct a review of the current OGC-450 process, budget support for this process, and work to develop an electronic process that will eliminate the use of forms and allow participants to select dropdown options indicating if their financial interests have changed.  

Recommendation 2. Create and use public platforms such as OpenPayments by CMS to (1) aid in simplifying the financial disclosure reporting process and (2) increase transparency for disclosure procedures

Federal agencies should create a financial disclosure platform that streamlines the process and allows Advisory Committee members to submit their disclosures and easily make updates. This system should also be created to monitor and compare financial conflicts. In addition, agencies that utilize the expertise of Advisory Committees for drugs and devices should identify additional ways in which they can promote financial transparency. These agencies can use Open Payments, a system operated by Centers for Medicare & Medicaid Services (CMS), to “promote a more financially transparent and accountable healthcare system”. The Open Payments system makes payments from medical and drug device companies to individuals, healthcare providers, and teaching hospitals accessible to the public. If for any reason financial disclosure forms are called into question, the Open Payments platform can act as a check and balance in identifying any potential financial interests of Advisory Committee members. Further steps that can be taken to simplify the financial disclosure process would be to utilize conflict of interest software such as Ethico which is a comprehensive tool that allows for customizable disclosure forms, disclosure analytics for comparisons, and process automation.   

Policy Pathway. The Office of Government Ethics should require all federal agencies that operate Advisory Committees to develop their own financial disclosure system and include a second step in the financial disclosure reporting process as due diligence, which includes reviewing the Open Payments by CMS system for potential financial conflicts or deploying conflict of interest monitoring software to streamline the process.

Streamline Participation in an Advisory Committee

Recommendation 3. Increase understanding of annual reporting requirements for conflict of interest (COI)

Agencies should develop guidance that explicitly states the roles of Ethics Officers, also known as Designated Agency Ethics Officials (DAEO), within the federal government. Understanding the roles and responsibilities of Advisory Committee members and the public will help reduce the spread of misinformation regarding the purpose of Advisory Committees. In addition, agencies should be encouraged by the Office of Government Ethics to develop guidance that indicates the criteria for inclusion or exclusion of participation in Committee meetings. Currently, there is no public guidance that states what types of conflicts of interests are granted waivers for participation. Full disclosure of selection and approval criteria will improve transparency with the public and draw clear delineations between how Agencies determine who is eligible to participate. 

Policy Pathway. Develop conflict of interest (COI) and financial disclosure guidance specifically for SGEs that states under what circumstances SGEs are allowed to receive waivers for participation in Advisory Committee meetings.

Recommendation 4. Expand training for Advisory Committee members to include (1) ethics and (2) criteria for making good recommendations to policymakers

Training should be expanded for all federal Advisory Committee members to include ethics training which details the role of Designated Agency Ethics Officials, rules and regulations for financial interest disclosures, and criteria for making evidence-based recommendations to policymakers. Training for incoming Advisory Committee members ensures that all members have the same knowledge base and can effectively contribute to the evidence-based recommendations process.

Policy Pathway. Agencies should collaborate with the OGE and Agency Heads to develop comprehensive training programs for all incoming Advisory Committee members to ensure an understanding of ethics as contributing members, best practices for providing evidence-based recommendations, and other pertinent areas that are deemed essential to the Advisory Committee process.

Leverage Advisory Committee Membership

Recommendation 5. Uplifting roles of the Committee Chairs and Designated Federal Officials

Expanding the roles of Committee Chairs and Designated Federal Officers (DFOs) may assist federal Agencies with recruiting and retaining top talent and maximizing the Committee’s ability to stay abreast of critical public concerns. Considering the fact that the General Services Administration has to be consulted for the formation of new Committees, renewal, or alteration of Committees, they can be instrumental in this change.

Policy Pathway. The General Services Administration (GSA) should encourage federal Agencies to collaborate with Committee Chairs and DFOs to recruit permanent and ad hoc Committee members who may have broad network reach and community ties that will bolster trust amongst Committees and the public. 

Recommendation 6. Clarify intended roles for Advisory Committee members and the public

There are misconceptions among the public and Advisory Committee members about Advisory Committee roles and responsibilities. There is also ambiguity regarding the types of Advisory Committee roles such as ad hoc members, consulting, providing feedback for policies, or making recommendations. 

Policy Pathway. GSA should encourage federal Agencies to develop guidance that delineates the differences between permanent and temporary Advisory Committee members, as well as their roles and responsibilities depending on if they’re providing feedback for policies or providing recommendations for policy decision-making.

Recommendation 7. Utilize and engage expertise and the public outside of public meetings

In an effort to continue receiving the best evidence-based advice, federal Agencies should develop alternate ways to receive advice outside of public Committee meetings. Allowing additional opportunities for engagement and feedback from Committee experts or the public will allow Agencies to expand their knowledge base and gather information from communities who their decisions will affect.

Policy Pathway. The General Services Administration should encourage federal Agencies to create opportunities outside of scheduled Advisory Committee meetings to engage Committee members and the public on areas of concern and interest as one form of engagement. 

Recommendation 8. Standardize representation from Committee representatives (i.e., industry), as well as representation limits

The Federal Advisory Committee Act (FACA) does not specify the types of expertise that should be represented on all federal Advisory Committees, but allows for many types of expertise. Incorporating various sets of expertise that are representative of the American public will ensure the government is receiving the most accurate, innovative, and evidence-based recommendations for issues and products that affect Americans. 

Policy Pathway. Congress should include standardized language in the FACA that states all federal Advisory Committees should include various sets of expertise depending on their charge. This change should then be enforced by the GSA.

Support a Vibrant and Functioning Advisory Committee System

Recommendation 9. Decrease the burden to creating an Advisory Committee and make sure Advisory Committees are meeting per their charters

The process to establish an Advisory Committee should be simplified in an effort to curtail the amount of onerous processes that lead to a delay in the government receiving evidence based advice.

Advisory Committee charters state the purpose of Advisory Committees, their duties, and all aspirational aspects. These charters are developed by agency staff or DFOs with consultation from their agency Committee Management Office. Charters are needed to forge the path for all FACs.

Policy Pathway. Designated Federal Officers (DFOs) within federal agencies should work with their Agency head to review and modify steps to establishing FACs. Eliminate the requirement for FACs to require consultation and/or approval from GSA for the formation, renewal, or alteration of Advisory Committees.

Recommendation 10. Bolster agency budgets to support FACs on critical issues where regular engagement and trust building with the public is essential for good policy

Federal Advisory Committees are an essential component to receive evidence-based recommendations that will help guide decisions at all stages of the policy process. These Advisory Committees are oftentimes the single entry point external experts and the public have to comment and participate in the decision-making process. However, FACs take considerable resources to operate depending on the frequency of meetings, the number of Advisory Committee members, and supporting FDA staff. Without proper appropriations, they have a diminished ability to recruit and retain top talent for Advisory Committees. The Government Accountability Office (GAO) reported that in 2019, approximately $373 million dollars was spent to operate a total of 960 federal Advisory Committees. Some Agencies have experienced a decrease in the number of Advisory Committee convenings. Individual Agency heads should conduct a budget review of average operating and projected costs and develop proposals for increased funding to submit to the Appropriations Committee.  

Policy Pathway. Congress should consider increasing appropriations to support FACs so they can continue to enhance federal decision-making, improve public policy, boost public credibility, and Agency morale. 

Conclusion

Advisory Committees are necessary to the federal evidence-based decision-making ecosystem. Enlisting the advice and recommendations of experts, while also including input from the American public, allows the government to continue making decisions that will truly benefit its constituents. Nonetheless, there are areas of FACs that can be improved to ensure it continues to be a participatory, evidence-based process. Additional funding is needed to compensate the appropriate Agency staff for Committee support, provide potential incentives for experts who are volunteering their time, and finance other expenditures.

Frequently Asked Questions

How will Federal Advisory Committees (Advisory Committees) increase government efficiency?

With reform of Advisory Committees, the process for receiving evidence-based advice will be streamlined, allowing the government to receive this advice in a faster and less burdensome manner. Reform will be implemented by reducing the administrative burden for federal employees through the streamlining of recruitment, financial disclosure, and reporting processes.

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The health and wellbeing of American babies have been put at risk in recent years, and we can do better. Recent events have revealed deep vulnerabilities in our nation’s infant nutritional security. For example: Pandemic-induced disruptions in maternity care practices that support  the establishment of breastfeeding; the infant formula recall and resulting shortage; and a spate of weather-related natural disasters have demonstrated infrastructure gaps and a lack of resilience to safety and supply chain challenges. All put babies in danger during times of crisis.

Breastfeeding is foundational to lifelong health and wellness, but systemic barriers prevent many families from meeting their breastfeeding goals. The policies and infrastructure surrounding postpartum families often limit their ability to succeed in breastfeeding. Despite important benefits, new data from the CDC shows that while 84.1% of infants start out breastfeeding, these numbers fall dramatically in the weeks after birth, with only 57.5% of infants breastfeeding exclusively at one month of age. Disparities persist across geographic location, and other sociodemographic factors, including race/ethnicity, maternal age, and education. Breastfeeding rates in North America are the lowest in the world. Longstanding evidence shows that it is not a lack of desire but rather a lack of support, access, and resources that creates these barriers.

This administration has an opportunity to take a systems approach to increasing support for breastfeeding and making parenting easier for new mothers. Key policy changes to address systemic barriers include providing guidance to states on expanding Medicaid coverage of donor milk, building breastfeeding support and protection into the existing emergency response framework at the Federal Emergency Management Agency, and expressing support for establishing a national paid leave program. 

Policymakers on both sides of the aisle agree that no baby should ever go hungry, as evidenced by the bipartisan passage of recent breastfeeding legislation (detailed below) and widely supported regulations. However, significant barriers remain. This administration has the power to address long-standing inequities and set the stage for the next generation of parents and infants to thrive. Ensuring that every family has the support they need to make the best decisions for their child’s health and wellness benefits the individual, the family, the community, and the economy. 

Challenge and Opportunity

Breastfeeding plays an essential role in establishing good nutrition and healthy weight, reducing the risk of chronic disease and infant mortality, and improving maternal and infant health outcomes. Breastfed children have a decreased risk of obesity, type 1 and 2 diabetes, asthma, and childhood leukemia. Women who breastfeed reduce their risk of specific chronic diseases, including type 2 diabetes, cardiovascular disease, and breast and ovarian cancers. On a relational level, the hormones produced while breastfeeding, like oxytocin, enhance the maternal-infant bond and emotional well-being. The American Academy of Pediatrics recommends infants be exclusively breastfed for approximately six months with continued breastfeeding while introducing complementary foods for two years or as long as mutually desired by the mother and child.  

Despite the well-documented health benefits of breastfeeding, deep inequities in healthcare, community, and employment settings impede success. Systemic barriers disproportionately impact Black, Indigenous, and other communities of color, as well as families in rural and economically distressed areas. These populations already bear the weight of numerous health inequities, including limited access to nutritious foods and higher rates of chronic disease—issues that breastfeeding could help mitigate. 

Breastfeeding Saves Dollars and Makes Sense 

Low breastfeeding rates in the United States cost our nation millions of dollars through higher health system costs, lost productivity, and higher household expenditures. Not breastfeeding is associated with economic losses of about $302 billion annually or 0.49% of world gross national income. At the national level, improving breastfeeding practices through programs and policies is one of the best investments a country can make, as every dollar invested is estimated to result in a $35 economic return. 

In the United States, chronic disease management results in trillions of dollars in annual healthcare costs, which increased breastfeeding rates could help reduce. In the workplace setting, employers see significant cost savings when their workers are able to maintain breastfeeding after returning to work. Increased breastfeeding rates are also associated with reduced environmental impact and associated expenses. Savings can be seen at home as well, as following optimal breastfeeding practices reduces household expenditures. Investments in infant nutrition last a lifetime, paying long-term dividends critical for economic and human development. Economists have completed cost-benefit analyses, finding that investments in nutrition are one of the best value-for-money development actions, laying the groundwork for the success of investments in other sectors.

Source: Centers for Disease Control and Prevention, National Immunization Survey – Child (NIS-Child), Breastfeeding Results

Breastfeeding Initiation Rates and Maps by County

Source: Centers for Disease Control and Prevention National Vital Statistics System US Birth Certificate Breastfeeding Initiation Data, 2018–2019

Ongoing trends in breastfeeding outcomes indicate that there are entrenched policy-level challenges and barriers that need to be addressed to ensure that all infants have an opportunity to benefit from access to human milk. Currently, for too many families, the odds are stacked against them. It’s not a question of individual choice but one of systemic injustice. Families are often forced into feeding decisions that do not reflect their true desires due to a lack of accessible resources, support, and infrastructure.

While the current landscape is rife with challenges, the solutions are known and the potential benefits are tremendous. This administration has the opportunity to realize these benefits and implement a smart and strategic response to the urgent situation that our nation is facing just as the political will is at an all-time high. 

The History of Breastfeeding Policy

In the late 1960s and early 1970s less than 30 percent of infants were breastfed. The concerted efforts of individuals and organizations and the emergence of the field of lactation have worked to counteract or remove many barriers, and policymakers have sent a clear and consistent message that breastfeeding is bipartisan. This is evident in the range of recent lactation-friendly legislation, including: 

• Bottles and Breastfeeding Equipment Screening Act (BABES Act) in 2016 
• Friendly Airports for Mothers (FAM) Act in 2018 
• Fairness for Breastfeeding Mothers Act in 2019
• Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act in 2022 

Administrative efforts ranging from the Business Case for Breastfeeding to The Surgeon General’s Call to Action to Support Breastfeeding and the armed services updates on uniform requirements for lactating soldiers demonstrate a clear commitment to breastfeeding support across the decades. 

These policy changes have made a difference. But additional attention and investment, with a particular focus on the birth and early postpartum period, as well as during and after emergencies, is needed to secure the potential health and economic benefits of comprehensive societal support for breastfeeding. This administration can take considerable steps toward improving  U.S. health and wellness and protecting infant nutrition security.  

Plan of Action

A range of federal agencies coordinate programs, services, and initiatives impacting the breastfeeding journey for new parents. Expanding and building on existing efforts through the following steps can help address some of today’s most pressing barriers to breastfeeding. 

Each of the recommended actions can be implemented independently and would create meaningful, incremental change for families. However, a comprehensive approach that implements all these recommendations would create the marked shift in the landscape needed to improve breastfeeding initiation and duration rates and establish this administration as a champion for breastfeeding families. 

Agency	Agency Role	Recommend Action	Anticipated Outcome
Federal Emergency Management Agency (FEMA)	FEMA coordinates within the federal government to make sure America is equipped to prepare for and respond to disasters.	Require FEMA to participate in the Federal Interagency Breastfeeding Workgroup, a collection of federal agencies that come together to connect and collaborate on breastfeeding issues.	Increased connection and coordination across agencies.
Federal Emergency Management Agency (FEMA)	FEMA coordinates within the federal government to make sure America is equipped to prepare for and respond to disasters.	Update the FEMA Public Assistance Program and Policy Guide to include breastfeeding and lactation as a functional need so that emergency response efforts can include services from lactation support providers.	Integration of breastfeeding support into emergency response and recovery efforts.
Office of Management & Budget (OMB)	The OMB oversees the implementation of the President’s vision across the Executive Branch, including through budget development and execution.	Include funding for the establishment of a national paid family and medical leave program as a priority in the President’s Budget.	Setting the stage for Congressional action.
Domestic Policy Council (DPC)	The DPC drives the development and implementation of the President’s domestic policy agenda in the White House and across the Federal government.	Support the efforts of the bipartisan, bicameral congressional Paid Leave Working Group.	Setting the stage for Congressional action.

This table summarizes the recommendations, grouped by the federal agency that would be responsible for implementing the change to increase breastfeeding rates in the U.S. for improved health and economic outcomes.

Recommendation 1. Increase access to pasteurized donor human milk by directing the Centers for Medicare & Medicaid Services (CMS) to provide guidance to states on expanding Medicaid coverage. 

Pasteurized donor human milk is lifesaving for vulnerable infants, particularly those born preterm or with serious health complications. Across the United States, milk banks gently pasteurize donated human milk and distribute it to fragile infants in need. This lifesaving liquid gold reduces mortality rates, lowers healthcare costs, and shortens hospital stays. Specifically, the use of donor milk is associated with increased survival rates and lowered rates of infections, sepsis, serious lung disease, and gastrointestinal complications. In 2022, there were 380,548 preterm births in the United States, representing 10.4% of live births, so the potential for health and cost savings is substantial. Data from one study shows that the cost of a neonatal intensive care unit stay for infants at very low birth weight is nearly $220,000 for 56 days. The use of donor human milk can reduce hospital length of stay by 18-50 days by preventing the development of necrotizing enterocolitis in preterm infants. The benefits of human milk extend beyond the inpatient stay, with infants receiving all human milk diets in the NICU experiencing fewer hospital readmissions and better overall long-term outcomes.

Although donor milk has important health implications for vulnerable infants in all communities and can result in significant economic benefit, donor milk is not equitably accessible. While milk banks serve all states, not all communities have easy access to donated human milk. Moreover, many insurers are not required to cover the cost, creating significant barriers to access and contributing to racial and geographic disparities.

To ensure that more babies in need have access to lifesaving donor milk, the administration should work with CMS to expand donor milk coverage under state Medicaid programs. Medicaid covers approximately 40% of all US births and 50% of all early preterm births. Medicaid programs in at least 17 states and the District of Columbia already include coverage of donor milk. The administration can expand access to this precious milk, help reduce health care costs, and address racial and geographic disparities by releasing guidance for the remaining states regarding coverage options in Medicaid.

Recommendation 2. Include infant feeding in Federal Emergency Management Agency (FEMA) emergency planning and response.

Infants and children are among the most vulnerable in an emergency, so it is critical that their unique needs are considered and included in emergency planning and response guidance. Breastfeeding provides clean, optimal nutrition, requires no fuel, water, or electricity, and is available, even in the direst circumstances. Human milk contains antibodies that fight infection, including diarrhea and respiratory infections common among infants in emergency situations. Yet efforts to protect infant and young child feeding in emergencies are sorely lacking, particularly in the immediate aftermath of disasters and emergencies. 

Ensuring access to lactation support and supplies as part of emergency response efforts is essential for protecting the health and safety of infants. Active support and coordination between federal, state, and local governments, the commercial milk formula industry, lactation support providers, and all other relevant actors involved in response to emergencies is needed to ensure safe infant and young child feeding practices and equitable access to support. There are two simple, cost-effective steps that FEMA can take to protect breastfeeding, preserve resources, and thus save additional lives during emergencies.

• Require FEMA to participate in the Federal Interagency Breastfeeding Workgroup, a collection of federal agencies that come together to connect and collaborate on breastfeeding issues, to ensure coordination across agencies.
  
• Update the FEMA Public Assistance Program and Policy Guide (PAPPG) to include breastfeeding and lactation as a functional need in the section on Congregate Shelter Services so that emergency response efforts can include services from lactation support providers and be reimbursed for the associated costs. 

Recommendation 3. Expand access to paid family & medical leave by including paid leave as a priority in the President’s Budget and supporting the efforts of the bipartisan, bicameral congressional Paid Leave Working Group. 

Employment policies in the United States make breastfeeding harder than it needs to be. The United States is one of the only countries in the world without a national paid family and medical leave program. Many parents return to work quickly after birth, before a strong breastfeeding relationship is established, because they cannot afford to take unpaid leave or because they do not qualify for paid leave programs with their employer or through state or local programs. Nearly 1 in 4 employed mothers return to work within two weeks of childbirth.

Paid family leave programs make it possible for employees to take time for childbirth recovery, bond with their baby, establish feeding routines, and adjust to life with a new child without threatening their family’s economic well-being. This precious time provides the foundation for success, contributing to improved rates of breastfeeding initiation and duration, yet only a small portion of workers are able to access it. There are significant disparities in access to paid leave among racial and ethnic groups, with Black and Hispanic employees less likely than their white non-Hispanic counterparts to have access to paid parental leave. There are similar disparities in breastfeeding outcomes among racial groups.  

The momentum is building substantially to improve the paid family and medical leave landscape in the United States. Thirteen states and the District of Columbia have established mandatory state paid family leave systems. Supporting paid leave has become an important component of candidate campaign plans, and bipartisan support for establishing a national program remains strong among voters. The formation of Bipartisan Paid Family Leave Working Groups in both the House and Senate demonstrate commitment from policymakers on both sides of the aisle. 

By directing the Office of Management and Budget to include funding for paid leave in the President’s Budget recommendation and working collaboratively with the Congressional Paid Leave Working Groups, the administration can advance federal efforts to increase access to paid family and medical leave, improving public health and helping American businesses.  

Conclusion

These three strategies offer the opportunity for the White House to make an immediate and lasting impact by protecting infant nutrition security and addressing disparities in breastfeeding rates, on day one of the Presidential term. A systems approach that utilizes multiple strategies for integrating breastfeeding into existing programs and efforts would help shift the paradigm for new families by addressing long-standing barriers that disproportionately affect marginalized communities—particularly Black, Indigenous, and families of color. A clear and concerted effort from the Administration, as outlined, offers the opportunity to benefit all families and future generations of American babies. 

The administration’s focused and strategic efforts will create a healthier, more supportive world for babies, families, and breastfeeding parents, improve maternal and child health outcomes, and strengthen the economy. This administration has the chance to positively shape the future for generations of American families, ensuring that every baby gets the best possible start in life and that every parent feels empowered and supported.

Now is the time to build on recent momentum and create a world where families have true autonomy in infant feeding decisions. A world where paid family leave allows parents the time to heal, bond, and establish feeding routines; communities provide equitable access to donor milk; and federal, state, and local agencies have formal plans to protect infant feeding during emergencies, ensuring no baby is left vulnerable. Every family deserves to feel empowered and supported in making the best choices for their children, with equitable access to resources and support systems.

This policy memo was written with support from Suzan Ajlouni, Public Health Writing Specialist at the U.S. Breastfeeding Committee. The policy recommendations have been identified through the collective learning, idea sharing, and expertise of USBC members and partners.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

Isn’t the choice to breastfeed a personal one?

Rather than being a matter of personal choice, infant feeding practice is informed by circumstance and level (or lack) of support. When roadblocks exist at every turn, families are backed into a decision because the alternatives are not available, attainable, or viable. United States policies and infrastructure were not built with the realities of breastfeeding in mind. Change is needed to ensure that all who choose to breastfeed are able to meet their personal breastfeeding goals, and society at large reaps the beneficial social and economic outcomes.

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How much would it cost to establish a national paid family and medical leave program?

The Fiscal Year 2024 President’s Budget proposed to establish a national, comprehensive paid family and medical leave program, providing up to 12 weeks of leave to allow eligible workers to take time off to care for and bond with a new child; care for a seriously ill loved one; heal from their own serious illness; address circumstances arising from a loved one’s military deployment; or find safety from domestic violence, sexual assault, or stalking. The budget recommendation included $325 billion for this program. It’s important to look at this with the return on investment in mind, including improved labor force attachment and increased earnings for women; better outcomes and reduced health care costs for ill, injured, or disabled loved ones; savings to other tax-funded programs, including Medicaid, SNAP, and other forms of public assistance; and national economic growth, jobs growth, and increased economic activity.

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How will we know if these efforts are having an impact?

There are a variety of national monitoring and surveillance efforts tracking breastfeeding initiation, duration, and exclusivity rates that will inform how well these actions are working for the American people, including the National Immunization Survey (NIS), Pregnancy Risk Assessment and Monitoring System (PRAMS), Infant Feeding Practices Study, and National Vital Statistics System. The CDC Breastfeeding Report card is published biannually to bring these key data points together and place them into context. Significant improvements in the data have already been seen across recent decades, with breastfeeding initiation rates increasing from 73.1 percent in 2004 to 84.1 percent in 2021.

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Is there enough buy-in from organizations and individuals to support these systemic changes?

The U.S. Breastfeeding Committee is a coalition bringing together approximately 140 organizations from coast to coast representing the grassroots to the treetops – including federal agencies, national, state, tribal, and territorial organizations, and for-profit businesses – that support the USBC mission to create a landscape of breastfeeding support across the United States. Nationwide, a network of hundreds of thousands of grassroots advocates from across the political spectrum support efforts like these. Together, we are committed to ensuring that all families in the U.S. have the support, resources, and accommodations to achieve their breastfeeding goals in the communities where they live, learn, work, and play. The U.S. Breastfeeding Committee and our network stand ready to work with the administration to advance this plan of action.

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The U.S. healthcare system produces 5 million tons of waste annually, or approximately 29 pounds per hospital bed daily. Roughly 80 percent of the healthcare industry’s carbon footprint comes from the production, transportation, use, and disposal of single-use devices (SUDs), which are pervasive in the hospital. Notably, 95% of the environmental impact of single-use medical products results from the production of those products. 

While the Food and Drug Administration (FDA) oversees new devices being brought to market, it is up to the manufacturer to determine whether a device will be marketed as single-use or multiple-use. Manufacturers have a financial incentive to market devices for “single-use” or “disposable” as marketing a device as reusable requires expensive cleaning validations.

In order to decrease healthcare waste and environmental impact, FDA leads on identifying reusable devices that can be safely reprocessed and incentivizing manufacturers to test the reprocessing of their device. This will require the FDA to strengthen its management of single-use and reusable device labeling. Further, the Veterans Health Administration, the nation’s largest healthcare system, should reverse the prohibition on reprocessed SUDs and become a national leader in the reprocessing of medical devices.

Challenge and Opportunity

While healthcare institutions are embracing decarbonization and waste reduction plans, they cannot do this effectively without addressing the enormous impact of single-use devices (SUDs). The majority of research literature concludes that SUDs are associated with higher levels of environmental impact than reusable products. 

FDA regulations governing SUD reprocessing make it extremely challenging for hospitals to reprocess low-risk SUDs, which is inconsistent with the FDA’s “least burdensome provisions.” The FDA requires hospitals or commercial SUD reprocessing facilities to act as the device’s manufacturer, meaning they must follow the FDA’s rules for medical device manufacturers’ requirements and take on the associated liabilities. Hospitals are not keen to take on the liability of a manufacturer, yet commercial reprocessors do not offer many lower-risk devices that can be reprocessed. 

As a result, hospitals and clinics are no longer willing to sterilize SUDs through methods like autoclaving even despite documentation showing that sterilization is safe and precedent showing that similar devices have been safely sterilized and reused for many years without adverse events. Many devices, including pessaries for pelvic organ prolapse and titanium phacoemulsification tips for cataract surgery, can be safely reprocessed in their clinical use. These products, given their risk profile, need not be subject to the FDA’s full medical device manufacturer requirements.  

Further, manufacturers are incentivized to bring SUDs to market quicker than those that may be reprocessed. Manufacturers often market devices as single-use solely because the original manufacturer chose not to conduct expensive cleaning and sterilization validations, not because such cleaning and sterilization validations cannot be done. FDA regulations that govern SUDs should be better tailored to each device so that clinicians on the frontlines can provide appropriate and environmentally sustainable health care. 

Reprocessed devices cost 25 to 40% less. Thus, the use of reprocessed SUDs can reduce costs in hospitals significantly — about $465 million in 2023. Per the Association of Medical Device Reprocessors, if the reprocessing practices of the top 10% performing hospitals were maximized across all hospitals that use reprocessed devices, U.S. hospitals could have saved an additional $2.28 billion that same year. Indeed, enabling and encouraging the use of reprocessed SUDs can also yield significant cost reductions without compromising patient care. 

Plan of Action

As the FDA began regulating SUD reprocessing in 2000, it is imperative that the FDA take the lead on creating a clear, streamlined process for clearing or approving reusable devices in order to ensure the safety and efficacy of reprocessed devices. These recommendations would permit healthcare systems to reprocess and reuse medical devices without fear of noncompliance by the Joint Commission or Centers for Medicare and Medicaid Services that reply on FDA regulations. Further, the nation’s largest healthcare system, the Veterans Health Administration, should become a leader in medical device reprocessing, and lead on showcasing the standard of practice for sustainable healthcare.

1. FDA should publish a list of SUDs that have a proven track record of safe reprocessing to empower hospitals to reduce waste, costs, and environmental impact without compromising patient safety. The FDA should change the labels of single-use devices to multi-use when reuse by hospitals is possible and validated via clinical studies, as the “single-use” label has promoted the mistaken belief that SUDs cannot be safely reprocessed. Per the FDA, the single-use label simply means a given device has not undergone the original equipment manufacturer (OEM) validation tests necessary to label a device “reusable.” The label does not mean the device cannot be cleared for reprocessing. 

2. In order to help governments and healthcare systems prioritize the environmental and cost benefits of reusable devices over SUDs, FDA should incentivize applications of reusable or commercially reprocessable devices, such as through expediting review. The FDA can also incentivize use of reprocessed devices through payments to hospitals for meeting reprocessing benchmarks. 

3. The FDA should not subject low-risk devices that can be safely reprocessed for clinical use to full device manufacturer requirements. The FDA should further encourage healthcare procurement staff by creating an accessible database of devices cleared for reprocessing and alerting healthcare systems about regulated reprocessing options. In doing so, the FDA can help reduce the burden on hospitals in reprocessing low-risk SUDs and encourage healthcare systems to sterilize SUDs through methods like autoclaving. 

4. As the only major health system in the U.S. to prohibit the use of reprocessed SUDs, the U.S. Veterans Health Administration should reverse its prohibition as soon as possible. This prohibition likely remains because of outdated determinations of risks, which comes at major costs for the environment and Americans. Doing so would be consistent with the FDA’s conclusions that reprocessed SUDs are safe and effective.  

5. FDA should recommend that manufacturers publicly report the materials used in the composition of devices so that end-users can more easily compare products and determine the environmental impact of devices. As explained by AMDR, some Original Equipment Manufacturer (OEM) practices discourage or fully prevent the use of reprocessed devices. It is imperative that the FDA vigorously track and impede these practices. Not only will requiring public reporting device composition help healthcare buyers make more informed decisions, it will also help promote a more circular economy that uplifts sustainability efforts. 

Conclusion

To decrease costs, waste, and environmental impact, the healthcare sector urgently needs to increase its use of reusable devices. One of the largest barriers is FDA requirements that result in needlessly stringent requirements of hospitals, hindering the adoption of less wasteful, less costly reprocessed devices.

FDA’s critical role in medical device labeling, clearing, or approving more devices as reusable, has down market implications and influences many other regulatory and oversight bodies, including the Centers for Medicare & Medicaid Services (CMS), the Association for the Advancement of Medical Instrumentation (AAMI), the Joint Commission, hospitals, health care offices, and health care providers. It is essential for the FDA to step up and take the lead in revising the device reprocessing pipeline. 

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

A peer support option should be integrated into the 988 Suicide and Crisis Lifeline so that 988 service users can choose to connect with specialists based on a shared lived experience. As people and communities become more siloed, the risk of mortality and morbidity increases. Social connectedness is a critical protective factor. A peer support service would allow individuals to receive support built on a lived experience that is common to both the service user and the specialist. It should be free and easily accessible through phone call and text messaging. This service is especially timely, following the 2020 rollout of the 988 Suicide and Crisis Lifeline, as well as recent peer support initiatives at the federal and state levels.

While the efficacy of peer support is most known with mental illness, it has successfully helped a range of individuals including cancer patients, people experiencing homelessness, racial minorities, veterans, and formerly incarcerated people. The peer support service should provide support for all kinds of lived experience, including experiences with: disability resulting from poor physical or mental health, substance use, suicidal ideation, veteran-connected disability, financial insecurity, homelessness, domestic violence and family court, nonnuclear family structures or living alone, former incarceration, and belonging to racial or ethnic minority groups. The service should be a preventative intervention as well as complimentary assistance for those in recovery or treatment.

Challenge and Opportunity

The United States faces an “epidemic of loneliness and isolation.” While individuals from all backgrounds are afflicted, the most vulnerable and underserved members of society have suffered the most. A range of challenging circumstances cause this suffering, including poor physical or mental health, nontraditional living conditions, and historic inequality. Not having anyone who shares one’s lived experience is isolating. These challenging life circumstances take an emotional toll, and they become risk factors for a slew of physical and mental health conditions that increase morbidity and decrease life expectancy. 

In addition to the social costs, these outcomes have an increasingly devastating economic impact. Health care costs are projected to account for 20% of the U.S. economy by 2031. Psychiatric hospitalizations are steadily increasing, and a shortage of psychiatric inpatient beds is rampant.

Social connectedness alleviates physical and mental burdens. Peer support offers a cost-effective intervention for prevention and recovery. It reduces spending on both physical and mental illnesses, and it reduces psychiatric hospitalizations, saving an average of $4.76 for every $1 spent on peer support. In a New York City-based peer support program, service users saved about $2,000 per month in Medicaid costs and had 2.9 fewer hospitalizations per year. 

Telephone-based peer support has life-saving outcomes, too. Over telephone, peer support led to a 15% increase in women’s mammography screening rates, with the highest increase among women of low-to-middle income. Telephone-based peer support increased breastfeeding rates by 14% and reduced breastfeeding dissatisfaction by 10% among first-time mothers, and it led to a 10% change in diet among patients with heart disease. While peer support would not solve national crises of homelessness or rising healthcare costs, it would ease them by fostering community empowerment and self-reliance and reducing federal intervention.

In 2023, SAMHSA rolled out “National Model Standards for Peer Support Certification”. This guide provides recommendations for how each state can integrate its own “peer mental health workforce across all elements of the healthcare system.” In its current form, SAMHSA’s strategy targets lived experiences with substance use and mental health. A broader scope would assist and empower more underserved members of the community. Following the momentum of SAMHSA’s initiative, now is the most optimal time to integrate a peer support service into the 988 Lifeline.

Peer support exists in the U.S., but services are spread thin across private and nonprofit sectors. The Restoring Hope for Mental Health and Well-Being Act of 2022 authorized $1.7 trillion in funding until FY2027 for various health initiatives, including peer support mental health services. This funding relies on organizations and institutions to independently implement peer support services based on community needs. However, a fragmented system can result in underuse, limited accessibility, and a varied quality of service, with pockets of the United States lacking any service at all. It also poses privacy concerns about how individuals’ data are stored and used, as well as cybersecurity vulnerabilities with smaller organizations that may lack a robust security infrastructure.

A peer support service that is integrated into the 988 Lifeline would ensure that all Americans have equal access to a high-quality, confidential peer support network. The standardization of the 988 Lifeline is a prime example of successful implementation. Its transition from a 10-digit number to a three-digit dial led to a 33% average increase in in-state call volume over four months. Standardization shifted funding from primarily private and nonprofit initiatives and donations to stable public sector support. As a result, call pickup rates rose from 70% to 93%, and wait times dropped from 2 minutes 20 seconds to just 35 seconds.

The 988 Lifeline also adheres to privacy and confidentiality protocols in line with the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. Under these protocols, the 988 Lifeline retains minimal information about callers and texters, and this information stays private and securely stored. A peer support service with similar safeguards would help both service users and peer support workers (PSWs) feel safe when sharing sensitive information.

Peer support for mental health has gained traction recently. The National Alliance for Mental Illness (NAMI) offers peer-to-peer courses, although these are currently limited in their duration and available locations. Last year, Congress expressed an interest in peer support mental health services: a “Supporting All Students Act” was proposed in the Senate for “peer and school-based mental health support.” This endeavor especially targets the escalating suicide crisis among youths in the form of a peer-to-peer suicide prevention. The Wisconsin Department of Public Instruction also recently introduced Peer-to-Peer Suicide Prevention Grants. The federal and state-level governments clearly recognize the value of peer support work. Still, they underutilize its potential.

Loneliness and isolation are at an all-time high in the United States. However, they stem from a multitude of causes. An empathic connection with a peer who has lived the same experience has immense potential for healing and recovery in both the PSW and the service user. The 988 Lifeline should include an integrated peer support service for both mental health and a broad range of lived experiences. While there exist some peer support services for conditions not related to mental health, these are not standardized or easily accessible to the entire American population. Many peer-operated warmlines (i.e., support lines) exist. However, they are spread across dozens of phone numbers and websites with varied and limited sources of funding. A single peer support service integrated into the 988 Lifeline would make peer support universally available. This service would address the emotional toll that accompanies a wide range of challenging life circumstances.

In short, a peer support service integrated into the 988 Lifeline would make the efforts of existing peer support organizations even more effective as it would:

• Standardize training, quality of care, and confidentiality,
• Expand the kinds of lived experience that are available for peer support, and
• Maximize the distribution of high-quality services across the U.S., with a focus on reaching high-risk populations.

Action Plan

The peer support service should begin by covering only a few kinds of lived experiences. After this implementation, the service should be expanded to cover a broader range of experiences.

Recommendation 1. Create a Peer Support Task Force (PSTF).

A PSTF should be established within SAMHSA. The secretary of the U.S. Department of Health and Human Services (HHS) should work with SAMHSA’s assistant secretary for mental health and substance use to establish this temporary task force.

The PSTF should lead the implementation of the peer support service, acting as an interagency task force that coordinates with partners across the public, private, and nonprofit sectors. This partnership will ensure that different lived experiences are accounted for and that existing resources are used effectively. The PSTF should collaborate with federal agencies, including the Department of Veterans Affairs (VA) and the Indian Health Service (IHS), as well as with advocacy organizations like NAMI and the American Cancer Society that champion the needs of people with specific lived experiences.

The PSTF should be charged with the following recommendations to start.

Recommendation 2. Integrate a peer support option into the 988 Lifeline.

Under the authority of the PSTF, integrating a peer support option into the 988 Lifeline could bypass additional Congressional action.

In the first pass, the integrated peer support option should cover only a few kinds of lived experiences (e.g., suicide and behavioral crises, veteran-connected disability).

1. Before scaling the peer support service across the United States, the PSTF should implement a pilot program to test and refine protocols. The PSTF should select 988 Lifeline centers in states that already have a strong peer support program, and it should pilot peer support call and text services. The pilot program should select a few peer support needs to test first (e.g., suicide and behavioral crises, veteran-connected disability), as a narrow scope will be easier to assess for the first pass.
2. The PSTF should then incorporate feedback from this pilot program as it scales up and integrates a peer support option into the nationwide 988 Lifeline.
3. The PSTF should coordinate with the Federal Communications Commission (FCC) to add a caller menu option for peer support into the 988 Lifeline. (E.g., “Press 4 for peer support.”)
4. The PSTF should coordinate with the FCC and U.S. Digital Service to implement a telephone triage, so the service user can submit a request for a specific kind of peer support and then be routed to a PSW on shift who has a lived experience that best matches the submitted request.
5. The PSTF should facilitate the 988 Lifeline’s partnership with existing local and national peer support organizations and warmlines. Partnering with these existing organizations would bolster the 988 Lifeline’s capacity to provide peer support. Furthermore, states that already have a strong peer support certification in place could easily integrate their trained PSWs into the 988 Lifeline services using their existing infrastructure and expertise.
6. The PSTF should coordinate with the FCC to incorporate a peer support text messaging option within the 988 Lifeline’s text and chat services. (For example, service users could text “PEER” to 9-8-8 and be routed to a PSW on shift.)
7. The PSTF should implement a public campaign to the general public clarifying that the 988 Lifeline will remain as a suicide and crisis hotline, but it will also provide access to broader peer support services. The available peer support services should be clearly outlined on the 988 Lifeline website.

PSWs should work in call centers alongside 988 Lifeline phone and text specialists. 

Recommendation 3. Develop an action plan to fund and sustain the integration of the peer support service.

The peer support service would need funding to become integrated into the 988 Lifeline. The government has recently approved funds for mental health initiatives, such as with the Restoring Hope for Mental Health and Well-Being Act of 2022. In 2023, HHS announced an additional $200 million in funding for the 988 Lifeline, but overall, HHS has granted almost $1.5 billion in total toward the 988 Lifeline. Similar avenues of funding should help jumpstart the integration of the peer support service.

For continued maintenance, fees for the peer support service should apply in a similar fashion to 9-1-1. That is, service users should not pay each time they access the 988 Lifeline or its integrated peer support service. Some U.S. states have already passed 9-8-8 implementation legislation that allows a monthly flat fee to be collected through telephone and wireless service providers, as permitted in the “National Suicide Hotline Designation Act of 2020”. The remaining states should be encouraged to pass similar legislation. The fee should remain in an account that is spent only for the maintenance of the 988 Lifeline and peer support services. If a fee is collected, then the FCC should provide an annual report on these fees and their usage.

Funding for the peer support service’s integration into the 988 Lifeline would entail the following:

• Maintenance of the peer support service
• Financial compensation for trainers who will train and mentor the PSWs
• Recruitment of trainers and PSWs
• The development of training resources for PSWs

Recommendation 4. Establish state-level standardized peer support training and certification. 

PSWs should learn skills that are commonly taught to 988 Lifeline specialists, including active listening and recovery-oriented language. They should learn how to share their own stories, navigate challenging conversations, maintain boundaries, and self-care. Their training should be standardized at the state level, and it should be based on the “National Model Standards for Peer Support Certification” established by SAMHSA. 

While most U.S. states have some version of peer support certification for mental health and/or substance use recovery, the PSTF should work with advocacy organizations to ensure that the state-level standardized training accounts for the peer support needs and demographics of each state. The peer support training should address the needs of people with a diverse range of lived experiences. Peer support needs can also be studied using caller outcome data that are recorded by 988 Lifeline specialists.

The PSTF should recruit trainers who will train and mentor the PSWs. To start, the PSTF should liaise within SAMHSA and with existing peer support organizations to coordinate this recruitment.

Recommendation 5. Establish a nation-wide system for the recruitment and training of PSWs.

Recruit individuals who would like to use their own lived experience to help other community members. Recruitment should occur through hospitals, clinics, as well as peer-run and community-based organizations to maximize recruitment pathways. 

Current 988 Lifeline phone and text specialists could also be good candidates for the peer support service. Many are motivated by their own lived experiences and are already trained to handle calls across multiple helplines. 988 Lifeline specialists are instructed to focus on the service user seeking help and not share about themselves. However, specialists’ own lived experiences––if they are comfortable sharing them––represent untapped potential.

Once recruited, individuals who are training to become PSWs should attend live training sessions online with a peer cohort.

Recommendation 6. Expand the peer support service to cover a diverse range of lived experiences.

After successfully establishing the peer support service, it should be expanded upon to provide support for a broad and diverse range of lived experiences. The available peer support services should continue to be updated and outlined on the 988 Lifeline website.

Conclusion

A peer support service should be integrated into the 988 Lifeline. A service that caters to all kinds of lived experience paves way for a more empowered and self-reliant community. It fosters a societal mindset of helping each other based on shared lived experience in an empathic and healthy way. Peer support empowers both the PSW and the service user. While the service user finds empathy and understanding, the PSW finds a renewed sense of purpose and confidence. In this way, peer support would alleviate loneliness and isolation that result from a variety of causes while instilling longer-term resilience into the community.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

What is a service user?

A service user refers to any individual who uses the peer support service for assistance.

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What if peer support workers (PSWs) become distressed or emotionally fatigued?

Peer support work can be empowering and healing for those in recovery. However, as with any emotionally challenging work, PSWs benefit from ongoing support and supervision. Some interactions can be draining, especially if they hit too close to home. It is common for 988 Lifeline call centers to have a trained staff member, such as a psychologist or therapist, on call for such situations. A PSW could use this resource to debrief or process as needed. Additionally, during recruitment, PSW candidates should be screened to ensure they are comfortable speaking about their own lived experience and helping others who are going through the same experience.

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How would PSWs be compensated?

Most PSWs would be compensated in the same way as their 988 Lifeline call and text specialist counterparts. They would be compensated with rigorous ongoing training, support, and resources for recovery and self-care in return for their time. They would also benefit from a social support system of fellow PSWs. Some individuals who may be ideal candidates for peer support work may struggle to find employment and health insurance. They will be less likely to volunteer if they do not have a living wage. To maximize the range of lived experiences available, certain individuals should be eligible for financial compensation.

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For the peer support phone and text service, how is a caller or texter connected with a PSW who has the same lived experience?

A service user’s phone call or text should be routed to a 988 Lifeline peer support operator or telephone triage, where the service user is asked to say aloud (or type) what kind of support they are searching for (e.g., “I want to speak with someone who has been in prison.”) Then, the service user’s call (or text) would be routed to a PSW (under an alias) anywhere in the United States who 1) is currently on shift and 2) has a lived experience that is closest to the service user’s request. Each PSW would have associated keywords, such as “former incarceration,” “PTSD,” or “living alone,” which means that they are trained to connect with any service user about those lived experiences. The PSW would follow the service user’s lead in the conversation, and the PSW could share parts of their own lived experience when appropriate.

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Why should the peer support service include a text messaging option?

Text messaging can be more accessible than a phone line for youths and people with disabilities. The 988 Lifeline includes a text messaging option for this same reason.

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Why should we integrate another option into the 988 Lifeline when some states still struggle to find sustainable ways to fund and staff the 988 Lifeline as it currently is?

It is true that both the regular 988 Lifeline and peer support service would provide resources and emotional support. By incorporating peer support into the 988 Lifeline, existing local and national peer support organizations would be eligible to partner with the 988 Lifeline and bolster its capacity to provide peer support. This endeavor will help with some staffing concerns. Furthermore, the peer support service would cover a diverse range of lived experiences extending beyond mental health. Therefore, more individuals may be motivated to join the 988 Lifeline staff to share their unique lived experience and help others who feel the same way.

Integrating a versatile peer support service into the 988 Lifeline transforms the latter into a service that every single American can use. (Every American has some unique lived experience.) The service’s versatility may help incentivize the remaining states to pass legislation to collect a 988 Lifeline fee through telephone and wireless service providers.

Finally, peer support is a cost-effective, preventative intervention. It should help remove the burden on other federal services, thereby reducing overall spending in time.

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What happens next?

After implementing the action plan outlined in this memo, a subsequent memo should outline how to integrate peer support work into the community in person and on a large scale. Incorporating peer support into the 988 Lifeline would show its effectiveness to the public, policymakers, and healthcare professionals. This credibility would bolster endeavors to integrate peer support work into community settings throughout the country (e.g., behavioral health centers, hospitals and emergency rooms, and community clinics). These endeavors could also lead to professionalizing peer support, so PSWs can be reimbursed through Medicaid programs and health insurance.

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The federal government should expand the FDA’s priority review voucher program (PRV) and provide market exclusivity advantages to encourage the development of medications for addiction. 

Taken together, substance use disorders (alcohol, cigarettes, and other drugs) cause more deaths in the U.S. every year than cancer or heart disease and cause devastating downstream social harms. Despite this, only 3% of eligible patients received substance use disorder (SUD) medication, a result of low uptake and efficacy of existing medications and a lack of options for patients addicted to stimulants. This is due to a near-total absence of pharmaceutical research and development activity. To make population level impact to reduce harms from opioids, methamphetamine, cocaine, alcohol, and cigarettes, we must address the broken market dynamics in addiction medicine. 

The PRV program should be expanded to cover opioid use disorder, alcohol use disorder, stimulant use disorder, and smoking. In addition, drugs that are approved for these SUD indications should have extended exclusivity and sponsors that develop these medications should receive vouchers to extend exclusivity for other medications.

Challenge and Opportunity 

Addiction policy efforts on both the left and the right have struggled. Despite substantial progress reducing smoking, 29 million Americans still smoke cigarettes and feel unable to quit and 480,000 Americans die each year from smoking. While overdose deaths from opioids, cocaine, and methamphetamine have fallen slightly from their peak in 2022, they are still near record highs, three  times higher than 20 years ago. Alcohol deaths per capita have doubled since 1999. 

Roughly 60% of all crimes and 65% of violent crimes are related to drugs or alcohol; and the opioid crisis alone costs the United States $1.5 trillion a year. Progress in reducing addiction is held back because people with a substance use disorder take medication. This low uptake has multiple causes: in opiate use disorder, uptake is persistently low despite recent relaxations of prescription rules, with patients reporting a variety of reasons for refusal; treatments for alcohol use disorder have modest effects; and there are no approved treatments for stimulant use disorder. Only three percent take SUD medications, as shown in figure 1 below [link to image]. In brief, only 2% of those suffering alcohol use disorder, 13% of those with opiate use disorder, 2% of smokers, and approximately 0% of illicit stimulant users are receiving medication, giving a weighted average of about 3%.

There has been rapid innovation in the illicit market as synthetic opioids and expanded meth production have lowered price and increased strength and availability. Meanwhile, there has been virtually no innovation in medicines to prevent and treat addiction. The last significant FDA approval for opioid use disorder was buprenorphine in 2002; progress since then has been minimal, with new formulations or dosing of old medications. For alcohol use disorder, the most recent was acamprosate in 2004 (and it is rarely prescribed due to limited efficacy and three times a day dosing).

None of the ten largest pharmaceutical companies have active addiction medicine programs or drug candidates, and the pharmaceutical industry as a whole has only pursued minimal drug development. According to the trade association BIO, “Venture investment into companies with novel addiction drug programs over the last 10 years is estimated at $130M, 270 times less than oncology.”

There are promising addiction drug candidates being studied by academics but without industry support they will never become medicines. If pharmaceutical companies spent just 10% of what they spend on obesity therapies, we might quickly make progress.

For example, GLP-1 medicines like Ozempic and Mounjaro have strong anti-addictive effects across substances. Randomized trials and real-world patient health record studies show dramatic drops in consumption of drugs and alcohol for patients taking a GLP-1. Many addiction scientists now consider these compounds to be the biggest breakthrough in decades. However, Novo Nordisk and Eli Lilly, who own the drugs currently in the market, do not plan to run phase 3 addiction trials on them, due to fear of adverse events in substance use disorder populations. The result is that a huge medical opportunity is stuck in limbo indefinitely. Fortunately, Lilly has recently signaled that they will run trials on related compounds, but remain years from approval.

Conversations with industry leaders make clear that large pharmas avoid SUD indications for several reasons. First, their upside appears limited, since current SUD medications have modest sales. Second, like other psychiatric disorders, the problem is challenging given the range and complexity of neurological targets and the logistical challenges of recruiting people with substance use disorder as participants. Finally, companies face downside reputational and regulatory risk if participants, who face high baseline rates of death from overdose regardless, were to die in trials. In the case of Ozempic and Mounjaro, sponsors face an obstacle some have termed the “problem of new uses” – clinical trials of an already lucrative drug for a new indication carry downside risk if new side effects or adverse events are reported. 

Image from Charting the fourth wave, based on CDC data

Plan of Action

Market Shaping Interventions

Recommendation 1. Expand the FDA priority review voucher (PRV) program to include addiction medicine indications.

The FDA priority review voucher (PRV) program incentivizes development of drugs for rare pediatric and infectious diseases by rewarding companies who get drugs approved with a transferable voucher that accelerates FDA approval. These vouchers are currently selling for an average of $100M. The PRV program doesn’t cost the government any money but it makes drug development in the designated categories much more lucrative. The PRV program has proven very successful, leading to a surge in approvals of medications.

As a neglected market with urgent unmet medical and public health needs, and which also promises to benefit the broader public by reducing the negative externalities of addiction, addiction medicine is a perfect fit for the PRV program. Doing so could transform the broken market dynamics of the field. The advantage of the PRV program is that it does not require substantial new congressional appropriations, though it will require Congress giving the FDA authority to expand the PRV program, as it has done previously to add other disease areas.

Recommendation 2. Extend exclusivity for addiction medicines and incentivize pursuit of new indications

Market exclusivity is a primary driver of pharmaceutical industry revenue. Extending exclusivities would have a very large effect on industry behavior and is needed to create sufficient incentives. The duration of exclusivity for alcohol use disorder, opioid use disorder, stimulant use disorder, and smoking cessation indications should be extended along with other incentives.  

• Addiction medicine indications should receive an additional two years of exclusivity for biologics and three  years for small molecules.
• Companies that achieve an indication for a substance use disorder for a medication that represents a significant advance would receive an exclusivity voucher that can be transferred to another medication. For 2nd, 3rd, and 4th SUD indications with the same compound, companies would be granted a shorter duration exclusivity voucher. Durations would be tiered, as described in this proposal from Duke, to balance public interest and reward levels.
• FDA should provide increased consideration for addiction medicines for breakthrough, fast track, and priority review designations, as well as accelerate meeting schedules, all of which substantially reduce development expenses.

For precedent, there are already a number of FDA programs that extend medication exclusivity, including ‘orphan drug exclusivity’ and the qualified infectious disease product (QIDP) program. Like rare diseases and antibiotics, addiction is a market that requires incentives to function effectively. In addition, successful treatments, given the negative externalities of addiction, have public benefit beyond the direct medical impact, and deserve additional public incentives.

Recommendation 3. Modernize FDA Standards of Efficacy for Substance Use Disorder Trials

A significant barrier to pharmaceutical innovation in SUDs is outdated or unpredictable efficacy standards sometimes set by the FDA for clinical trials. Efficacy expectations for substance use disorder indications are often rooted in abstinence-only and other binary measure orientations that the scientific and medical community has moved past when evaluating substance use disorder harms.

This article in the American Journal of Drug and Alcohol Abuse demonstrates that binary outcome measures like ‘number of heavy drinking days’ (NHDD) can underestimate the efficacy of treatments. This recent report from NIAAA on alcohol trial endpoints recommends a shift away from abstinence-based endpoints and towards more meaningful consumption-based endpoints. This approach should be adopted by the FDA for all SUD treatments, not just alcohol.

There are some indications that the FDA has begun modernizing their approach. This recent paper from NIH and FDA on smoking cessation therapies provides updated guidance that moves in the right direction.

More broadly, the FDA should work to adopt endpoints and standards of efficacy that mirror standards in other disease areas. This shift is best achieved through new guidance or statements issued by the FDA, which would offer positive assurance to pharmaceutical companies that they have achievable paths to approval. Predictability throughout the medication development life cycle is absolutely essential for companies considering investment.

Congress should include statements in upcoming appropriations and authorizations that state:

1. The FDA should adopt non-binary standards of efficacy for addiction treatments that are aligned with standards for other common disorders and the FDA shall, within 12 months, report on the standards employed for substance use disorder relative to other prevalent chronic conditions and report steps to eliminate disparities in evidentiary standards and issue new guidance on the subject.
2. The FDA should publish clear guidance on endpoints across SUDs to support planning among pharmaceutical companies considering work in this field.

Conclusion

Sustained focus and investment in diabetes and heart disease treatments has enabled medical breakthroughs. Addiction medicine, by contrast, has been largely stagnant for decades. Stimulating private-sector interest in addiction medicine through regulatory and exclusivity incentives, as well as modernized efficacy standards, is essential for disrupting the status quo. Breakthroughs in addiction medicine could save hundreds of thousands of lives in the US and provide long-term relief for one of our most intractable social problems. Given the negative externalities of addiction, this would also have enormous benefits for society at large, reducing crime and intergenerational trauma and saving money on social services and law enforcement.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

Why doesn’t the private sector target SUD? Why is government incentive necessary?

Per author conversations with industry leaders, private sector interest in SUD medication development is limited for the following reasons:

• The upside of pursuing SUD indications appears limited, since current SUD medications, which are generally targeted for specific substances, have modest sales.


• Even with preliminary evidence that GLP-1 drugs may be efficacious for some SUD indications (e.g, alcohol, opiates, and tobacco), companies are reluctant to pursue label expansion for SUD. As described previously, with already lucrative drugs, companies face a downside risk (termed the “problem of new uses”) from running large clinical trials, and possibly uncovering new side effects or incurring random adverse events which could harm reputation and existing markets.


• In the specific case of SUD, this downside risk might be especially large, since people with substance use disorder have high baseline rates of overdose and death.

Moreover, there is an argument that a treatment for SUD is a public good, to the degree that it ameliorates the negative externalities of addiction – increasing the case for more public-sector incentives for SUD treatment. The end result is that medical treatments for SUD are stuck in an indefinite limbo, with private-sector interest in SUD, as documented previously, being very low.

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Why are we optimistic about SUD medications?

The current lack of effective and widely used SUD medications is disheartening, but this is in the context of private sector disinterest and scant funding. Even modest successes in SUD treatment have the potential to kickstart an innovation loop, akin to the rush of biotech companies hastening to enter the obesity treatment field. Prior to the success of the GLP-1 drugs, obesity treatment had been moribund, and viewed pessimistically in light of drugs that had limited efficacy or had been withdrawn for side effects like suicidality or cardiovascular issues.

An SUD success like GLP-1 for obesity has the potential to kindle a similar rush of interest; the challenge is the initiation of that cascade. Given the very low levels of investment in SUD treatments, there is potential low-hanging fruit that, given sufficient funding, could be trialed and deployed.

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What are the innovations in the illicit drug market?

There has been rapid innovation in the field of addiction, but it’s been happening on the wrong side: addiction-inducing technologies are becoming more powerful, while SUD treatments have largely stagnated. This innovation is most evident in synthetic opioids and methamphetamine.

Compared to heroin, fentanyl is about 25x stronger (on a per-weight basis), and hence, much easier to smuggle. As the Commission on Combating Synthetic Opioid Trafficking put it:

Single-digit metric tonnage of pure fentanyl is not a large amount and could easily fit into a shipping container or a truck trailer, which seriously challenges interdiction…Perhaps as much as 5 MT [metric tons] of pure fentanyl would be needed to satisfy the entire annual U.S. consumption for illegally supplied opioids.

Moreover, as a recent Scientific American article documented, innovations in fentanyl production, including the use of safer precursors and methods that don’t require sophisticated equipment, mean that fentanyl production is now decentralized, and resistant to attempts by law enforcement to shut it down.

As fentanyl has come to dominate the opioid supply over the past 10 years, overdose deaths have risen dramatically. New synthetic opioids and non-opioids like xylazine are also becoming common.

At the same time, due to advances in production techniques in Mexico, methamphetamine production has skyrocketed in recent decades while purity has improved. Worst of all, unlike heroin, fentanyl is easily combined with meth and cocaine in pills and powder.

The DEA has highlighted the presence of “super labs” in Mexico capable of producing hundreds of pounds of meth per batch.

Together, these three innovations (fentanyl, cheap meth, and new combinations) have led to a 400% increase in overdose deaths in the past 20 years. Without equally powerful innovations to reduce addiction rates, we will never make long-term and sustainable progress.

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There are many examples of groundbreaking success in the development of life-saving vaccines, diagnostics, and therapeutics to which we can point in the response to the COVID-19 pandemic, such as the introduction of mRNA vaccines and the accelerated path to its authorization through Operation Warp Speed. However, in anticipation of future known and unknown health security threats, including new pandemics, biothreats, and climate-related health emergencies, our answers need to be much faster, cheaper, and less disruptive to other operations. One path to a more permanent state of readiness is to create a commercial public health emergency payment system to use the full power of commercial healthcare reimbursement, providing clear and tunable market signals to catalyze investment in anticipation and in response to public health emergencies.

Challenge and Opportunity

There are two key problems we have yet to solve. First, how do we break out of the panic/neglect cycle of investments in emergency medical countermeasures (MCMs), i.e invest more in prevention and preparedness than in response? Secondly, how can we avoid any friction in capital (both public and private) once there is an emergency, while preserving the ability to fine tune incentives as needs evolve?

Many of the most promising and impactful tools applicable to emerging infectious diseases and public health emergency (PHE) management more broadly (e.g. wastewater surveillance, home testing, vaccinations, improved indoor air quality), face strong headwinds due to small, poorly defined, and/or unstable markets, significantly reducing private investment in them and relying on seemingly stochastic public investments by a fragmented set of federal, state, and local agencies.

Additionally, there is a prevailing assumption within the health security community that it operates largely outside the commercial U.S. healthcare system due to lack of private incentives (as opposed to, for instance, the development and use of cancer therapies). This, however, reflects a policy decision and not fundamental underlying market demand. And yet there remain two key realities to contend with: pandemic-related demand is largely unpredictable, and we have, thus far, been unable to effectively amortize pandemic costs into interpandemic periods.

U.S. health care insurers process more than nine  billion claims for payment each year  – a process which features a sophisticated, standardized accounting system that is widely understood by the entire healthcare industry; it is also a powerful signal of future market expectations that drives private and public R&D investment decisions.

Plan of Action 

The U.S. government should create a prospective healthcare reimbursement code set that can anticipate the need for any product or service in the context of PHEs, including MCMs and infrastructure-based countermeasures. The goal would be to provide clear market signals and pull incentives, to encourage and accelerate development and appropriate utilization of medical countermeasures (diagnostics, vaccines, therapies, early warning detection, and others). This would complement other strategies, such as advanced R&D investments made by federal funding agencies including the Biomedical Advanced Research & Development Authority (BARDA). Creating clear reimbursement pathways would likely immediately attract private investment in MCMs in ways that are notoriously difficult currently and help enable rapid response to public health emergencies.

The development and management of this reimbursement system should be housed within the Centers for Medicare and Medicaid Services (CMS), and would require introduction of legislation clearly authorizing CMS to pay for products and services under EUA and use of prospective payment policies. 

There are a variety of additional benefits to using a payment system like this for emergency response. This system could be a unique and core source of surveillance data, through conditions of payment policies, that can be used to provide intelligence and manage evolving emergencies such as outbreaks and pandemics, significantly reducing the need for additional data collection systems – need which proved to be a major bottleneck during COVID-19. Prospective codesets are not common in public and private insurance, but the existence of them would likely serve as a new and powerful tool for private investment in a capability that would be certain to have public health benefit were it to exist.

We propose that reimbursable services be categorized into three tiers.

Tier 1. Existing and prospective medical products/services under FDA EUA

This is the set of regulated medical products that would typically be considered for emergency use authorization by the FDA. It can include infectious disease diagnostics, vaccinations, and therapeutics. It can even include the use of repurposed generic drugs to mitigate potential drug shortages.

Tier 2. Existing public health products/services typically not requiring FDA approvals, but may have other regulatory hurdles

There are a variety of products and services not considered medical products but nonetheless play critical roles not only in response but in prevention of public health emergencies. Many of these technologies struggle to find stable markets in which to operate and are relegated to the sidelines. This includes genomic surveillance, remnant sample sequencing, or other surveillance testing capabilities, early warning systems, use of commercial wearables as a check engine light for possible infection prior to symptom onset. Many of these technologies need to be “always on” to be most effective.

Tier 3. Prospective public health products/services typically not requiring FDA approvals, but may have other regulatory hurdles

This category deviates from current models of healthcare reimbursement, because it is comprised of interventions that are carried out by service providers outside of healthcare delivery, but which nonetheless have high impact potential. This can include indoor air quality upgrades, or wastewater detection. Again, the commercialization of indoor air quality is in part impeded by poorly defined markets. 

Value-based care models

While the above items are largely “fee for service” payment models, we can also envision the use of value-based care models here, focusing on community outcomes and providing flexibility to communities or other systems to achieve them. This can include models to prevent hospitalization due to PHE (e.g. COVID-19), prevent community transmission (could be directed at local public health agencies or other agents), herd immunity vaccination rates, etc.

Conclusion 

One of the biggest frustrations amongst the life science and medical device communities in the COVID-19 response was that the government was not clear about target product profiles and advanced market commitments for the full range of products and services needed. These types of systems, if implemented early, would have sent clear and powerful signals to the market that would have quickly unlocked the necessary private sector investment needed to expedite product development needed for the response. Using the already widely adopted and understood commercial healthcare reimbursement system to incentivize and pay for prospective emergency product development and delivery is a novel, powerful, and turnkey approach to pandemic preparedness. 

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

We propose the establishment of a Department of Health and Human Services Loan Programs Office (HHS LPO) to fill critical and systematic gaps in financing that prevent innovative life-saving medicines and other critical health technologies from reaching patients, improving health outcomes, and bolstering our public health. To be effective, the HHS LPO requires an authority to issue or guarantee loans, up to $5 billion in total. Federally financed debt can help fill critical funding gaps and complement ongoing federal grants, contracts, reimbursement, and regulatory policies and catalyze private-sector investment in innovation.

Challenge and Opportunity

Despite recent advances in the biological understanding of human diseases and a rapidly advancing technological toolbox, commercialization of innovative life-saving medicines and critical health technologies face enormous headwinds. This is due in part to the difficulty in accessing sustained financing across the entire development lifecycle. Further, macroeconomic trends such as non-zero interest rates have substantially reduced deployed capital from venture capital and private equity, especially with longer investment horizons. 

The average new medicine requires 15 years and over $2 billion to go from the earliest stages of discovery to widespread clinical deployment. Over the last 20 years, the earliest and riskiest portions of the drug discovery process have shifted from the province of large pharmaceutical companies to a patchwork of researchers, entrepreneurs, venture capitalists, and supporting organizations. While this trend has enabled new entrants into the biotechnology landscape, it has also required startup companies to navigate labyrinthine processes of technical regulatory guidelines, obtaining long-term and risk-friendly financing, and predicting payor and provider willingness to ultimately adopt the product.

Additionally, there are major gaps in healthcare infrastructure such as lack of adequate drug manufacturing capacity, healthcare worker shortages, and declining rural hospitals. Limited investment is available for critical infrastructure to support telehealth, rural healthcare settings, biomanufacturing, and decentralized clinical trials, among others.

The challenges in health share some similarities to other highly regulated, capital-intensive industries, such as energy. The Department of Energy (DOE) Loan Program Office (LPO) was created in 2005 to offer loans and loan guarantees to support businesses in deploying innovative clean energy, advanced transportation, and tribal energy projects in the United States. LPO has closed more than $40 billion in deals to date. While agencies across HHS rely primarily on grants and contracts to deploy research and development (R&D) funding, capital-intensive projects are best deployed as loans, not only to appropriately balance risk between the government and lendees but also to provide better stewardship over taxpayer resources via mechanisms that create liquidity with lower budget impact. Moreover, private-sector financing rates are subject to market-based interest rates, which can have enormous impacts on available capital for R&D.

Plan of Action

There are many federal credit programs across multiple departments and agencies that provide a strong blueprint for the HHS LPO to follow. Examples include the aforementioned DOE Loan Programs Office, which provides capital to scale large-scale energy infrastructure projects using new technologies, and the Small Business Administration’s credit programs, which provide credit financing to small businesses via several loan and loan matching programs.

Proposed Actions

We propose the following three actions:

• Pass legislation authorizing the HHS LPO to make or guarantee loans supporting the development of critical medicines that serve unmet or underserved public health needs.
• Establish the LPO as a staffing division within HHS.
• Appropriate a budget to support the staffing and operations of the newly created HHS LPO.

Scope

Similar to how DOE LPO services the priorities of the DOE, the HHS LPO would develop strategy priorities based on market gaps and public health gaps. It would also develop a rigorous diligence process to prioritize, solicit, assess, and manage potential deals, in alignment with the Federal Credit Reform Act and the associated policies set forth by the Office of Management and Budget and followed by all federal credit programs. It would also seek companion equity investors and creditors from the private sector to create leverage and would provide portfolio support via demand-alignment and -generation mechanisms (e.g., advance manufacturing commitments and advanced market commitments from insurers).

We envision several possible areas of focus for the HHS LPO:

1. Providing loans or loan guarantees to amplify investment funds that use venture capital or other private investment tools, such as early-stage drug development or biomanufacturing capacity. While these funds may already exist, they are typically underpowered.
2. Providing large-scale financing in partnership with private investors to fund major healthcare infrastructure gaps, such as rural hospitals, decentralized clinical trial capacity, telehealth services, and advanced biomanufacturing capacity.
3. Providing financing to test new innovative finance models, e.g. portfolio-based R&D bonds, designed to attract additional capital into under-funded R&D and lower financial risks.

Conclusion

To address the challenges in bringing innovative life-saving medicines and critical health technologies to market, we need an HHS Loan Programs Office that would not only create liquidity by providing or guaranteeing critical financing for capital-intensive projects but address critical gaps in the innovation pipeline, including treatments for rare diseases, underserved communities, biomanufacturing, and healthcare infrastructure. Finally, it would be uniquely positioned to pilot innovative financing mechanisms in partnership with the private sector to better align private capital towards public health goals.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

What is the DOE Loan Programs Office, and how is it similar to the proposed HHS Loan Programs Office?

The DOE LPO, enabled via the Energy Policy Act of 2005, enables the Secretary of Energy to provide loan guarantees toward publicly or privately financed projects involving new and innovative energy technologies.

The DOE LPO provides a bridge to private financing and bankability for large-scale, high-impact clean energy and supply chain projects involving new and innovative technologies. It also expands manufacturing capacity and energy access within the United States. The DOE LPO has enabled companies involving energy and energy manufacturing technologies to achieve infrastructure-scale growth, including Tesla, an electric car manufacturer; Lithium Americas Corp., a company supplying lithium for batteries; and the Agua Caliente Solar Project, a solar power station sponsored by NRG Solar that was the largest in the world at its time of construction.

The HHS LPO would similarly augment, guarantee, or bridge to private financing for projects involving the development and deployment of new and innovative technologies in life sciences and healthcare. It would draw upon the structure and authority of the DOE LPO as its basis.

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What potential use cases would the HHS LPO serve?

The HHS LPO could look to the DOE LPO for examples as to how to structure potential funds or use cases. The DOE LPO’s Title 17 Clean Energy Financing Program provides four eligible project categories: (1) projects deploying new or significantly improved technology; (2) projects manufacturing products representing new or significantly improved technologies; (3) projects receiving credit or financing from counterpart state-level institutions; and (4) projects involving existing infrastructure that also share benefits to customers or associated communities.

Drawing on these examples, the HHS LPO could support project categories such as (1) emerging health and life science technologies; (2) the commercialization and scaling access of novel technologies; and (3) expanding biomanufacturing capacity in the United States, particularly for novel platforms (e.g., cell and gene therapies).

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How much would the HHS LPO cost?

The budget could be estimated via its authority to make or guarantee loans. Presently, the DOE LPO has over $400 billion in loan authority and is actively managing a portfolio of just over $30 billion. Given this benchmark and the size of the private market for early-stage healthcare venture capital valued at approximately $20 billion, we encourage the creation of an HHS LPO with $5 billion in loan-making authority. Using proportional volume to the $180 million sought by DOE LPO in FY2023, we estimate that an HHS LPO with $5 billion in loan-making authority would require a budget appropriation of $30 million.

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What accountability or oversight measures are required to ensure proper operation and evaluate performance?

The HHS LPO would be subject to oversight by the HHS Inspector General, OMB, as well as the respective legislative bodies, the House of Representatives Energy and Commerce Committee and the Senate Health, Education, Labor and Pension Committee.

Like the DOE LPO, the HHS LPO would publish an Annual Portfolio Status Report detailing its new investments, existing portfolio, and other key financial and operational metrics.

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What alternative options could serve the same purpose as the HHS LPO, and why is the HHS LPO preferable?

It is also possible for Congress to authorize existing funding agencies, such as BARDA, the Advanced Research Projects Agency for Health (ARPA-H), or the National Institutes for Health (NIH), with loan authority. However, due the highly specialized talent needed to effectively operate a complex loan financing operation, the program is significantly more likely to succeed if housed into a dedicated HHS LPO that would then work closely with the other health-focused funding agencies within HHS.

The other alternative is to expand the authority for other LPOs and financing agencies, such as the DOE LPO or the U.S. Development Finance Corporation, to focus on domestic health. However, that is likely to create conflicts of priority given their already large and diverse portfolios.

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What are the next steps required to stand up the HHS LPO?

The project requires legislation similar to the Department of Energy’s Title 17 Clean Energy Financing Program, created via the Energy Policy Act of 2005 and subsequently expanded via the Infrastructure Investment and Jobs Act in 2021 and the Inflation Reduction Act in 2022.

This legislation would direct the HHS to establish an office, presumably a Loan Programs Office, to make loan guarantees to support new and innovative technologies in life sciences and healthcare. While the LPO could reside within an existing HHS division, the LPO would most ideally be established in a manner that enables it to serve projects across the full Department, including those from the National Institutes of Health, Food and Drug Administration, Biomedical Advanced Research and Development Authority, and the Centers for Medicare and Medicaid Services. As such, it would preferably not reside within any single one of these organizations. Like the DOE LPO, the HHS LPO would be led by a director, who would be directed to hire the necessary finance, technical, and operational experts for the function of the office.

Drawing on the Energy Policy Act of 2005 that created the DOE LPO, enabling legislation for the HHS Loan Programs office would direct the Secretary of HHS to make loan guarantees in consultation with the Secretary of Treasury toward projects involving new and innovative technologies in healthcare and life sciences. The enabling legislation would include several provisions:

• Necessary included terms and conditions for loan guarantees created via the HHS LPO, including loan length, interest rates, and default provisions;


• Allowance of fees to be captured via the HHS LPO to provide funding support for the program; and


• A list of eligible project types for loan guarantees.

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Who are potential supporters of this policy? Who are potential skeptics?

Supporters are likely to include companies developing and deploying life sciences and healthcare technologies, including early-stage biotechnology research companies, biomanufacturing companies, and healthcare technology companies. Similarly, patient advocates would be similarly supportive because of the LPO’s potential to bring new technologies to market and reduce the overall Weighted Average Cost of Capital (WACC) for biotechnology companies, potentially supporting expanded access.

Existing financiers of research in biomedical sciences technology may be neutral or ambivalent toward this policy. On one hand, it would provide expanded access to syndicated financing or loan guarantees that would compound the impact of each dollar invested. On the other hand, most financiers currently use equity financing, which enables the demand for a high rate of return via subsequent investment and operation. An LPO could provide financing that requires a lower rate of return, thereby diluting the impact of current financiers in the market.

Skeptics are likely to include groups opposing expansions of government spending, particularly involving higher-risk mechanisms like loan guarantees. The DOE LPO has drawn the attention of several such skeptics, oftentimes leading to increased levels of oversight from legislative stakeholders. The HHS LPO could expect similar opposition. Other skeptics may include companies with existing medicines and healthcare technologies, who may be worried about competitors introducing products with prices and access provisions that have been enabled via financing with lower WACC.

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The world is aging. Today, some two thirds of the global population is dying from an age-related condition. Biological aging imposes significant socio-economic costs, increasing health expenses, reducing productivity, and straining social systems. Between 2010 and 2030,  Medicare spending is projected to nearly double – to $1.2 trillion per year. Yet the costly diseases of aging can be therapeutically targeted before they become late-stage conditions like Alzheimer’s. Slowing aging could alleviate these burdens, reducing unpaid caregivers, medical costs, and mortality rates, while enhancing productivity.  But a number of market failures and misaligned incentives stand in the way of extending the healthy lifespan of aging populations worldwide. New solutions are needed to target diseases before they are life-threatening or debilitating, moving from retroactive sick-care towards preventative healthcare.  

The new administration should establish a comprehensive framework to incentivize the discovery, validation, and regulatory approval of biomarkers as surrogate endpoints to accelerate clinical trials and increase the availability of health-extending drugs. Reliable biomarkers or surrogate endpoints could meaningfully reduce clinical trial durations, and enable new classes of therapeutics for non-disease conditions (e.g., biological aging). An example is how LDL (a surrogate marker of heart health) helped enable the development of lipid-lowering drugs. The current lack of validated surrogate endpoints for major late-life conditions is a critical bottleneck in clinical research. Because companies do not capture the majority of the benefit from the (expensive) validation of biomarkers, the private sector under-invests in biomarker and surrogate endpoint validation. This leads to countless lives lost and to trillions of public dollars spent on age-related conditions that could be prevented by better-aligned incentives.  It should be an R&D priority for the new administration to fund the collection and validation of biomarkers and surrogate endpoints, then gain regulatory approval for them. As we explain below, the existing FNIH Biomarkers Consortium does not fill this role.

Currently, companies are understandably hesitant to invest in validation without clear rewards or regulatory pathways. The proposed framework would encourage private companies and laboratories to contribute their biomarker data to a shared repository. This repository would expedite regulatory approval, moving away from the current product-by-product assessment that discourages data sharing and collaboration. Establishing a broader pathway within the FDA for standardized biomarker approval would allow validated biomarkers to be recognized for use across multiple products, reducing the existing incentives to safeguard data while increasing the supply of validated biomarkers and surrogate endpoints. Importantly, this would accelerate the development of drugs which holistically extend the healthspan of aging populations in the U.S. by preventing instead of treating late-stage conditions. (Statins similarly helped prevent millions of heart attacks.)

Key players such as the FDA, NIH, ARPA-H, and BARDA should collaborate to establish a streamlined pathway for the collection and validation of biomarkers and surrogate endpoints, allowing these to be recognized for use across multiple products. This initiative aligns with the administration’s priorities of accelerating medical innovation and improving public health with the potential to add trillions of dollars in economic value by making treatments and preventatives available sooner. This memo outlines a framework applicable to various diseases and conditions, using biological aging as a case study where the validation of predictive and responsive biomarkers may be vital for significant breakthroughs. Other critical areas include Alzheimer’s disease and amyotrophic lateral sclerosis (ALS), where the lack of validated surrogate endpoints significantly hinders the development of life-saving and life-improving therapies. By addressing these bottlenecks, we can unlock new avenues for medical advancements that will profoundly improve public health and mitigate the fast-growing, nearly trillion-dollar Medicare spend on late-life conditions.

Challenge and Opportunity

By 2029, the United States will spend roughly $3 trillion dollars  yearly – half its federal budget – on adults aged 65 and older. A good portion of these funds will go towards Medicare-related expenses that could be prevented. Yet the process of bringing preventative drugs to market is lengthy, costly, and currently lacking in commercial incentives. Even for therapeutics that target late-stage diseases, drug development often takes 10+ years and cost estimates range between $300 million to $2.8 billion. This extensive duration and expense are due, in part, to the reliance on traditional clinical endpoints, which require long-term observation and longitudinal data collection. The burden of chronic diseases is growing, and better biomarkers and surrogate endpoints are needed to accelerate the development of therapeutics that prevent non-communicable diseases and age-related decline. Chronological age, for instance, is a commonly used but inadequate surrogate marker for biological age. This means that, to date, clinical trials on therapeutics designed to improve the biology of aging take decades to validate, rather than years. As a result, pharmaceutical companies find more short-term rewards in treating late-stage diseases, since developing drugs that reduce overall age-related decline requires longer and currently uncertain endpoints.

The validation of reliable biomarkers and surrogate endpoints offers a promising solution to this challenge. Biological measures often correlate with and predict clinical outcomes, and can therefore provide early indications of whether a treatment is effective. If sufficiently predictive, biomarkers can serve as surrogate clinical endpoints, potentially reducing the duration and cost of clinical trials. Validated biomarkers must accurately predict clinical outcomes and be accepted by regulatory authorities, yet the validation process is underfunded due to insufficient commercial incentives for individual agents to share their biomarkers to be used as a public good. (From a purely financial standpoint, companies are better off targeting diseases with known endpoints.) 

The most prominent existing efforts to advance biomarkers and surrogate endpoints are the Foundation for the National Institute of Health’s (FNIH) Biomarkers Consortium and the FDA’s Biomarker Qualification Program. Established in 2006, the Biomarkers Consortium is a public-private partnership aimed at advancing the development and use of biomarkers in medical research. Meanwhile, the FDA’s qualification program was the result of the 21st Century Cures Act, passed in 2016, which underscored the critical role biomarkers play in accelerating medical product development. The Act mandated the FDA to implement a more transparent and efficient process for biomarker qualification. 

Despite the Consortium’s ambitious goals, the rate of biomarker qualification by the FDA has been slow. Since its inception in 2006, only a small number of biomarkers have been successfully qualified. This sluggish progress has been a source of criticism for stakeholders, especially given the high level of resources and collaboration involved. For example, the process of validating biomarkers for osteoarthritis under the Consortium’s “PROGRESS OA” project has been ongoing since Phase 1 and still faces hurdles before full qualification​. We are of the view that this is the result of two issues. Firstly, the qualification process, which involves FDA approval, is seen as overly complex and time-consuming. Despite the 21st Century Cures Act aiming to streamline the process, resulting in the qualification pathway, it remains a significant challenge. The difficulty in navigating the regulatory landscape can limit the impact of Biomarkers Consortium (BC) projects. The Kidney Safety Project, for example, faced substantial regulatory hurdles before finally achieving the first qualification of a clinical safety biomarker​. Secondly, even though the Consortium operates in a precompetitive space, there are ongoing challenges related to data sharing. Companies may still hesitate to share critical data that could advance biomarker validation out of concern for losing a competitive edge, which hampers collaboration​. To address these issues, it is crucial to implement a framework that promotes data sharing in the academic and private sectors, providing strong incentives for the validation and regulatory approval of biomarkers, while improving regulatory certainty with a standardized regulatory process for surrogate endpoint validation.

The current boom in biotechnology underscores the urgency of addressing persisting inefficiencies. Without changes, we face a significant bottleneck in proving the efficacy of new drugs. This is exacerbated by Eroom’s Law—the observation that drug discovery is becoming slower and more expensive over time. This growing inefficiency threatens to hinder the development of new, life-saving treatments at a time when the American population is aging and rapid medical advancements are crucial to deter increasing medical and social costs. In just 11 years—between 2018 and 2029—the U.S. mandatory spending on Social Security and Medicare will more than double, from $1.3 trillion to $2.7 trillion per year. Yet the costly diseases of aging can be therapeutically targeted before they become late-stage conditions like Alzheimer’s.  For federal policymakers, taking immediate action to improve data sharing and biomarker validation processes is vital. Failure to do so will not only stifle innovation but also delay the availability of critical therapies that could save countless lives and accelerate economic growth in the long run. Prompt policy intervention is essential to capitalize on the current advancements in biotechnology and ensure the development of new life-saving tests, tools, and drugs.

Implementing pull-incentives for data sharing now can help the United States adjust to its new demographic structure, where adults in advanced age prevail, while fertility rates decline.  It can also mitigate the escalating costs and timelines of clinical trials, and accelerate the approval of life-saving, health-extending drugs. If our proposed framework is successfully implemented, a robust pool of biomarker data will be established, significantly facilitating the discovery and validation of biomarkers. This will result in several key advancements, including shortened clinical trial durations, increased R&D investment, faster drug approvals, and even increased drug efficacy. Additionally, new drug classes targeting non-disease endpoints, such as biological aging, could be developed. Just as the discovery of LDL as a surrogate marker of heart health was critical in enabling the testing and development of statins, the discovery of clinical-grade biomarkers may unlock new therapeutics designed to target the mechanisms that drive human aging, slowing down the progression of age-related diseases (like cancers) before they become deadly and socio-economically expensive.

Plan of Action

To address the challenge of inefficient data sharing, validation, and approval of biomarkers, we propose implementing a series of pull-incentives aimed at encouraging pharmaceutical companies to contribute their relevant biomarker data to a shared repository and undertake the necessary research and analysis for public validation. These validated biomarkers can then be formally accepted by regulators as surrogate endpoints for drug approval, accelerating the drug development process and reducing late-life costs.

Recommendation 1. An NIH-FDA initiative for Biomarkers and Surrogate Endpoints Within the NIA

Most existing agencies focus on single, often late-stage diseases. This is at odds with a holistic understanding of human biology. A new initiative within the National Institute on Aging (NIA) could be devoted to the discovery, collection, and validation of biomarkers and surrogate endpoints for overall human health and age-related decline. Most National Institutes of Health funds are currently devoted to the diseases of aging (think cancers, Alzheimer’s, heart disease, or Parkinson’s.) Within the NIA, research on Alzheimer’s disease alone receives roughly eight  times more funding than the biology of aging, with few human-relevant results. Every federal agency and U.S. individual would benefit from better biomarkers of long-term health and from an understanding of how to measure the biology of aging. Yet no single agent has the incentives to collect and validate this data, for instance by shouldering the costs of validating predictive and responsive biomarkers of aging.

This new initiative could also be devoted to the development of preclinical, human-relevant methodologies that could broadly facilitate or streamline drug development. In 2022, the FDA Modernization Act 2.0 approved the use of in vitro and in silico New Approach Methodologies (NAMs) like cell-based assays (e.g. organs-on-chips) or computer models (like virtual cells) in preclinical development to reduce or replace animal studies, especially “where no pharmacologically relevant animal species exists.” This may be the case for human aging, where no single animal model reflects the full complex biology of our aging process. 

At present, these technologies cannot accurately represent the multifactorial processes of aging, and they cannot model entire organisms. Much work remains to be done to even understand how to “code” aging into organs-on-chips. Yet if supplemented by approaches like in vivo pooled screening, next generations of human-relevant in vitro or in silico methodologies (like virtual cells) could be infused with the complex data needed to accelerate clinical trial results and increase drug efficacy. For in vitro and in silico models to reproduce key aspects of aging biology, a better understanding of how human aging works in living organisms  — and what markers to include to represent it either virtually or in vitro — may be needed. Yet pharmaceutical companies, startups, health insurance firms, and even research hospitals again lack the incentives to shoulder the costs of collecting and validating this type of data. This means a new office within a federal agency may be needed to supply these incentives.

Recommendation 2. New Data-sharing Incentives 

The specific incentives used would need to be developed in collaboration with policymakers and industry stakeholders, but a few are outlined below: 

Pull-incentives 

One possibility is offering transferable Priority Review Vouchers (PRVs) or similar pull incentives to companies that share their biomarker data. PRVs are currently awarded by the FDA to companies developing drugs for neglected tropical diseases, rare pediatric diseases, or medical countermeasures. A PRV allows the holder to expedite the FDA review of another drug from 10 months to 6 months, and holds significant financial value. Offering transferable PRVs for drugs designed to target biological aging, for instance, could create the incentives needed for pharmaceutical companies to target early-stage age-related conditions before they turn into diseases.  

The creation of a new PRV category would require legislative action. Our proposed NIH-FDA initiative would be well positioned to oversee the issuance of PRVs, working with government agencies and think tanks to determine, for instance, what an “aging therapeutic” means, and what a company needs to achieve to gain a PRV for a longevity drug. The Alliance for Longevity Initiatives, for instance, has developed an advanced approval pathway for health-extending drugs that directly target the biology of aging. Another possible strategy would be for the FDA to encourage drugs that target multiple disease indications at once, perhaps offering discounts or incentives for every extra biomarker or surrogate endpoint validated. This could effectively encourage the development of drugs that do more than marginally improve on existing interventions. 

We acknowledge that an overabundance of PRVs can saturate the market, decreasing their value and weakening the intended pull-incentive for pharmaceutical innovation. A response would be to demand that proposals to issue additional PRVs include a comprehensive market impact analysis to mitigate unintended economic consequences. Expanding the number of PRVs can also place extra demands on the FDA’s limited resources, potentially leading to longer approval times for other essential medications, even though PRV holders often delay redemption, preventing an immediate influx of priority review applications. The PRV system may inadvertently favor larger, well-established pharmaceutical companies that have the means to acquire and leverage PRVs effectively, creating barriers for smaller firms and startups. These are all spill-over problems worth solving for the potential upshot of mitigating late-life disease costs and encouraging drugs that holistically improve the human healthspan.  

Biomarker Data Sharing as a Condition of Federal Funding

Federal funding recipients are legally obligated to make their research publicly accessible through agency-specific policies aimed at advancing open science. This mandate was strengthened by the 2022 OSTP Memorandum. Despite this clear mandate, the implementation of public access policies has been uneven across federal agencies, with progress varying due to differences in resources, technical infrastructure, and agency-specific priorities. The 2022 OSTP Public Access Memorandum aims to accelerate agency efforts to enhance public access infrastructure and policies. This updated guidance presents an opportunity for agencies to not only meet immediate data-sharing requirements but also to expand policy scopes to include essential clinical data, such as biomarker data from clinical trials. To meet these goals, agencies should ensure that funding agreements explicitly require the publication of comprehensive biomarker data and that suitable repositories are available to store and share these critical datasets effectively.

Case Study: Project NextGen

A prime example of the potential success of such initiatives is Project NextGen, a program led by BARDA in collaboration with the NIH to advance the next generation of COVID-19 vaccines and treatments. As part of its vaccine program, Project NextGen includes centralized immunogenicity assays with the overarching goal of establishing correlates of protection, which could serve as surrogate biomarkers for next-gen vaccines. These assays are collected during Phase 2b vaccine studies sponsored by Project NextGen, which have been designed to measure a number of secondary immunogenicity endpoints including systemic and mucosal immune responses. Developers share their assays so that they can be used as a public good, in return for federal funding. This effort demonstrates the feasibility and benefits of a federally led effort to share assay data to advance biomarker validation and drug development. 

Recommendation 3. Create and Manage a Data Repository 

To enhance collaborative research and ensure the efficient use of publicly funded clinical data, we recommend establishing a secure data repository. This repository will serve as a centralized platform for data submission, storage, and access. Management of the repository could be undertaken by a federal agency, such as the NIH, leveraging their experience with the Biomarkers Consortium, perhaps in partnership with non-governmental organizations like the Biomarkers of Aging Consortium. Drawing from existing models, such as Project NextGen’s assay data management, can provide valuable insights into the implementation and operationalization of the repository. 

The cost of establishing and maintaining this repository, including data storage, management, and access controls, would be dwarfed by the socio-economic returns it could provide. This repository can facilitate data sharing, protect sensitive information, and promote a collaborative environment that accelerates biomarker validation and approval, while ensuring pharmaceutical companies that their hard-earned data is safely stored. 

The securely stored data in the repository would primarily be accessible to qualified researchers, clinicians, and policymakers involved in biomarker research and development, including academic researchers, pharmaceutical companies, and public health agencies. Access would be granted through an application and review process. The benefits of this repository are multifaceted: it accelerates research by providing a centralized database, enhances collaboration among scientists and institutions, increases efficiency by reducing redundancy and improving data management, ensures data security through robust access controls, offers cost-effectiveness with long-term socio-economic returns, and supports regulatory bodies with comprehensive data sets for more informed decision-making.

Recommendation 4. Create A Regulatory Pathway with Broader Application 

To accelerate the adoption of validated biomarkers and surrogate endpoints in drug development, we propose the creation of a streamlined regulatory approval process within the FDA. This new pathway would establish clear criteria and standardized procedures for biomarker evaluation and approval, facilitating their recognition for use across multiple products and therapeutic areas.

Currently, the FDA’s Center for Drug Evaluation and Research (CDER) operates the Biomarker Qualification Program (BQP), which allows drug developers to seek regulatory qualification for specific contexts of use. While this program fosters collaboration between the FDA and external stakeholders, biomarkers are qualified on a case-by-case basis, limiting their broader applicability across different drug development programs.

Additionally, the FDA maintains a Table of Surrogate Endpoints that have been used as the basis for drug approvals under the accelerated approval pathway. However, this table primarily serves as a reference and does not comprehensively address the need for a streamlined approval process for biomarkers and surrogate endpoints.

By developing a framework that moves away from traditional product-by-product assessments, the FDA could reduce existing barriers to biomarker and surrogate endpoint discovery and approval. This approach would encourage data sharing and collaboration among pharmaceutical companies and research institutions, leading to faster validation and broader acceptance of these critical tools in drug development.

This proposal builds upon existing legislative efforts, such as the 21st Century Cures Act of 2016, which includes provisions to accelerate medical product development and supports the use of biomarkers and surrogate endpoints in the regulatory process. Furthermore, it aligns with the FDA’s ongoing efforts to provide clarity on evidentiary criteria for biomarker qualification, as outlined in the 2018 guidance document “Biomarker Qualification: Evidentiary Framework.”

Inspiration for this approach can be drawn from the Advanced Approval Pathway for Longevity Medicines (AAPLM) proposed by the Alliance for Longevity Initiatives (See AAPLM-Whitepaper)​. The AAPLM includes provisions such as a special approval track, a priority review voucher system, and indication-by-indication patent term extensions, which align economic incentives with the transformative health improvements that longevity medicines can provide. These measures offer a valuable template for facilitating the recognition and approval of biomarkers. Adding to the existing FDA table of surrogate endpoints that can serve as the basis for drug approval or licensure, and referencing existing collaborations between the NIH and FDA, such as the Biomarkers Consortium, can provide a robust foundation for new biomarker evaluations. Ultimately, this regulatory innovation will support the development of life-saving drugs, enhance public health outcomes, and meaningfully contribute to economic growth by bringing effective treatments to market more quickly.

Conclusion

Today, over two thirds of all deaths in the United States are the result of an age-related condition. The burden of non-communicable diseases is growing, and better biomarkers and surrogate endpoints are needed to target diseases before they are life-threatening or debilitating. The next administration should implement a comprehensive framework to promote data sharing and incentivize the validation and regulatory approval of biomarkers and surrogate endpoints. This aligns directly with the administration’s goal to make Americans healthy. These solutions can substantially reduce the duration and cost of clinical trials, accelerate the development of life-saving drugs, and improve public health outcomes. It is possible and necessary to create an environment that encourages and rewards pharmaceutical companies to share crucial data that accelerates medical innovation. By discovering and validating predictive and responsive biomarkers of health and disease, new therapeutic classes can be developed to directly target biological aging and prevent most forms of cancers, heart disease, frailty, vulnerability to severe infection, and Alzheimer’s. This will enable the United States to remain at the forefront of medical research, and to respond to the growing demographic crisis of aging populations in declining health.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

Why should the federal government be the entity to act rather than the private sector?

A number of market failures stand in the way of the discovery and validation of predictive, reliable, and responsive biomarkers. First, it’s currently expensive to test drugs in multiple disease indications, which means pharmaceutical companies are often incentivized to focus on late-stage diseases (e.g. delaying death by a terminal cancer by three months), since this drug class is more easily and quickly trialed. The FDA also strongly assumes that a treatment ought to modulate a single outcome. (Think life/death; heart disease/no heart disease.) Therapeutics that target biological aging, for instance, would take decades to test without validated biomarkers or widely accepted surrogate endpoints.

Aging research, for instance, has seen a 70-fold increase in venture capital funding since the last decade. Yet so far—and this is a critical asterisk—misaligned commercial incentives have mostly optimized for unproven supplements, imprecise biological-age-tracking apps, and unsafe experimental therapies or cosmetics. The most well-meaning investors and founders in “longevity” often end up developing drugs for single disease indications (like osteoarthritis, or obesity) to avoid bankruptcy or as a path to self-fund their intent of developing drugs that more holistically target the mechanisms that drive aging. arket incentives need to be aligned to the pressing social needs these therapeutics could respond to.

The federal government is uniquely positioned to coordinate large-scale initiatives that require significant resources and regulatory oversight. While private sector companies play crucial roles in drug development, they often lack the incentives to self-coordinate and the authority to drive comprehensive data-sharing and biomarker validation efforts.

Cohesion from data-collection to regulatory approval of biomarkers is going to be key if surrogate endpoints are actually going to be adopted. Having the federal government oversee all stages will ensure this cohesion.

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You mention the Biomarkers Consortium. Why have they not succeeded in addressing this problem? How is your solution different?

The Biomarkers Consortium has made meaningful strides in advancing biomarker research, but they have not succeeded in acquiring sufficient data. The consortium relies on voluntary, precompetitive collaboration without providing strong financial or legislative incentives for data sharing. It does not maintain a centralized, secure data repository, and struggles with fragmented data sharing. It also lacks influence over the FDA’s biomarker qualification process, which remains complex and time-consuming. This has resulted in slow progress due to hesitancy from private entities to share valuable data. Our solution differs by directly addressing this data-sharing hurdle through a series of targeted incentives that reduce the case-by-case assessment currently required, and enable broader application of validated biomarkers across multiple drugs and therapeutic areas.

By introducing legislative changes to authorize patent extensions and expand Priority Review Vouchers (PRVs), we create compelling reasons for companies to share their data. Additionally, our proposal includes the development of a centralized data repository with a streamlined regulatory approval process, inspired by the Advanced Approval Pathway for Longevity Medicines (AAPLM). This approach not only incentivizes data sharing but also provides a clear and efficient pathway for biomarker validation and regulatory acceptance. By leveraging existing frameworks and offering tangible rewards, our solution proposes an increase in incentives, to match the socioeconomic benefits that may be unlocked by more accessibility to the wealth of existing but undersupplied biomedical data.

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The FDA already has an Accelerated Approval Pathway. Why do you need another pathway to validate biomarkers?

The FDA’s Accelerated Approval Pathway is indeed a valuable tool that allows for the approval of drugs based on surrogate endpoints that are reasonably likely to predict clinical benefit. This pathway requires substantial evidence showing that these surrogate endpoints are linked to clinical outcomes, usually gathered from rigorous clinical trials. However, it typically applies to surrogate endpoints validated for specific uses or products. Our goal is to establish a new pathway that supports the validation and use of surrogate endpoints across multiple products. By validating biomarkers that can be used across various drugs, we can streamline the drug development process, reducing the time and cost associated with bringing new therapies to market. This broader approach would enhance efficiency, reduce drug development time and costs, and promote innovation by encouraging pharmaceutical companies to invest in research, knowing that successful biomarkers can have wide-reaching applications.

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Who is likely to push back on this proposal, and how can that hurdle be overcome?

Pharmaceutical companies could push back on this proposal due to concerns over losing their competitive advantage by sharing proprietary data. They might reasonably fear that sharing valuable biomarker data could erode their market position and intellectual property. By involving pharmaceutical companies in the development of the proposal, we can better understand their concerns and tailor incentives accordingly. One effective strategy would be to offer significant financial incentives, such as Priority Review Vouchers (PRVs) or patent term extensions to companies that share their data. These incentives can offset the perceived risks and provide tangible benefits that make data sharing more attractive. By making PRVs transferable and offering additional incentives to small biotechnology companies, this policy can be implemented without overly favoring large pharmaceutical companies. Another possible strategy would be for the FDA to encourage drugs that target multiple disease indications at once, perhaps offering discounts or incentives for every extra biomarker or surrogate endpoint validated. Fostering a collaborative environment where the benefits of shared data (such as accelerated drug approvals and reduced R&D costs) are clearly communicated can reduce hurdles. Engaging economists to quantify the long-term economic gains to individual pharmaceutical companies as well as to society, while demonstrating how shared data can lead to industry-wide advancements, can further encourage participation. By providing competitive enough incentives, a framework can be created that balances the interests of pharmaceutical companies with the broader goal of advancing medical innovation and public health.

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What is the first step needed to get this proposal off the ground? Is there a pilot or scaled-back version of your proposal that could be advanced to start gaining traction and demonstrate proof of concept?

The first step to get this proposal off the ground is to introduce legislative changes that authorize patent extensions and expand the eligibility for Priority Review Vouchers (PRVs). These legislative changes will create the necessary incentives for pharmaceutical companies to participate in the program by offering tangible benefits that offset the risks associated with data sharing.

Simultaneously, developing and launching a pilot program for the centralized data repository is crucial. This pilot should focus on a specific subset of biomarkers for high-priority diseases and non-disease indications to demonstrate the feasibility and benefits of the proposed framework. By starting with a targeted approach, we can gather initial data, test the processes, and make any necessary adjustments before scaling up the program. This pilot will not only help in garnering support from stakeholders by showcasing the practical benefits of the framework but also refine the approach based on real-world feedback, ensuring a smoother and more effective broader implementation.

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What has doomed similar efforts in the past, and how will your proposal avoid those pitfalls?

Similar efforts in the past have often been hindered by a lack of incentives for data sharing and collaboration, along with fragmented regulatory processes. Our proposal aims to overcome these obstacles by introducing strong incentives which will encourage companies to share their data. Moreover, we propose creating a standardized regulatory pathway for biomarker approval, which will streamline the process and reduce fragmentation. By involving key federal agencies, we ensure a coordinated and comprehensive implementation, thus avoiding the pitfalls that have doomed past efforts.

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What justifies the recommended course of action for the policy’s implementation vs. other possible options?

The status quo is unacceptable. Millions of lives are lost or debilitated every year due to the slow and costly process of bringing new drugs to market, which is hindered by the lack of validated biomarkers and surrogate endpoints. The recommended course of action leverages existing regulatory frameworks and incentives that have proven effective in other contexts, such as the use of Priority Review Vouchers (PRVs) for neglected tropical diseases. By adapting these mechanisms to encourage data sharing and biomarker validation, we can build on established successes while addressing the specific challenges of the current drug development landscape.

This approach ensures that we utilize proven strategies to accelerate drug development and approval, reducing the overall time and cost associated with clinical trials. By fostering a collaborative environment and providing tangible incentives, we can significantly enhance the efficiency and effectiveness of the drug development process. This targeted strategy not only addresses the immediate needs but also sets a foundation for continuous improvement and innovation in the field of medical research, ultimately saving lives and improving public health outcomes.

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The next administration should establish a National Water Technology (Pipeline) to spur the innovation and commercialization of water technologies. The Pipeline should be designed to:

1. Proactively deploy broad-spectrum monitoring and treatment technologies nationwide to avoid the devastating societal impacts of water contaminants.
2. End significant sanitary sewer overflows that pose risks to human and environmental health.
3. Ensure that every community in America has access to affordable and safe drinking water.

A National Water Technology Pipeline would mobilize American entrepreneurs and manufacturers to lead on research and development of the next generation of solutions in water treatment, monitoring, and data management. The Pipeline would facilitate commercialization of later-stage water technologies by identifying innovative next-to-market solutions, proving technology through competitive demonstration projects, and deploying market-ready technology at full scale with federal funding support. An underlying objective of the Pipeline would be to improve water quality and access in the United States while addressing mounting infrastructure and maintenance costs. The Pipeline would also place an emphasis on training the next generation of technology-focused water professionals and strengthening community engagement and customer service.

Modernizing the water sector will require the federal government to renew its commitment to investing in water. In recent years, the water sector received only 4% of its funding from the federal government: a far lower fraction than other infrastructure sectors, such as highways (25%), mass transit and rail (23%), and aviation (45%). The funding injection from the Bipartisan Infrastructure Law (BIL) has provided a temporary step-change in federal investment, but the substantial gap in funding is still anticipated to grow. Increasing federal funding for water technology advancement even by a percentage point would have hugely beneficial impacts. By dedicating 1% of projected water infrastructure costs for a “good state of repair”—an estimated $12 billion over the next 10 years—the next administration can build a robust National Water Technology Pipeline, ushering in a new era of water and sanitation technologies. A similar scale of investment, $25 billion over 10 years for clean energy demonstrations, was authorized through BIL for the Department of Energy (DOE). 

Challenge and Opportunity 

The next administration will inherit water and wastewater infrastructure that the American Society of Civil Engineers has given a C- and D+ rating, respectively in 2021, which is essentially unchanged from the prior D and D+ rating in 2017. Much of the water and wastewater infrastructure across the United States is more than half a century old. These infrastructure assets are showing signs of significant deterioration and displaying strong risks of failure as they approach the end of their service lives. Put simply, many U.S. water systems are not equipped to handle emerging treatment requirements and increasing severe weather challenges.

We cannot address our nation’s water infrastructure crisis without addressing water infrastructure funding for modern systems. One problem is that federal water infrastructure funding has simply dried up. In the 1970s and early 1980s, federal funding accounted for 15–30% of water infrastructure funding nationwide. This fraction has recently declined to a baseline of only 4%, far lower than other infrastructure sectors. Municipalities have been forced to raise local water rates to cover the funding gap. Access to adequate supplies of clean water is quickly becoming unaffordable for many Americans as a result, and recent polls show that the percentage of voters who find their water service unaffordable is on the rise. The inadequacy of current investment in water is both perception and reality.  

A second problem is the growing cost of operating and maintaining water infrastructure. Nearly three-quarters of the public spending in the water sector supports operations and maintenance water systems, often legacy facilities. EPA conservatively estimates expenditures of $1.2 trillion over the next 20 years are needed just to maintain legacy drinking water ($625B) and wastewater ($630B) systems at current levels of service, without any modernization. Moreover, the U.S. water sector is large and complex, including over 50,000 community water systems and 16,000 sanitary sewer systems nationwide. Such a balkanized system makes it difficult to transfer innovative experiences and funding strategies across jurisdictional boundaries.

These challenges were exacerbated by the financial stresses and widespread supply chain challenges that the COVID-19 pandemic placed on municipalities. COVID-19 highlighted water treatment as an essential service. Serving as one of the most important tools we have for reducing the spread of infectious disease, clean water merits robust federal investment. COVID-19 also highlighted the usefulness of wastewater collection systems as early warning detection systems via wastewater-based epidemiology. Had there been investment in these wastewater based monitoring systems over the previous decade, the tracking of COVID-19 would have been significantly improved. The water industry is also vital to operations of other sectors essential to human health, environmental health, energy production, and transportation. Every dollar invested in drinking water and wastewater infrastructure increases GDP by $6.35, creates 1.6 new jobs, and provides $23 in public health-related benefits. Investing in the water sector is investing in the U.S. economy. The United States is lagging behind many other countries in dealing with issues as wide ranging as water-loss reduction, asset management, customer engagement, and customer service. It is past time to catch up.

The next administration should view these challenges as opportunities. Much has changed for the water sector in the last four years including the rise to prominence of artificial intelligence and machine learning capabilities, increased availability of low-cost sensors, widespread use of wastewater-based epidemiology as an early warning system for health risks, and rising challenge of malevolent cybersecurity threats from bad actors. Instead of propping up aging facilities, the next administration can incentivize investment into—and demonstration of—the most advanced and efficient water systems. Moreover, the next administration can incentivize the deployment of advanced monitoring and analytic technologies to proactively evaluate equipment health and develop a data-driven schedule for infrastructure replacement instead of ad hoc upgrades. The recent BIL funding provides an example of a historic $15B water infrastructure investment to replace lead pipes nationwide. While some innovative construction methods are being utilized, the water sector still lacks a suitable technology solution for the non-invasive identification of buried lead pipes, this is exactly the type of challenge a Technology Pipeline could address. Establishing a National Water Technology Pipeline will help unify our nation’s water sector and create pathways to expedite the installation of modern systems instead of maintaining outdated legacy technologies.

The next administration should empower the National Institute of Standards and Technology (NIST) in the Department of Commerce to lead this Pipeline development. (Isn’t the Environmental Protection Agency (EPA) in charge of water quality for the United States? See FAQs.) With the recent expansion of capabilities afforded by the CHIPS and Science Act, NIST is better positioned now more than ever to facilitate validation of new breakthroughs in low-cost sensors, data management and analytics, internet of things (IOT), predictive analysis, and machine learning and other technologies that are proving capable of significant productivity gains for water utilities and can prevent catastrophic system failures. As an example, modern sensor and data solutions have been demonstrated to reduce the historical challenge of sanitary sewer overflows by optimizing existing sewer networks. Further advances could even enable real-time monitoring of lead, per- and polyfluoroalkyl substances (PFAS), and other contaminants. Operational and maintenance savings realized from these technological solutions can be directly reinvested into infrastructure needs and/or used to subsidize water costs for low-income customers. The growth of the semiconductor manufacturing sector and water-intensive microchip facilities are also closely linked to water and wastewater infrastructure and NIST can play a part in driving those solutions. NIST can also engage in interagency initiatives with the DOE to address specific water-energy nexus challenges

Plan of Action

The next administration should set the United States on a path to build the most advanced water systems in the world by launching a new National Water Technology Pipeline initiative. The Pipeline would accelerate adoption of existing “market-ready” solutions from around the world while also fostering the development of next-generation technologies by American innovators. The Pipeline should be structured around three main goals:

1. Proactively deploying broad-spectrum monitoring and treatment technologies nationwide to avoid the devastating societal impacts of water contaminants.
2. Ending significant sanitary sewer overflows that pose risks to human and environmental health.
3. Ensuring that every community in America has access to affordable and safe drinking water.

Achieving these goals will require a multi-pronged approach, as described below.

New Public-Private Frameworks to Enable Innovation

NIST should lead a new collaborative effort aligned with the Department of Commerce’s mission to “promote U.S. innovation and industrial competitiveness” in the water sector. Specifically, NIST should partner with industry leaders from utilities, vendors, equipment manufacturers, and system designers to develop a unified framework for deploying new technologies in the water sector. The framework would include verification and provisional standards to allow utilities to more easily adopt new technologies and to open the market for private investment in public water infrastructure. These efforts could be modeled after NIST efforts on the Manufacturing USA program or DOE’s Office of Clean Energy Demonstrations (OCED). 

Technology Demonstration and Deployment Network

Congress should appropriate 1% of the projected total water infrastructure costs each year for the next 10 years to support water innovation. Specifically, these monies would be used for competitive grants (administered by NIST) to assist “early adopter” water utilities in deploying improved technologies, to fund state-based water innovation councils, and to support small manufacturers innovating in the water sector. NIST would coordinate with state, county, and local utilities, industry associations and professionals, and manufacturers to facilitate identification, testing, validation, and adoption of viable technology solutions. A similar development and dissemination strategy has successfully accelerated innovation in the transportation sector. NIST can also help lower risk associated with technology piloting by borrowing from the emerging piloting models in the water sector including the Isle Utilities “Trial Reservoirs” and WaterStart “CHANNELS” programs 

Education, Workforce, and Community Engagement

Innovation in theory cannot become innovation in practice without a well-trained, certified workforce to implement new solutions. Now more than ever, Americans are in need of well-paying jobs. A new water workforce will provide job opportunities in every county in the nation. The next administration can begin retraining workers into tech-savvy water professionals immediately through programs like the National Science Foundation’s Advanced Technological Education program and the Department of Defense’s SkillBridge program. 

Over the last three decades, the federal government has abdicated its responsibility for funding the water sector, leaving states and local utilities to tackle new treatment challenges, deal with the impacts of climate change, and overcome catastrophic events  like the COVID-19 pandemic. The next Administration can reinvest in U.S. water systems and bolster our economy by empowering NIST to spearhead a Pipeline to deliver modern solutions for modern water obstacles.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

How much would a National Water Technology Pipeline cost?

To meaningfully modernize U.S. water systems, the federal government should directly invest 1% of projected water infrastructure funding needs (about $12 billion over the next 10 years) into innovative water technology solutions. For comparison, recent investments into energy infrastructure such as DOE’s clean energy demonstrations have received $25 billion over the next 10 years. Federal spending on water infrastructure is nowhere near other peer infrastructure sectors and an order of magnitude lower than it is for the transportation sector.

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What is preventing technological progress in the water sector?

The water sector is strongly influenced by federal regulations that maintain minimum drinking-water and wastewater treatment standards. Where existing treatment standards can be met with legacy technologies, there is little incentive for utilities to invest in newer, advanced systems. Furthermore, evaluation and approval of new technologies typically occurs on a state-by-state basis, where differing state regulatory requirements inhibit the dissemination of successful solutions across jurisdictional boundaries. These barriers mean that useful new technologies can take as long as a decade to see widespread deployment in the water sector.

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How will an influx of federal funding for a National Water Technology Pipeline impact businesses in the water sector?

Funding support allocated through the Pipeline will de-risk investment by individual water utilities and enable those utilities to adopt new technologies and upgrade to newer systems more easily and efficiently. The uptake of new technologies will in turn increase demand for new water innovations, creating market opportunities for U.S. start-ups and entrepreneurs. Overall, the Pipeline will increase public health protections through deployment of advanced treatment systems and monitoring solutions while also attracting additional private investment in the water sector.

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How will this effort ensure safe drinking water for all Americans, especially equity for underserved communities?

The Pipeline will expedite development of new treatment technologies, monitoring systems, and cost-saving strategies, and will enable these solutions to be deployed at local utilities much more quickly. The Pipeline will support promising innovations and fund demonstration projects to increase the availability and visibility of vetted technology solutions for large and small utilities alike. Emphasis could and should be placed on accelerating technologies that solve challenges in rural communities, overburdened communities, communities with declining populations, and other underserved communities.

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Why have NIST in the Department of Commerce (DOC) serve as the lead federal agency for a National Water Technology Pipeline instead of EPA?

The Pipeline will require leadership and expertise from an agency focused on public-private partnerships and job creation. The DOC’s mission is “to promote job creation, economic growth, sustainable development, and improved living standards for all Americans by working in partnership with businesses, universities, communities, and workers.” NIST, within the DOC, is well positioned to support standards development, fund technology evaluations, support small manufacturers, and develop public-private partnership consortia. DOC would coordinate with EPA experts as needed to evaluate public health impacts and/or environmental compliance.

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EPA funds some water infrastructure projects through State Revolving Funds. Why not include this initiative in those programs?

The Clean Water and Drinking Water State Revolving Funds (SRFs) are designed to provide some funding directly to states – and then subsequently to utilities – to support local infrastructure projects through loans and grants. This process is not well suited for the funding of demonstration projects nor rapid sharing of solutions both regionally and nationally. The purpose of the Pipeline, by contrast, would be to identify new technologies that solve immediate and emerging broad challenges facing utilities across the nation, and to directly fund projects or consortia. Technologies identified through the Pipeline could ultimately be incorporated into SRF projects where appropriate.

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There is a crisis within healthcare technology research and development, wherein certain groups due to their age, gender, or race and ethnicity are under-researched in preclinical studies, under-represented in clinical trials, misunderstood by clinical practitioners, and harmed by biased medical technology. These issues in turn contribute to costly disparities in healthcare outcomes, leading to losses of $93 billion a year in excess medical-care costs, $42 billion a year in lost productivity, and $175 billion a year due to premature deaths. With the rise of artificial intelligence (AI) in healthcare, there’s a risk of encoding and recreating existing biases at scale.

The next Administration and Congress must act to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases. This will require coordinated effort across multiple agencies. In the development phase, science funding agencies should enforce mandatory subgroup analysis for diverse populations, expand funding for under-resourced research areas, and deploy targeted market-shaping mechanisms to incentivize fair technology. In the testing and regulation phase, the FDA should raise the threshold for evaluation of medical technologies and algorithms and expand data-auditing processes. In the market-deployment and evaluation phases, infrastructure should be developed to perform impact assessments of deployed technologies and government procurement should incentivize technologies that improve health outcomes.

Challenge and Opportunity

Bias is regrettably endemic in medical innovation. Drugs are incorrectly dosed to people assigned female at birth due to historical exclusion of women from clinical trials. Medical algorithms make healthcare decisions based on biased health data, clinically disputed race-based corrections, and/or model choices that exacerbate healthcare disparities. Much medical equipment is not accessible, thus violating the Americans with Disabilities Act. And drugs, devices, and algorithms are not designed with the lifespan in mind, impacting both children and the elderly. Biased studies, technology, and equipment inevitably produce disparate outcomes in U.S. healthcare.

The problem of bias in medical innovation manifests in multiple ways: cutting across technological sectors in clinical trials, pervading the commercialization pipeline, and impeding equitable access to critical healthcare advances.

Bias in medical innovation starts with clinical research and trials

The 1993 National Institutes of Health (NIH) Revitalization Act required federally funded clinical studies to (i) include women and racial minorities as participants, and (ii) break down results by sex and race or ethnicity. As of 2019, the NIH also requires inclusion of participants across the lifespan, including children and older adults. Yet a 2019 study found that only 13.4% of NIH-funded trials performed the mandatory subgroup analysis, and challenges in meeting diversity targets continue into 2024 . Moreover, the increasing share of industry-funded studies are not subject to Revitalization Act mandates for subgroup analysis. These studies frequently fail to report differences in outcomes by patient population as a result. New requirements for Diversity Action Plans (DAPs), mandated under the 2023 Food and Drug Omnibus Reform Act, will ensure drug and device sponsors think about enrollment of diverse populations in clinical trials. Yet, the FDA can still approve drugs and devices that are not in compliance with their proposed DAPs, raising questions around weak enforcement. 

The resulting disparities in clinical-trial representation are stark: African Americans represent 12% of the U.S. population but only 5% of clinical-trial participants, Hispanics make up 16% of the population but only 1% of clinical trial participants, and sex distribution in some trials is 67% male. Finally, many medical technologies approved prior to 1993 have not been reassessed for potential bias. One outcome of such inequitable representation is evident in drug dosing protocols: sex-aware prescribing guidelines exist for only a third of all drugs.

Bias in medical innovation is further perpetuated by weak regulation

Algorithms

Regulation of medical algorithms varies based on end application, as defined in the 21^st Century Cures Act. Only algorithms that (i) acquire and analyze medical data and (ii) could have adverse outcomes are subject to FDA regulation. Thus, clinical decision-support software (CDS) is not regulated even though these technologies make important clinical decisions in 90% of U.S. hospitals. The FDA has taken steps to try and clarify what CDS must be considered a medical device, although these actions have been heavily criticized by industry. Finally, the lack of regulatory frameworks for generative AI tools is leading to proliferation without oversight.

Even when a medical algorithm is regulated, regulation may occur through relatively permissive de novo pathways and 510(k) pathways. A de novo pathway is used for novel devices determined to be low to moderate risk, and thus subject to a lower burden of proof with respect to safety and equity. A 510(k) pathway can be used to approve a medical device exhibiting “substantial equivalence” to a previously approved device, i.e., it has the same intended use and/or same technological features. Different technical features can be approved so long as there are no questions raised around safety and effectiveness.

Medical algorithms approved through de novo pathways can be used as predicates for approval of devices through 510(k) pathways. Moreover, a device approved through a 510(k) pathway can remain on the market even if its predicate device was recalled. Widespread use of 510(k) approval pathways has generated a “collapsing building” phenomenon, wherein many technologies currently in use are based on failed predecessors. Indeed, 97% of devices recalled between 2008 to 2017 were approved via 510(k) clearance. 

While DAP implementation will likely improve these numbers, for the 692 AI-ML enabled medical devices, only 3.6% reported race or ethnicity, 18.4% reported age, and only .9% include any socioeconomic information. Further, less than half did detailed analysis of algorithmic performance and only 9% included information on post-market studies, raising the risk of algorithmic bias following approvals and broad commercialization.

Even more alarming is evidence showing that machine learning can further entrench medical inequities. Because machine learning medical algorithms are powered by data from past medical decision-making, which is rife with human error, these algorithms can perpetuate racial, gender, and economic bias. Even algorithms demonstrated to be ‘unbiased’ at the time of approval can evolve in biased ways over time, with little to no oversight from the FDA. As technological innovation progresses, especially generative AI tools, an intentional focus on this problem will be required.

Medical devices

Currently, the Medical Device User Fee Act requires the FDA to consider the least burdensome appropriate means for manufacturers to demonstrate the effectiveness of a medical device or to demonstrate a device’s substantial equivalence. This requirement was reinforced by the 21^st Century Cures Act, which also designated a category for “breakthrough devices” subject to far less-stringent data requirements. Such legislation shifts the burden of clinical data collection to physicians and researchers, who might discover bias years after FDA approval. This legislation also makes it difficult to require assessments on the differential impacts of technology.

Like medical algorithms, many medical devices are approved through 510(k) exemptions or de novo pathways. The FDA has taken steps since 2018 to increase requirements for 510(k) approval and ensure that Class III (high-risk) medical devices are subject to rigorous pre-market approval, but problems posed by equivalence and limited diversity requirements remain. 

Finally, while DAPs will be required for many devices seeking FDA approval, the recommended number of patients in device testing is shockingly low. For example, currently, only 10 people are required in a study of any new pulse oximeter’s efficacy and only 2 of those people need to be “darkly pigmented”. This requirement (i) does not have the statistical power necessary to detect differences between demographic groups, and (i) does not represent the composition of the U.S. population. The standard is currently under revision after immense external pressure. FDA-wide, there are no recommended guidelines for addressing human differences in device design, such as pigmentation, body size, age, and pre-existing conditions.

Pharmaceuticals

The 1993 Revitalization Act strictly governs clinical trials for pharmaceuticals and does not make recommendations for adequate sex or genetic diversity in preclinical research. The results are that a disproportionately high number of male animals are used in research and that only 5% of cell lines used for pharmaceutical research are of African descent. Programs like All of Us, an effort to build diverse health databases through data collection, are promising steps towards improving equity and representation in pharmaceutical research and development (R&D). But stronger enforcement is needed to ensure that preclinical data (which informs function in clinical trials) reflects the diversity of our nation. 

Bias in medical innovation are not tracked post-regulatory approval

FDA-regulated medical technologies appear trustworthy to clinicians, where the approval signals safety and effectiveness. So, when errors or biases occur (if they are even noticed), the practitioner may blame the patient for their lifestyle rather than the technology used for assessment. This in turn leads to worse clinical outcomes as a result of the care received.

Bias in pulse oximetry is the perfect case study of a well-trusted technology leading to significant patient harm. During the COVID-19 pandemic, many clinicians and patients were using oximeter technology for the first time and were not trained to spot factors, like melanin in the skin, that cause inaccurate measurements and impact patient care. Issues were largely not attributed to the device. This then leads to underreporting of adverse events to the FDA — which is already a problem due to the voluntary nature of adverse-event reporting. 

Even when problems are ultimately identified, the federal government is slow to respond. The pulse oximeter’s limitations in monitoring oxygenation levels across diverse skin tones was identified as early as the 1990s. 34 years later, despite repeated follow-up studies indicating biases, no manufacturer has incorporated skin-tone-adjusted calibration algorithms into pulse oximeters. It required the large Sjoding study, and the media coverage it garnered around delayed care and unnecessary deaths, for the FDA to issue a safety communication and begin reviewing the regulation.

Other areas of HHS are stepping up to address issues of bias in deployed technologies. A new ruling by the HHS Office of Civil Rights (OCR) on Section 1557 of the Affordable Care Act requires covered providers and institutions (i.e. any receiving federal funding) to identify their use of patient care decision support tools that directly measure race, color, national origin, sex, age, or disability, and to make reasonable efforts to mitigate the risk of discrimination from their use of these tools. Implementation of this rule will depend on OCR’s enforcement, and yet it provides another route to address bias in algorithmic tools.

Differential access to medical innovation is a form of bias

Americans face wildly different levels of access to new medical innovations. As many new innovations have high cost points, these drugs, devices, and algorithms exist outside the price range of many patients, smaller healthcare institutions and federally funded healthcare service providers, including the Veterans Health Administration, federally qualified health centers and the Indian Health Service. Emerging care-delivery strategies might not be covered by Medicare and Medicaid, meaning that patients insured by CMS cannot access the most cutting-edge treatments. Finally, the shift to digital health, spurred by COVID-19, has compromised access to healthcare in rural communities without reliable broadband access. 

Finally, the Advanced Research Projects Agency for Health (ARPA-H) has a commitment to have all programs and projects consider equity in their design. To fulfill ARPA-H’s commitment, there is a need for action to ensure that medical technologies are developed fairly, tested with rigor, deployed safely, and made affordable and accessible to everyone.

Plan of Action

The next Administration should launch “Healthcare Innovation for All Americans” (HIAA), a whole of government initiative to improve health outcomes by ensuring Americans have access to bias-free medical technologies. Through a comprehensive approach that addresses bias in all medical technology sectors, at all stages of the commercialization pipeline, and in all geographies, the initiative will strive to ensure the medical-innovation ecosystem works for all. HIAA should be a joint mandate of Health and Human Services (HHS) and the Office of Science Technology and Policy (OSTP) to work with federal agencies on priorities of equity, non-discrimination per Section 1557 of the Affordable Care Act and increasing access to medical innovation, and initiative leadership should sit at both HHS and OSTP. 

This initiative will require involvement of multiple federal agencies, as summarized in the table below. Additional detail is provided in the subsequent sections describing how the federal government can mitigate bias in the development phase; testing, regulation, and approval phases; and market deployment and evaluation phases.

Three guiding principles should underlie the initiative:

1. Equity and non-discrimination should drive action. Actions should seek to improve the health of those who have been historically excluded from medical research and development. We should design standards that repair past exclusion and prevent future exclusion. 
2. Coordination and cooperation are necessary. The executive and legislative branches must collaborate to address the full scope of the problem of bias in medical technology, from federal processes to new regulations. Legislative leadership should task the Government Accountability Office (GAO) to engage in ongoing assessment of progress towards the goal of achieving bias-free and fair medical innovation.
3. Transparent, evidence-based decision making is paramount. There is abundant peer-reviewed literature that examines bias in drugs, devices, and algorithms used in healthcare settings — this literature should form the basis of a non-discrimination approach to medical innovation. Gaps in evidence should be focused on through deployed research funding. Moreover, as algorithms become ubiquitous in medicine, every effort should be made to ensure that these algorithms are trained on representative data of those experiencing a given healthcare condition.

Agency	Role
Advanced Research Projects Agency for Health (ARPA-H)	ARPA-H has committed to tackling health equity in biomedical research, and to aligning each project it undertakes with that goal. As such, ARPA-H should lead the charge in developing processes for equity in medical technology — from idea conceptualization to large-scale rollout — and serve as a model for other federally funded healthcare programs.
National Institute of Health (NIH)	NIH should fund research that addresses health-data gaps, investigates algorithmic and data bias, and assesses bias embedded in medical technical tools. Simultaneously, NIH should create standards for diversity in samples and/or datasets for preclinical research. Finally, NIH must strongly enforce the 1993 NIH Revitalization Act’s diversity provisions.
National Science Foundation (NSF)	NSF should collaborate with NIH on cross-agency programs that fund R&D specific to mitigating bias of technologies like AI.
Food and Drug Administration (FDA)	FDA should take a more active role in uncovering bias in medical innovation, given its role as a regulatory checkpoint for all new medical technologies. This should include more rigorous evaluation protocols as well as better tracking of emergent bias in medical technologies post-approval.
Assistant Secretary for Technology Policy (ASTP)	ASTP publishes standards for effective use of healthcare information technology that ensure quality care delivery. Their standards-setting should offer solutions for compliance with Section 1557 for novel AI/ML algorithms.
Centers for Medicare and Medicaid (CMS)	CMS oversees the coordination of coverage, coding, and payment processes with respect to new technologies and procedures. Thus, CMS should focus on ensuring all new technologies developed through federal funding, like those that will be built by ARPA-H and its industry partners, are covered by Medicare and Medicaid. In addition, CMS and its accrediting partners can require compliance with federal regulatory standards, which should be extended to assess medical technologies. Finally, CMS should assess how flawed medical technologies are being used to decide on medical care provision, and update guidelines.
Federal Trade Commission (FTC)	FTC should protect America’s medical technology consumers by auditing high-risk medical innovations, such as decision-making algorithms.
Agency for Healthcare Research and Quality (AHRQ)	The AHRQ, a component of HHS, should identify areas where technology bias is leading to disparate healthcare outcomes and report its findings to Congress, the White House, and agency leaders for immediate action.
Centers for Disease Control and Prevention (CDC)	CDC’s expertise in health-data collection should be mobilized to identify research and development gaps.
Department of Commerce (DOC)	Given its role in enforcing U.S. trade laws and regulations, DOC can do much to incentivize equity in medical device design and delivery. The National Institute of Standards and Technology (NIST) should play a key role in crafting standards for identifying and managing bias across key medical-technology sectors.
Department of Education (ED)	ED should work with medical schools to develop and implement learning standards and curricula on bias in medical technology.
Department of Defense (DOD)	DOD has formalized relationships with FDA to expedite medical products useful to American military personnel. As a DOD priority is to expand diversity and inclusion in the armed forces, these medical products should be assessed for bias that limits safety and efficacy.
Health Resources and Services Administration (HRSA)	HRSA should coordinate with federally qualified health centers on digital health technologies, taking advantage of the broadband expansion outlined in the Bipartisan Infrastructure Bill.
Veterans Affairs (VA) and the Veterans Health Administration (VHA)	The VA should work with ARPA-H and its industry partners to establish cost-effective rollout of new innovations to VA-run hospitals. VA should also use its procurement power to require diversity in the clinical trials of the drugs, devices, and algorithms it procures. VA could also use prize challenges to spur innovation.
Government Accountability Office (GAO)	The GAO should prepare a comprehensive roadmap for addressing bias endemic to the cycle of medical technology development, testing, and deployment, with a focus on mitigating bias in “black box” algorithms used in medical technology.
Office of Management and Budget (OMB)	OMB should work with HIAA leadership to design a budget for HIAA implementation, including for R&D funding, personnel for programmatic expansion, data collectives, education, and regulatory enforcement.
Office of Science Technology and Policy (OSTP)	OSTP should develop processes and standards for ensuring that individual rights are not violated by biased medical technologies. This work can build on the AI Bill of Rights Initiative.

Addressing bias at the development phase

The following actions should be taken to address bias in medical technology at the innovation phase:

• Enforce parity in government-funded research. For clinical research, NIH should examine the widespread lack of adherence to regulations requiring that government funded clinical trials report sex, racial or ethnicity, and age breakdown of trial participants. Funding should be reevaluated for non-compliant trials. For preclinical research, NIH should require gender parity in animal models and representation of diverse cell lines used in federally funded studies.

• Deploy funding to address research gaps. Where data sources for historically marginalized people are lacking, such as for women’s cardiovascular health, NIH should deploy strategic, targeted funding programs to fill these knowledge gaps. This could build on efforts like the Initiative on Women’s Health Research. Increased funding should include resources for underrepresented groups to participate in research and clinical trials through building capacity in community organizations. Results should be added to a publicly available database so they can be accessed by designers of new technologies. Funding programs should also be created to fill gaps in technology, such as in diagnostics and treatments for high-prevalence and high-burden uterine diseases like endometriosis (found in 10% of reproductive-aged people with uteruses).      

• Invest in research into healthcare algorithms and databases. Given the explosion of algorithms in healthcare decision-making, NIH and NSF should launch a new research program focused on the study, evaluation, and application of algorithms in healthcare delivery, and on how artificial intelligence and machine learning (AI/ML) can exacerbate healthcare inequities. The initial request for proposals should focus on design strategies for medical algorithms that mitigate bias from data or model choices.

• Task ARPA-H with developing metrics for equitable medical technology development. ARPA-H should prioritize developing a set of procedures and metrics for equitable development of medical technology. Once developed, these processes should be rapidly deployed across ARPA-H, as well as published for potential adoption by additional federal agencies, industry, and other stakeholders. ARPA-H could also collaborate with NIST on standards setting with NIST and ASTP on relevant standards setting. For instance, NIST has developed an AI Risk Management Framework and the ONC engages in setting standards that achieve equity by design. CMS could use resultant standards for Medicare and Medicaid reimbursements.

• Leverage procurement as a demand-signal for medical technologies that work for diverse populations. As the nation’s largest healthcare system, the Veterans Health Administration (VHA) can generate demand-signals for bias-free medical technologies through its procurement processes and market-shaping mechanisms. For example, the VA could put out a call for a pulse oximeter that works equally well across the entire range of human skin pigmentation and offer contracts for the winning technology.

Addressing bias at the testing, regulation, and approval phases

The following actions should be taken to address bias in medical innovation at the testing, regulation, and approval phases:

• Raise the threshold for FDA evaluation of devices and algorithms. Equivalency necessary to receive 510(k) clearance should be narrowed. For algorithms, this would involve consideration of whether the datasets for machine learning tactics used by the new device and its predicate are similar. For devices (including those that use algorithms), this would require tightening the definition of “same intended use” (currently defined as a technology having the same functionality as one previously approved by the FDA) as well as eliminating the approval of new devices with “different technological characteristics” (the application of one technology to a new area of treatment in which that technology is untested). 

• Evaluate FDA’s guidance on specific technology groups for equity. Requirements for the safety of a given drug, medical device, or algorithm should have the statistical power necessary to detect differences between demographic groups and represent all end-users of the technology..

• Establish a data bank for auditing medical algorithms. The newly established Office of Digital Transformation within the FDA should create a “data bank” of healthcare images and datasets representative of the U.S. population, which could be done in partnership with the All of Us program. Medical technology developers could use the data bank to assess the performance of medical algorithms across patient populations. Regulators could use the data bank to ground claims made by those submitting a technology for FDA approval.

• Allow data submitted to the FDA to be examined by the broader scientific community. Currently, data submitted to the FDA as part of its regulatory-approval process is kept as a trade secret and not released pre-authorization to researchers. Releasing the data via an FDA-invited “peer review” step in the regulation of high-risk technologies, like automated decision-making algorithms, Class III medical devices, and drugs, will ensure that additional, external rigor is applied to the technologies that could cause the most harm due to potential biases.

• Establish an enforceable AI Bill of Rights. The federal government and Congress should create protections for necessary uses of artificial intelligence (AI) identified by OSTP. Federally funded healthcare centers, like facilities part of the Veterans Health Administration, could refuse to buy software or technology products that violate this “AI Bill of Rights” through changes to federal acquisition regulation (FAR).

Addressing bias at the market deployment and evaluation phases 

• Strengthen reporting mechanisms at the FDA. Healthcare providers, who are often closest to the deployment of medical technologies, should be made mandatory reporters to the FDA of all witnessed adverse events related to bias in medical technology. In addition, the FDA should require the inclusion of unique device identifiers (UDIs) in adverse-response reporting. Using this data, Congress should create a national and publicly accessible registry that uses UDIs to track post-market medical outcomes and safety. 

• Require impact assessments of deployed technologies. Congress must establish systems of accountability for medical technologies, like algorithms, that can evolve over time. Such work could be done by passing the Algorithmic Accountability Act which would require companies that create “high-risk automated decision systems” to conduct impact assessments reviewed by the FTC as frequently as necessary. 

• Assess disparities in patient outcomes to direct technical auditing. AHRQ should be given the funding needed to fully investigate patient-outcome disparities that could be caused by biases in medical technology, such as its investigation into the impacts of healthcare algorithms on racial and ethnic disparities. The results of this research should be used to identify technologies that the FDA should audit post-market for efficacy or the FTC should investigate. CMS and its accrediting agencies can monitor these technologies and assess whether they should receive Medicare and Medicaid funding. 

• Review reimbursement guidelines that are dependent on medical technologies with known bias. CMS should review its national coverage determinations for technologies, like pulse oximetry, that are known to perform differently across populations. For example, pulse oximeters can be used to determine home oxygen therapy provision, thus potentially excluding darkly-pigmented populations from receiving this benefit.

• Train physicians to identify bias in medical technologies and identify new areas of specialization. ED should work with medical schools to develop curricula training physicians to identify potential sources of bias in medical technologies and ensuring that physicians understand how to report adverse events to the FDA. In addition, ED should consider working with the American Medical Association to create new medical specialties that work at the intersection of technology and care delivery.

• Ensure that technologies developed by ARPA-H have an enforceable access plan. ARPA-H will produce cutting-edge technologies that must be made accessible to all Americans. ARPA-H should collaborate with the Center for Medicare and Medicaid Innovation to develop strategies for equitable delivery of these new technologies. A cost-effective deployment strategy must be identified to service federally-funded healthcare institutions like Veterans Health Administration hospitals and clinical, federally qualified health centers, and Indian Health Service.

• Create a fund to support digital health technology infrastructure in rural hospitals. To capitalize on the $65 billion expansion of broadband access allocated in the Bipartisan Infrastructure Bill, HRSA should deploy strategic funding to federally qualified health centers and rural health clinics to support digital health strategies — such as telehealth and mobile health monitoring —  and patient education for technology adoption.

A comprehensive road map is needed

The GAO should conduct a comprehensive investigation of “black box” medical technologies utilizing algorithms that are not transparent to end users, medical providers, and patients. The investigation should inform a national strategic plan for equity and non-discrimination in medical innovation that relies heavily on algorithmic decision-making. The plan should include identification of noteworthy medical technologies leading to differential healthcare outcomes, creation of enforceable regulatory standards, development of new sources of research funding to address knowledge gaps, development of enforcement mechanisms for bias reporting, and ongoing assessment of equity goals.

Timeline for action

Realizing HIAA will require mobilization of federal funding, introduction of regulation and legislation, and coordination of stakeholders from federal agencies, industry, healthcare providers, and researchers around a common goal of mitigating bias in medical technology. Such an initiative will be a multi-year undertaking and require funding to enact R&D expenditures, expand data capacity, assess enforcement impacts, create educational materials, and deploy personnel to staff all the above.

Near-term steps that can be taken to launch HIAA include issuing a public request for information, gathering stakeholders, engaging the public and relevant communities in conversation, and preparing a report outlining the roadmap to accomplishing the policies outlined in this memo.

Conclusion

Medical innovation is central to the delivery of high-quality healthcare in the United States. Ensuring equitable healthcare for all Americans requires ensuring that medical innovation is equitable across all sectors, phases, and geographies. Through a bold and comprehensive initiative, the next Administration can ensure that our nation continues leading the world in medical innovation while crafting a future where healthcare delivery works for all.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

How will the success of HIAA be evaluated?

HIAA will be successful when medical policies, projects, and technologies yield equitable health care access, treatment, and outcomes. For instance, success would yield the following outcomes:

• Representation in preclinical and clinical research equivalent to the incidence of a studied condition in the general population.


• Research on a disease condition funded equally per affected patient.


• Existence of data for all populations facing a given disease condition.


• Medical algorithms that have equal efficacy across subgroup populations.


• Technologies that work equally well in testing as they do when deployed to the market.


• Healthcare technologies made available and affordable to all care facilities.

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Why does this memo propose an expansive multi-agency effort instead of just targeting the FDA?

Regulation alone cannot close the disparity gap. There are notable gaps in preclinical and clinical research data for women, people of color, and other historically underrepresented groups that need to be filled. There are also historical biases encoded in AI/ML decision making algorithms that need to be studied and rectified. In addition, the FDA’s role is to serve as a safety check on new technologies — the agency has limited oversight over technologies once they are out on the market due to the voluntary nature of adverse reporting mechanisms. This means that agencies like the FTC and CMS need to be mobilized to audit high-risk technologies once they reach the market. Eliminating bias in medical technology is only possible through coordination and cooperation of federal agencies with each other as well as with partners in the medical device industry, the pharmaceutical industry, academic research, and medical care delivery.

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What challenges might the Administration encounter from industry in launching this initiative?

A significant focus of the medical device and pharmaceutical industries is reducing the time to market for new medical devices and drugs. Imposing additional requirements for subgroup analysis and equitable use as part of the approval process could work against this objective. On the other hand, ensuring equitable use during the development and approval stages of commercialization will ultimately be less costly than dealing with a future recall or a loss of Medicare or Medicaid eligibility if discriminatory outcomes are discovered.

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Is there bipartisan support to secure the funding for this initiative?

Healthcare disparities exist in every state in America and are costing billions a year in economic growth. Some of the most vulnerable people live in rural areas, where they are less likely to receive high-quality care because costs of new medical technologies are too high for the federally qualified health centers that serve one in five rural residents as well as rural hospitals. Furthermore, during continued use, a biased device creates adverse healthcare outcomes that cost taxpayers money. A technology functioning poorly due to bias can be expensive to replace. It is economically imperative to ensure technology works as expected, as it leads to more effective healthcare and thus healthier people.

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To help protect U.S. critical infrastructure workers from future pandemics and other biological threats, the next presidential administration should use the federal government’s grantmaking power to ensure ample supplies of high-quality respiratory personal protective equipment (PPE). The administration can take five concrete actions:

1. The Office of Pandemic Preparedness and Response Policy (OPPR) can coordinate requirements for federal agencies and recipients of federal emergency/disaster preparedness funding to maintain access to at least one reusable respirator per critical employee.
2. The Department of Labor’s Occupational Safety and Health Administration (OSHA) can initiate an occupational safety rule on reusable respirator resilience caches.
3. The Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR) can require PPE manufacturers receiving federal funding to demonstrate their robustness to extreme pandemics.
4. ASPR’s Strategic National Stockpile can start stockpiling reusable respirators.
5. The Federal Emergency Management Agency (FEMA) can leverage its public outreach experience to increase “peacetime” adoption of reusable respirators.

These actions would complete the Biden Administration’s existing portfolio of efforts to reduce the likelihood of dangerous PPE shortages in the future, reaffirming executive commitment to protecting vulnerable workers, building a resilient national supply chain, and encouraging innovation.

Challenge and Opportunity

The next pandemic could strike at any time, and our PPE supply chain is not ready. Experts predict that the chance of a severe natural epidemic could perhaps triple in the next few decades, and advances in synthetic biology are increasing the risk of deliberate biological threats. As the world witnessed in 2020, disposable PPE can quickly become scarce in a crisis. Inadequate stockpiles left millions of workers with insufficient access to respiratory protection and often higher death rates than the general public—especially the critical infrastructure workers who operate the supply chains for our food, healthcare, public safety, and other essential goods and services. In future pandemics, which could have a 4% to 11%+ chance of occurring in the next 20 years based on historical extrapolations, PPE shortages could cause unnecessary infections, deaths, and burnout among critical infrastructure workers.

Figure 1. Notional figure from Blueprint Biosecurity’s Next-Gen PPE Blueprint demonstrating the need for stockpiling PPE in advance of future pandemics.

Recognizing the vulnerability of our PPE supply chain to future pandemics, Section 3.3 of the National Biodefense Strategy and Implementation Plan directs the federal government to:

Establish resilient and scalable supply and manufacturing capabilities for PPE in the United States that can: (a) enable a containment response for; and (b) meet U.S. peak projected demand for healthcare and other essential critical infrastructure workers during a nationally or internationally significant biological incident.

At a high level, securing the supply of PPE during crises is already understood as a national priority. However, despite the federal government’s past efforts to invest in domestic PPE manufacturing, production capacity will still take time to ramp up in future scenarios. Our current stockpiles aren’t large enough to bridge that gap. Some illustrative math: there are approximately 50 million essential workers in the United States, but as of 2022 our Strategic National Stockpile only had about 540 million disposable N95 respirators. This is barely enough to last 10 days, assuming each worker only uses one per day. (One per day is even a stretch: extended use and reuse of disposable N95s often leads to air leakage around wearers’ faces.) State- and local-level stockpiles may help, but many states have already started jettisoning their PPE stocks as purchases from 2020 expire and the prudence of paying for storage becomes less visible. PPE shortages may happen again.

Fortunately, there is existing technology that can reduce the likelihood of shortages while also protecting workers better and reducing costs: reusable respirators, like elastomeric half-mask respirators (EHMRs). 

A single EHMR typically costs between $20 and $40. While the up-front cost of an EHMR is higher than the ~$1 cost of a disposable N95, a single EHMR can reliably last a worker for thousands of shifts over the entirety of a pandemic. Compared to disposable N95s, EHMRs are also better at protecting workers from infection, and workers prefer them to disposable N95s in risky environments. EHMR facepieces often have a 10-year shelf life, and filter cartridges typically have the same five-year shelf life of a typical disposable N95. A supply of EHMRs also takes up an estimated 1.5% of the warehouse space of the equivalent supply of disposable N95s.

Figure 2. The relative size of equivalent PPE stockpiles. Source: Blueprint Biosecurity’s Next-Gen PPE Blueprint.

Some previous drawbacks of EHMRs were their lack of filtration for exhaled air and the unclear efficacy of disinfecting them between uses. Both of those problems are on their way to being solved. The newest generation of EHMRs on the market (products like the Dentec Comfort-Air Nx and the ElastoMaskPro) provide filtration on both inhalation and exhalation, and initial results from ongoing studies presented by the National Institute for Occupational Safety and Health (NIOSH) have demonstrated that they can be safely disinfected. (Product links are for illustrative purposes, not endorsement.)

Establishing stable demand for the newest generation of EHMRs could drive additional innovation in product design or material use. This innovation could further reduce worker infection rates by eliminating the need for respirator fit testing, improving comfort and communication, and enabling self-disinfection. It could also increase the number of critical infrastructure workers coverable with a fixed stockpile budget by increasing shelf lives and reducing cost per unit. Making reusable respirators more protective, ergonomic, and storable would improve the number of lives they are able to save in future pandemics while lowering costs. For further information on EHMRs, the National Academies has published studies that explore the benefits of reusable respirators.

The next administration, led by the new OPPR can require critical infrastructure operators that receive federal emergency/disaster preparedness funding to maintain resilience caches of at least one reusable respirator per critical infrastructure worker in their workplaces—enough to protect those workers during future pandemics.

These resilience caches would have two key benefits:

1. Because many U.S. critical infrastructure operators, from healthcare to electricity providers, receive federal emergency preparedness funds, these requirements would bolster our nation’s mission-critical functions against pandemics or other inhalation hazards like wildfire smoke. At the same time, the requirements would be tied to a source of funding that could be used to meet them. 
2. By creating large, sustainable private-sector demand for domestic respirators, these requirements would help substantially grow the domestic industrial base for PPE manufacturing, without relying on future warm-basing payments like those that Congress recently rescinded.

By taking action, the next administration has an opportunity to reduce the future burden on taxpayers and the federal government, help keep workers safe, and increase the robustness of domestic critical infrastructure.

Plan of Action

Recommendation 1. Require federal agencies and recipients of federal emergency/disaster preparedness funding to maintain access to at least one reusable respirator per critical employee.

OPPR can coordinate a process to define the minimum target product profile of reusable respirators that employers must procure. To incentivize continual respirator innovation, OPPR’s process can regularly raise the minimum performance standards of PPE in these resilience caches. These standards could be published alongside regular PPE demand forecasts. As products expire every 5 or 10 years, employers would be required to procure the new, higher standard. 

OPPR can also convene representatives from each agency that administers emergency/disaster preparedness funding programs to critical infrastructure sectors and can align those agencies on language for:

• Requiring funding recipients to maintain access to resilience caches of enough PPE.
• Explicitly including “maintaining access to PPE resilience caches” as an acceptable and encouraged use of funding.

The Cybersecurity and Infrastructure Security Agency (CISA) within the Department of Homeland Security (DHS) can update its definition of essential workers and set guidelines for which employees would need a reusable respirator.

FEMA’s Office of National Continuity Programs can recommend reusable respirator stocks for critical staff at federal departments and agencies, and the Centers for Medicare and Medicaid Services (CMS) can also set a requirement for healthcare facilities as a condition of participation for receiving Medicare reimbursement.

Recommendation 2. Initiate an occupational safety rule on reusable respirator resilience caches.

To cover any critical infrastructure workplaces that are not affected by the requirements in Recommendation 1, OSHA can also require employers to maintain these resilience caches. This provision could be incorporated into a broader rule on pandemic preparedness, as a former OSHA director has suggested.

OSHA should also develop preemptive guidance on the scenarios in which it would likely relax its other rules. In normal times, employers are usually required to implement a full, costly Respiratory Protection Program (RPP) whenever they hand an employee an EHMR. An RPP typically includes complex, time-consuming steps like medical evaluations that may impede PPE access in crises. OSHA already has experience relaxing RPP rules in pandemics, and preemptive guidance on when those rules might be relaxed in the future would help employers better understand possible regulations around using their resilience caches.

Recommendation 3. Require PPE manufacturers receiving federal funding to demonstrate their robustness to extreme pandemics.

The DHS pandemic response plan notes that workplace absenteeism rates during extreme pandemics are projected to be to 40%. 

U.S. PPE manufacturers supported by federal industrial base expansion programs, such as the investments managed by ASPR, should be required to demonstrate that they can remain operational in extreme conditions in order to continue receiving funding. 

To demonstrate their pandemic preparedness, these manufacturers should have:

• An on-site stockpile of enough reusable respirators for the maximum number of workers they might hire during a manufacturing surge.
• A comprehensive pandemic response plan that addresses workplace transmission protection.
• Regular exercises and independent evaluations of their pandemic response plans.

Recommendation 4. Start stockpiling reusable respirators in the Strategic National Stockpile.

Inside ASPR, the Strategic National Stockpile should ensure that the majority of its new PPE purchases are for reusable respirators, not disposable N95s. The stockpile can also encourage further innovation by making advance market commitments for next-generation reusable respirators.

Recommendation 5. Leverage FEMA’s public outreach experience to increase “peacetime” adoption of reusable respirators.

To complement work on growing reusable respirator stockpiles and hardening manufacturing, FEMA can also help familiarize the workforce with these products in advance of a crisis. FEMA can use Ready.gov to encourage the general public to adopt reusable respirators in household emergency preparedness kits. It can also develop partnerships with professional groups like the American Industrial Hygiene Association (AIHA) or the Association for Health Care Resource & Materials Management (AHRMM) to introduce workers to reusable respirators and instruct them in their use cases during both business as usual and crises.

Conclusion

Given the high and growing risk of another pandemic, ensuring that we have an ample supply of highly protective respiratory PPE should be a national priority. With new reusable respirators hitting the market, the momentum around pandemic preparedness after the COVID-19 pandemic, and a clear opportunity to reaffirm prior commitments, the time is ripe for the next administration to make sure our workers are safe the next time a pandemic strikes.

This action-ready policy memo is part of Day One 2025 — our effort to bring forward bold policy ideas, grounded in science and evidence, that can tackle the country’s biggest challenges and bring us closer to the prosperous, equitable and safe future that we all hope for whoever takes office in 2025 and beyond.

PLEASE NOTE (February 2025): Since publication several government websites have been taken offline. We apologize for any broken links to once accessible public data.

Frequently Asked Questions

Are critical infrastructure workers interested in using reusable respirators?

Yes. Throughout COVID-19, critical infrastructure worker unions have consistently advocated for EHMRs. Examples include the New York State Nurses Association (NYSNA) and the Service Employees International Union (SEIU) 121rn.

Unions have also been at the forefront of broader calls for securing PPE access in future pandemics; the California Nurses Association was the driving force behind California’s most recent PPE stockpiling laws.

Studies have also shown that workers prefer reusable respirators to disposable N95s in risky environments.

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Will these requirements increase costs for employers?

Not in the long run. As a single employee infection can cost $340 per day, it is more cost-effective for most employers to spend around $3 per critical employee per year for reusable respirators. For hospitals in states like California or New York, which mandate one- to three-month PPE stockpiles, switching those stockpiles to reusable respirators would likely be cost-saving, as demonstrated by past case studies. Most of these hospitals are still meeting those requirements with disposable N95s largely because of slow product choice re-evaluation cycles.

Managing these resilience caches would also pose a minimal burden on employers. Most EHMRs can be comfortably stored in most indoor workplaces, taking up around the volume of a large coffee mug for each employee. Small workplaces with fewer than 50 employees could likely fit their entire resilience cache in a cardboard box in a back closet, and large workplaces will likely already have systems for managing emergency products that expire, like AEDs, first-aid kits, and fire extinguishers. As with other consumables like printer ink cartridges, PPE manufacturers can send reminders to employers when the products they purchased are about to expire.

To put this into perspective, fire alarm units should generally be replaced every 10 years for $20 to $30 each, and typically require new batteries once or twice per year. We readily accept the burden and minor cost of fire alarm maintenance, even though all U.S. fire deaths in the last 10 years only accumulate to 3% of COVID-19’s U.S. death toll.

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What about workers who can’t wear EHMRs?

While EHMRs fit most workers, there may be some workers who aren’t able to wear them due to religious norms or assistive devices.

Those workers can instead wear another type of reusable respirator, powered air-purifying respirators (PAPRs). While PAPRs are even more effective at keeping workers safe than EHMRs, they cost significantly more and can be very loud. Employers and government stockpiles can include a small amount of PAPRs for those workers who can’t wear EHMRs, and can encourage eventual cost reductions and user-experience improvements with advance market commitments and incremental increases in procurement standards.

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Aren’t physical stockpiles inefficient?

Yes, but they reduce the risk of any lags in PPE access. Every day that workers are exposed to pathogens without adequate PPE, their likelihood of infection goes up. Any unnecessary exposures speed the spread of the pandemic. Also, PPE manufacturing ramp-up could be slowed by employee absences due to infection or caring for infected loved ones.

To accommodate some employers’ reluctance to build physical stockpiles, the administration can enable employers to satisfy the resilience cache requirement in multiple ways, such as:

• On-site resilience caches in their workplaces


• Agreements with distributors to manage resilience cache inventory as a rotating supply bubble


• Agreements with third-party resilience cache managers


• Purchase options with manufacturers that have demonstrated enough capacity to rapidly manufacture resilience cache inventory at the start of a pandemic

Purchase options would function like a “virtual” resilience cache: they would incentivize manufacturers to build extra warm-base surge capacity and test their ability to rapidly ramp up manufacturing pace. However, it would increase the risk that workers will be exposed to infectious disease hazards before their PPE arrives. (Especially in the case of a severe pandemic, where logistics systems could get disrupted.)

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Would these resilience caches be usable for any other hazards besides pandemics?

Yes. Employers could use respirators from their resilience cache to protect workers from localized incidents like seasonal flu outbreaks, wildfires, or smog days, and put them back into storage when they’re no longer needed.

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Could this be expanded to other pandemic hardening activities, beyond PPE?

Yes. Federal emergency/disaster preparedness funding could be tied to other requirements, like:

• Installing the capacity to turn up workplace air ventilation or filtration significantly


• Maintaining and regularly exercising pandemic response protocols


• Investing in passive transmission suppression technology (e.g., germicidal ultraviolet light)

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How might these requirements affect post-emergency PPE spending?

The next time there’s a pandemic, having these requirements in place could help ensure that any post-emergency funding (e.g., Hazard Mitigation Assistance Program grants) will be spent on innovative PPE that aligns with the federal government’s broader PPE supply chain strategies.

If the Strategic National Stockpile receives additional post-emergency funding from Congress, it could also align its purchases with the target product profiles that critical infrastructure operators are already procuring to.

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Science is advancing at an unprecedented speed, and scientists are facing major ethical dilemmas daily. Unfortunately, the general public rarely gets opportunities to share their opinions and thoughts on these ethical challenges, moving us, as a society, towards a future that is not inclusive of most people’s ideas and beliefs. Scientists regularly call for public engagement opportunities to discuss cutting-edge research. In fact, “71% of scientists [associated with the American Association for the Advancement of Science (AAAS)] believe the public has either some or a lot of interest in their specialty area.” Sadly, scientists’ calls often go unnoticed and unanswered, as there continue to be inadequate mechanisms for these engagement opportunities to come to fruition.

To Deliberate or Not to Deliberate

Public deliberation, when performed well, can lead to more transparency, accountability to the public, and the emergence of ideas that would otherwise go unnoticed. Due to the direct involvement of participants from the public, decisions made through such initiatives can also be seen as more legitimate. On a societal level, public deliberation has been shown to encourage pluralism among participants.

Despite the importance of deliberation, it’s important to note that it is not always the best way to engage the public. Planning a public deliberation event — a citizens’ panel, for instance — takes a large amount of time and resources. Plus, incentivizing a random sample of citizens to participate (which is considered the gold standard of deliberation) is difficult. It’s therefore paramount to first assess whether the topic of focus is suitable for public deliberation. 

To assess the appropriateness of a deliberation topic, consider the following criteria (inspired by criteria set forth by Stephanie Solomon and Julia Abelson and the Kettering Foundation):

1. Does the issue involve conflicting public opinions? Issues that involve setting priorities in healthcare, for example, may benefit from public deliberation as there is no singular correct answer; deliberation may offer a more clear and holistic view of what is best for a community, according to the community.
2. Is the issue controversial? If so, deliberation can be a good tool as it brings many opinions into view and can foster pluralism as mentioned previously.
3. Does the issue have no clear-cut solution and is “intractable, ongoing, or systemic”?
4. Do all available solutions have significant drawbacks?
5. Does the community at large have an interest in the problem?
6. Would the discussion of the issue benefit from a combination of expert and real-world experience and knowledge (what Solomon and Abelson call “hybrid” topics)? Certain issues may solely require technical knowledge but many issues would benefit from the views of the public as well.¹
7. Are citizens and the government on the same page about the issue? If not, public deliberation can foster trust, but only if the initiative is done with the intention of taking the public’s conclusions into account.

Setting Goals

If it’s deemed that the topic is suitable for public deliberation, the next step is to set goals for the public deliberation initiative. Julia Abelson, Lead of the Public Engagement in Health Policy Project and Professor at McMaster University, has explained that one of the significant differentiating factors between successful and unsuccessful initiatives is thoughtful planning and organization — including setting clear goals and objectives organizers would like to meet by the end of deliberation. Having an end goal not only helps with planning but also allows for a realistic goal to be shared with deliberation participants. Setting unrealistic expectations as to what the deliberation process is meant to achieve — and subsequently not achieving those goals — will lead participants and citizens, in general, to lose trust in the deliberation process (and organizational body).

Is the goal of deliberation to bring new ideas into view and share those with relevant agencies (governmental or otherwise)? Is the goal instead to enact change in current policies? Is the goal to help shape new policies? The aforementioned Citizens’ Reference Panel on Health Technologies in Canada did not directly impact the government’s decisions, but served to make experts aware of a viewpoint they had not previously explored. This is in contrast to the typical “sit and listen” initiatives that don’t have as much of a capacity to encourage new ideas to emerge. In another instance, a citizens’ jury in Buckinghamshire, England was formed to discuss how to tackle back pain in the county. The Buckinghamshire Health Authority promised to implement the citizens’ recommendations (as was mandated by a charity that was supporting this public deliberation effort) — and they did.

Expanding on the idea of making promises and accountability, it’s important for the organizing body — which may or may not include a federal agency — to consider its role in implementing the conclusions of the deliberation. Promising to implement the conclusion of the deliberations can serve to invigorate discussion and make participants more engaged, knowing that their discussions can have a direct impact on future decisions. For instance, the British Columbia Biobank Deliberation involved a “commitment at the outset of the deliberation from the leaders of a proposed BC BioLibrary (now funded by the Michael Smith Foundation for Health Research) that the Bio-Library’s policy discussions would consider suggestions from this deliberation.” Researchers have suggested this may have contributed to participants’ interest in the deliberation event. Despite some examples of implementation following deliberation (such as the Buckinghamshire and Ontario examples), there continues to be a lack of adequate change based on the public’s recommendations. One other instance comes from NASA’s 2014 efforts to involve the public in the discussion around planetary defense (in the context of asteroids) through a participatory technology assessment (PTA). It seems that the PTA helped to spur the creation of NASA’s Planetary Defense Coordination Office. 

Furthermore, providing updates on implementation to participants, and the public at large, would provide another crucial aspect of accountability: “explanations and justifications.” However, these updates on their own would not fulfill an organization or agency’s duty to accountability as that requires an active dialogue with the public (which is precisely why implementing the conclusions of public deliberation initiatives is important).  

When to Deliberate: Agenda Setting for Citizens

As mentioned above, deliberation can happen at various points during the policymaking pipeline. It has become increasingly popular to include the public early on in the process, such as in an agenda-setting role. This allows the public not only to engage in discussions about a topic but to also set the priorities and frame how the discussions will move forward. As Naomi Scheinerman writes, “with proper agenda setting and precedent creation, the resulting […] questions would be more reflective of what the public is interested in discussing rather than of the companies, industries, and other stakeholder groups.”

A trailblazing model in citizen agenda-setting has been the Ostbelgien Model. The model involves both a permanent Citizens’ Council and ad hoc Citizens’ Panels. Though the members of the Citizens’ Council rotate (and are chosen randomly), one of the permanent roles of the Council is to select topics for the ad hoc Citizens’ Panels, with citizens having a direct hand in what issues their fellow citizens and government should tackle. Since its inception in 2019, the Citizens’ Council has asked Citizens’ Panels to tackle issues such as “how to improve the working conditions of healthcare workers” and “inclusive education.” 

Framing

One of the pillars of the success of public deliberation is a well-scoped question that is framed appropriately. Issues that are framed unfairly, meaning they place emphasis on a specific part of the issue while ignoring others, can lead to inaccurate results and a loss of trust between the public and the organizers. Though this depends on the goals of the deliberation, it’s often best for questions to be specific in their scope to allow for concrete results at the end of the deliberation initiative. For example, an online deliberation session in New York City aimed to assess the public’s views on who should be given priority access to COVID-19 vaccines. One of the questions asked participants to rank the order in which they think a pre-specified list of essential workers should get access to the vaccine. This allows for discussion while retaining a clear focus.

Another example comes from climate change. Climate change can be framed in many ways —  through an economic frame, a public health frame, a justice frame, and others. These various framings impact how the public reacts to the issue; in the case of the economic frame, it has led to “political divisiveness.” Focusing instead on the public health frame, for instance, led to greater agreement on policy decisions. Similarly, according to a 2023 policy paper from the Organisation for Economic Co-operation and Development (OECD), an issue like COVID-19 can be less polarizing if the framing used is about solutions to the pandemic rather than solely vaccines. Importantly, the organizers of the public deliberation initiative do not have sole control over the framing of the issue. Citizens often have a pre-existing “frame of thought.” This makes frames tricky yet essential in making it possible to appropriately and productively deliberate a topic. 

Framing is implicit in that participants in deliberation are not aware of it, making it all the more crucial to be wary of the framing. Thus, it becomes clear how seemingly unimportant factors, such as setting, also affect deliberation. According to Mauro Barisione, the framing of the setting includes:

• Who is promoting the event and who the sponsors are: Whether the public trusts the promoters/sponsors and the feelings they associate with them (including any explicit views the sponsors promote) may impact the framing of the topic at hand.
• Where is/are the deliberative session(s) being held “(i.e., institutional, academic, civil society or business organization, etc.)”: Apart from accessibility concerns, the location of the deliberative session(s) sends implicit messages to participants who may have previously had negative experiences at governmental institutions, for instance.
• Who are the witnesses and experts brought on as part of the project: This point is most obvious. Especially when it comes to less well-known topics, witnesses and experts may be the first window into a new topic for participants. A biased selection of experts (or including experts who provide unscientific evidence) can significantly impact deliberation. Moreover, an oft-neglected point worth considering is the diversity of expert witnesses who present relevant information at public deliberation events. Selecting experts is discussed in more detail in a later section, but it’s worth noting here that a diverse group of expert presenters will ensure a diversity of views and may aid in building trust with participants as well. 

Selecting a Type of Public Deliberation

Another factor that merits attention at this point is the type of public deliberation being undertaken. Though public deliberation has been referred to as one entity thus far, there are many different types, including, but not limited to, citizens’ juries, planning cells, consensus conferences, citizens’ assemblies, and deliberative polls. Below are some further details about various types of public deliberation (where a source is not included below, it was adapted from Smith & Setälä).

Citizens’ juries

• Description: “In common with the legal jury, citizens’ jury assumes that a small group of ordinary people, without special training, is willing and able to take important decisions in the public interest” (Coote & Mattinson)
  • Selected jurists are meant to represent a microcosm of their community (Crosby)
  • Jurors are selected through a quota process that often takes into account demographics (e.g., age, gender, education and race) or jurors’ prior opinions about the question at hand (Crosby)
  • Neutral moderator moderates discussions (Crosby)
  • Jurors are able to determine what questions are asked of the witnesses
  • Similar to planning cells (below), jurors are paid for the time (e.g., $75 per day)
• Number of participants: 12–24
• Time: 2-4 days (Armour)
• Output: Jurors put together a written report of their conclusions (Armour)
• Examples: Ned Crosby of the independent Jefferson Institute in the US initially ran them with groups of 12-24 people (Smith & Wales)
  • Another example is the Oregon Citizens’ Initiative Review

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Planning cells

• Description: Deliberation includes 3 phases (Participedia):
  • Citizens are presented with pertinent information from multiple perspectives and ask clarifying questions
    • Often two cells are run in parallel, one starting an hour later than the other so that expert witnesses can present information twice within one visit (Dienel)
    • Two trained moderators are required for each planning cell (Dienel)
  • Cells are broken up into smaller groups of 5 and work together to come up with recommendations regarding the topic
  • The full cell reconvenes and each mini group presents their top recommendation, which is then assessed by all members of the group, until some final recommendations are made
• Number of participants: 25 in each cell (multiple cells running simultaneously or one after another); often have 6-10 planning cells total (Dienel)
• Time: 3-4 days (Dienel)
  • Each day is split into four chunks of time, each spent on a different “thematic focus”
  • The final day is used to summarize the participants’ thoughts and come to conclusions (Planning Cells Database)
• Output: Citizens’ report
  • Created by the planning committee based on quantitative data aggregated from all the cells (for instance, from how participants responded to which option they favored) (Dienel)
  • The first draft of the report may also be discussed with participants in a follow-up meeting
• Example: Cologne Town Square

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Consensus conferences/citizens’ conferences

• Description: These conferences have been described as a citizens’ jury plus a town hall meeting (Einsiedel & Eastlick)
  • Citizens learn some basic facts about the issue at hand and formulate questions they’d like addressed (Kenyon). In other words, the topic is chosen by the organizers while the concrete problems are selected by the citizens (Nielsen et al.).
  • Witnesses are called to answer these questions (Kenyon) and the experts are selected entirely by citizens (Nielsen et al.)
  • A steering group is often involved who ensures that “the conference is balanced and just” and provides support to the organizers (Nielsen et al.)
    • Members include “scientists, representatives of non-governmental organizations, policy-makers and others, who are engaged and informed concerning the topic”
  • It’s recommended that fact sheets be prepared that explain basic definitions necessary for understanding the topic as well as pros and cons for all sides — this will be provided to participants in preparation for discussions and the questioning of expert witnesses (Nielsen et al.)
    • Introductory materials should also clearly explain the role of the consensus conference participants and how their contributions will be used to inform future decisions
• Number of participants: 10-24
• Time: 4 days
• Output: Report written by citizen participants (Kenyon)
• Example: Danish Board of Technology consensus conferences

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Citizens’ assemblies

• Description: Typically larger and longer than the deliberative processes discussed above, similar to legislatures composed of regular citizens (Lacelle-Webster & Warren)
  • Organizers often aim to make assemblies as representative of the public as possible through methods like stratified random sampling (Lacelle-Webster & Warren)
  • More limited participation opportunities so some suggest that it’s better to call citizens’ assemblies “representative institutions” rather than a form of participatory democracy (Lacelle-Webster & Warren)
  • Participants compensated for their time (Ferejohn)
  • Based on the initial citizens’ assembly in British Columbia, any interested expert witnesses or groups were able to testify in front of the participants (Ferejohn)
  • Participants can ask any questions of the witnesses (Ferejohn)
  • A Chair — who was the only public official directly involved in the process — is able to make obligatory rulings as to how the deliberations would proceed
  • Organizers set the agenda
  • Formats can vary: the inaugural 2004 British Columbia citizens’ assembly was more so in the format of a legislature as opposed to an Irish citizens’ assembly which included roundtable discussions with groups of 7-8 participants alongside a facilitator and notetaker at each table (Farrell et al.)
• Number of participants: 99-150
• Time: Meetings over several months (often during weekends) (Farrell et al.)
• Output: Report and recommendations from citizens’ assembly (Ferejohn)
• Example: The 2004 British Columbia Citizens’ Assembly

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Deliberative polls

• Description: Combines traditional polling with the benefits of participatory processes
  • Randomly selected participants are polled on their opinions about a topic (Stanford Deliberative Democracy Lab)
  • Participants receive introductory materials about the issue prior to the event (Stanford Deliberative Democracy Lab)
  • A weekend-long event where participants learn more about the issues from experts (ask questions from experts) and discuss issues with one another with trained facilitators present (Stanford Deliberative Democracy Lab)
  • At the end, complete the questionnaire from earlier once more (Stanford Deliberative Democracy Lab)
  • Participants often paid for their time ($75-$200) (Participedia)
• Number of participants: 200+
• Time: One weekend (Stanford Deliberative Democracy Lab)
• Output: Differences measured between the opinions of participants pre- and post-deliberative polling process (Stanford Deliberative Democracy Lab)
• Example: 2008 deliberative poll on housing shortages in San Mateo County, California

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A note on online deliberation

The COVID-19 pandemic forced many initiatives to shift to a fully online modality. This highlighted many of the opportunities as well as challenges that online deliberation presents. One consideration is accessibility, a double-edged sword when it comes to deliberation. Virtual deliberation alleviates the need for a venue or hotel accommodations — decreasing costs for organizers — and may allow participants to continue to go to work at the same time. However, difficulties with using technology and a lack of access to a device or an internet connection are drawbacks. Another opportunity presented by virtual deliberation is to provide more balanced viewpoints on the topic of deliberation. For instance, there are no geographical barriers as to the experts organizers can invite to speak at an event. 

A concern somewhat unique to online deliberation is data privacy and security. While this can also be an issue with in-person initiatives, many tools that participants are familiar with and may prefer to use do not have robust security.

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A note on cost

While the cost of many deliberation initiatives is not publicly available, the available estimates range from $20,000 (citizens’ jury) to $95,000 (consensus conference) to $2.6 million (Europe-wide deliberative poll of 4300 people) to $5.5 million (citizens’ assembly). Note that these costs come from a range of time points and locations (though they have been adjusted for inflation) and only serve as rough estimates. A major contributor to these costs, particularly for longer deliberative initiatives, is hotel or venue costs as well as the reimbursement of participants. This reimbursement is costly but a part of the founding philosophy of many types of deliberation, including that of planning cells.

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Selecting Participants

Many different approaches can be taken to selecting participants for deliberative forums. Unfortunately, there are inherent trade-offs in selecting a sampling method or approach. For instance, random sampling is more in line with the principle of “equal opportunity” and may promote “cognitive diversity”— the diversity of ideas, experiences, and approaches participants bring to the event — but is prone to creating deliberation groups that are not representative of the population at large. This is particularly true when the deliberative forum has few participants. This is why, depending on the type of deliberation event (and therefore number of participants chosen), a different type of sampling may be appropriate. 

Another approach is random-stratified sampling, where participants are randomly chosen and invited to participate in the deliberative event. There is often an unequal distribution among those who accept the invitation — for instance, individuals with higher socio-economic statuses may respond disproportionately more. In this case, a more representative sample may be chosen from those who responded. Quotas may also be set, such as ensuring that a certain number of female-identifying participants are included in a deliberative event. For this method, the organizers must decide on groups of individuals who are primarily affected by the topic being discussed, as well as groups often excluded from such deliberations. A deliberative forum on immigration, for instance, may call for the presence of a participant who is an immigrant to ensure polarization does not take place. In certain instances, purposive sampling — where individuals from groups whose views are specifically being sought are purposefully chosen — may also be appropriate. Furthermore, some researchers suggest including a “critical mass” of individuals from typically underserved groups. This can serve to make participants more comfortable in speaking up, ensure that the diversity of discussions is retained when participants are broken up into smaller groups (in certain forms of public deliberation), and provide a step in avoiding tokenism.

Furthermore, there are newer methods of selecting participants that combine both random and stratified sampling — namely algorithms that try to maximize both representation and equal opportunity of participation. One instance is the LEXIMIN algorithm which “choose[s] representative panels while selecting individuals with probabilities as close to equal as mathematically possible.” This algorithm is open-access and can be used at panelot.org. 

Aside from considerations for selecting participants, it’s important to consider the selected individuals’ ability and willingness to participate. Several factors can dissuade selected individuals from taking part, including but not limited to, the cost of missing work, the cost of childcare, transportation costs, and lack of trust in the organizing body or agency. Prohibitive costs are addressed by several of the deliberation models discussed in the “Selecting a Type of Public Deliberation” section. These models strongly suggest stipends which, at minimum, cover incidental expenses. A lack of trust is a particularly important issue to address as it can hinder the organizer’s ability to reach individuals typically left out of policymaking discussions. One approach to addressing this once again brings us to making — and critically, keeping — promises regarding the implementation of the conclusions of participants. Framing (as discussed in an earlier section) can also contribute to building trust, though, importantly, this is not a gap that can be bridged overnight. A more extensive discussion on inclusion in public deliberation forums can be found here.

Bringing On Experts & Creating Materials

Prior to selecting the group who will participate in the public deliberation activity, steps need to be taken to organize which experts will be part of the event and create the informational material that will be provided to participants before deliberations begin. 

Here, efforts must be made to ensure sufficient and balanced information is presented without creating a framing event where participants enter discussions with a biased perspective. It has been found that participants readily integrate the facts and opinions presented by experts/witnesses prior to deliberation and critically engage with their points. A deliberative engagement initiative in British Columbia, Canada about biobanking brought on a variety of experts and stakeholders to present to participants. To ensure fairness, presenters were “given specific topics, limited presentation times, and asked to use terms as defined in the information booklet” that was previously provided. A unique component included in this initiative was the ability for participants to ask presenters questions in between the two deliberative session weekends, which were two weeks apart, through a website. 

In addition, participants were provided with booklets and readings. In the case of the British Columbia initiative, to create booklets and background materials, a literature review was performed. Once more, the materials should provide a balance of opinions. They should include the most important facts relevant to the question at hand, some of the most common/salient approaches and points with regards to the question, and the weaknesses of each approach/point (Mauro Barisione). It is also best to keep materials succinct, with some deliberative initiatives keeping their materials to one page long.

Though the traditional approach is to have experts present prior to deliberation, other methods have also been used. For instance, a Colorado deliberation initiative focused on future water supply used an “on tap but not on top” expert approach. Rather than call experts to present information, they instead provided one-page information sheets, followed directly by deliberation. Experts were present during the deliberation session. When prompted by a participant, a facilitator would ask an expert to briefly join the group to answer the participant’s question. The approach was largely successful, though one “rogue expert” frequently interjected in a group’s discussion, providing his own opinions. One limiting factor to this approach is time; the deliberative sessions mentioned above were two hours long. But many other forms of deliberation are significantly longer, making coordinating with experts for long durations of time difficult. Despite these challenges, this approach provides an interesting way of integrating experts into the deliberation process so their expertise is best used and the participants’ questions are best answered as they arise.

Facilitation

A good facilitator or moderator is critical to the deliberation process. As explained by Kara N. Dillard, moderators set the ground rules for the discussion and prevent any one participant from dominating the session; this is called presentation. It has been found that clearly setting expectations for the discussion can lead to greater deliberative functioning — which, for our purposes, includes the exchange of ideas/reasons, equality, and freedom to speak and be heard — according to participants. Moderators also guide the discussion in two main ways: asking questions that challenge what participants have already discussed (elicitation); and connecting ideas that were previously brought up to new topics and “play[ing] devil’s advocate” to bring forth new ideas (interpretation). At the end of the session, moderators also help participants produce conclusions by asking what areas of consensus and contention were present throughout the discussion.

Moderators can take multiple approaches to facilitating, with one framework proposed by Kara N. Dillard separating moderators into three groups: passive, moderate, and involved. Passive moderators take a “backseat” approach to moderating. They often describe their role to participants as only being there to prevent a participant from dominating the conversation, rather than actively leading it. This has led to unfocused discussions and unclear conclusions. Participants often jumped around and went off-topic. Though this passive approach may work in some instances, a moderate or involved approach often leads to better deliberation.

Involved facilitators actively lead the discussion by asking questions that challenge participants to think in new ways, sometimes acting as a “quasi-participant.” In line with this, these moderators often play devil’s advocate to move the discussion in new, albeit related, directions. These moderators ask follow-up questions and “editorialize” to help participants flesh out their ideas together and aim to pinpoint points of contention so participants can further discuss them. If participants begin to veer off-topic, involved moderators will move the group back into a more focused direction while also connecting this new topic to the main question, allowing for new thoughts to emerge. These moderators take the time to sum up the main points brought up by participants after each point so conclusions become clear. Once more, this approach may not work in all instances but often leads to deeper conversations and more focused conclusions.

As implied by the name, moderate facilitators are somewhere in between passive and involved facilitators. These moderators ask questions to guide the discussion, but don’t often challenge the participants and let them take the wheel. These moderators use the elicitation strategy frequently, an important difference between moderate and passive moderators.

Due to the skills needed to facilitate a deliberation event well, organizers or government agencies looking to organize these events may require would-be facilitators to undergo brief training. 

What Comes Next

After deliberation has taken place, the next step is to write a report summarizing the conclusions of the deliberative forum. As we have seen several times with other topics, there are multiple approaches to this. One approach is to leave the report writing to the facilitators, organizers, or researchers who use their own takeaways from the deliberation (in the case of facilitators) or summarize based on recordings or transcripts (in the case of organizers or researchers). However, this method introduces bias into the process and doesn’t allow participants to be directly involved in creating conclusions or next steps.

An alternative is to allocate time towards coming up with conclusions together with participants both throughout and at the end of the deliberative session. Recall that involved facilitators frequently summarize the conclusions of the group throughout the deliberation, making this final task both more efficient and more participant-led. Participants can directly and immediately add on to or push back against the facilitator’s summary. As a guideline, Public Agenda, an organization conducting public engagement research, divides the summary into the following sections: areas of agreement, areas of disagreement, questions requiring further research, and high-priority action steps.