Unpacking Hiring: Toward a Regional Federal Talent Strategy

Government, like all institutions, runs on people. We need more people with the right skills and expertise for the many critical roles that public agencies are hiring for today. Yet hiring talent in the federal government is a longstanding challenge. The next Administration should unpack hiring strategy from headquarters and launch a series of large scale, cross-agency recruitment and hiring surges throughout the country, reflecting the reality that 85% of federal employees are outside the Beltway. With a collaborative, cross-agency lens and a commitment to engaging jobseekers where they live, the government can enhance its ability to attract talent while underscoring to Americans that the federal government is not a distant authority but rather a stakeholder in their communities that offers credible opportunities to serve. 

Challenge and Opportunity

The Federal Government’s hiring needs—already severe across many mission-critical occupations—are likely to remain acute as federal retirements continue, the labor market remains tight, and mission needs continue to grow. Unfortunately, federal hiring is misaligned with how most people approach job seeking. Most Americans search for employment in a geographically bounded way, a trend which has accelerated following the labor market disruptions of the COVID-19 pandemic. In contrast, federal agencies tend to engage with jobseekers in a manner siloed to a single agency and across a wide variety of professions. 

The result is that the federal government tends to hire agency by agency while casting a wide geographic net, which limits its ability to build deep and direct relationships with talent providers, while also duplicating searches for similar roles across agencies. Instead, the next Administration should align with jobseekers’ expectations by recruiting across agencies within each geography. 

By embracing a new approach, the government can begin to develop a more coordinated cross-agency employer profile within regions with significant federal presence, while still leveraging its scale by aggregating hiring needs across agencies. This approach would build upon the important hiring reforms advanced under the Biden-Harris Administration, including cross-agency pooled hiring, renewed attention to hiring experience for jobseekers, and new investments to unlock the federal government’s regional presence through elevation of the Federal Executive Board (FEB) program. FEBs are cross-agency councils of senior appointees and civil servants in regions of significant federal presence across the country. They are empowered to identify areas for cross-agency cooperation and are singularly positioned to collaborate to pool talent needs and represent the federal government in communities across the country.

Plan of Action

The next Administration should embrace a cross-agency, regionally-focused recruitment strategy and bring federal career opportunities closer to Americans through a series of 2-3 large scale, cross-agency recruitment and hiring pilots in geographies outside of Washington, DC. To be effective, this effort will need both sponsorship from senior leaders at the center of government, as well as ownership from frontline leaders who can build relationships on the ground. 

Recommendation 1. Provide Strategic Direction from the Center of Government 

The Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) should launch a small team, composed of leaders in recruitment, personnel policy and workforce data, to identify promising localities for coordinated regional hiring surges. They should leverage centralized workforce data or data from Human Capital Operating Plan workforce plans to identify prospective hiring needs by government-wide and agency-specific mission-critical occupations (MCOs) by FEB region, while ensuring that agency and sub-agency workforce plans consistently specify where hiring will occur in the future. They might also consider seasonal or cyclical cross-agency hiring needs for inclusion in the pilot to facilitate year-to-year experimentation and analysis. With this information, they should engage the FEB Center of Operations and jointly select 2-3 FEB regions outside of the capital where there are significant overlapping needs in MCOs. 

As this pilot moves forward, it is imperative that OMB and OPM empower on-the-ground federal leaders to drive surge hiring and equip them with flexible hiring authorities where needed. 

Recommendation 2. Empower Frontline Leadership from the FEBs

FEB field staff are well positioned to play a coordinating role to help drive surges, starting by convening agency leadership in their regions to validate hiring needs and make amendments as necessary. Together, they should set a reasonable, measurable goal for surge hiring in the coming year that reflects both total need and headline MCOs (e.g., “in the next 12 months, federal agencies in greater Columbus will hire 750 new employees, including 75 HR Specialists, 45 Data Scientists, and 110 Engineers”). 

To begin to develop a regional talent strategy, the FEB should form a small task force drawn from standout hiring managers and HR professionals, and then begin to develop a stakeholder map of key educational institutions and civic partners with access to talent pools in the region, sharing existing relationships and building new ones. The FEB should bring these external partners together to socialize shared needs and listen to their impressions of federal career opportunities in the region.

With these insights, the project team should announce publicly the number and types of roles needed and prepare sharp public-facing collateral that foregrounds headline MCOs and raises the profile of local federal agencies. In support, OPM should launch regional USAJOBS skins (e.g., “Columbus.USAJOBS.gov”) to make it easy to explore available positions. The team should make sustained, targeted outreach at local educational institutions aligned with hiring needs, so all federal agencies are on graduates’ and administrators’ radar. 

These activities should build toward one or more signature large, in-person, cross-agency recruitment and hiring fairs, perhaps headlined by a high profile Administration leader. Candidates should be able to come to an event, learn what it means to hold a job in their discipline in federal service, and apply live for roles at multiple agencies, all while exploring what else the federal government has to offer and building tangible relationships with federal recruiters. Ahead of the event, the project team should work with agencies to align their hiring cycles so the maximum number of jobs are open at the time of the event, potentially launching a pooled hiring action to coincide. The project team should capture all interested jobseekers from the event to seed the new Talent Campaigns function in USAStaffing that enables agencies to bucket tranches of qualified jobseekers for future sourcing. 

Recommendation 3. Replicate and Celebrate

Following each regional surge, the center of government and frontline teams should collaborate to distill key learnings and conclude the sprint engagement by developing a playbook for regional recruitment surges. Especially successful surges will also present an opportunity to spotlight excellence in recruitment and hiring, which is rarely celebrated. 

The center of government team should also identify geographies with effective relationships between agencies and talent providers for key roles and leverage the growing use of remote work and location negotiable positions to site certain roles in “friendly” labor markets. 

Conclusion

Regional, cross-agency hiring surges are an opportunity for federal agencies to fill high-need roles across the country in a manner that is proactive and collaborative, rather than responsive and competitive. They would aim to facilitate a new level of information sharing between the frontline and the center of government, and inform agency strategic planning efforts, allowing headquarters to better understand the realities of recruitment and hiring on the ground. They would enable OPM and OMB to reach, engage, and empower frontline HR specialists and hiring managers who are sufficiently numerous and fragmented that they are difficult to reach in the present course of business. 

Finally, engaging regionally will emphasize that most of the federal workforce resides outside of Washington, D.C., and build understanding and respect for the work of federal public servants in communities across the nation.

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.

Extreme Heat and Wildfire Smoke: Consequences for Communities

More Extreme Weather Leads to More Public Health Emergencies

Extreme heat and wildfire smoke both pose significant and worsening public health threats in the United States. Extreme heat causes the premature deaths of an estimated 10,000 people in the U.S. each year, while more frequent and widespread wildfire smoke exposure has set back decades of progress on air quality in many states. Importantly, these two hazards are related: extreme heat can worsen and prolong wildfire risk, which can increase smoke exposure. 

Extreme heat and wildfire smoke events are independently becoming more frequent and severe, but what is overlooked is that they are often occurring in the same place at the same time. Emerging research suggests that the combined impact of these hazards may be worse than the sum of their individual impacts. These combined impacts have the potential to put additional pressure on already overburdened healthcare systems, public budgets, and vulnerable communities. Failing to account for these combined impacts could leave communities unprepared for these extreme weather events in 2025 and beyond.

To ensure resilience and improve public health outcomes for all, policymakers should consider the intersection of wildfire smoke and extreme heat at all levels of government. Our understanding of how extreme heat and wildfire smoke compound is still nascent, which limits national and local capacity to plan ahead. Researchers and policymakers should invest in understanding how extreme heat and wildfire smoke compound and use this knowledge to design synergistic solutions that enhance infrastructure resilience and ultimately save lives. 

Intersecting Health Impacts of Extremely Hot, Smoky Days

Wildfire smoke and extreme heat can each be deadly. As mentioned, exposure to extreme heat causes the premature deaths of an estimated 10,000 people in the U.S. a year. Long-term exposure to extreme heat can also worsen chronic conditions like kidney disease, diabetes, hypertension, and asthma. Exposure to the primary component of wildfire smoke, known as fine particulate matter (PM2.5), contributes to an additional estimated 16,000 American deaths annually. Wildfire smoke exacerbates and causes various respiratory and cardiovascular effects along with other health issues, such as asthma attacks and heart failure, increasing risk of early death. 

New research suggests that the compounding health impacts of heat and smoke co-exposure could be even worse. For example, a recent analysis found that the co-occurrence of extreme heat and wildfire smoke in California leads to more hospitalizations for cardiopulmonary problems than on heat days or smoke days alone. 

Extreme heat also contributes to the formation of ground-level ozone. Like wildfire smoke, ground-level ozone can cause respiratory problems and exacerbate pre-existing conditions. This has already happened at scale: during the 2020 wildfire season, more than 68% of the western U.S. – about 43 million people – were affected in a single day by both ground-level ozone extremes and fine particulate matter from wildfire smoke.

Impacts on Populations Most Vulnerable to Combined Heat and Smoke

While extreme heat and wildfire smoke can pose health risks to everyone, there are some groups that are more vulnerable either because they are more likely to be exposed, they are more likely to suffer more severe health consequences when they are exposed, or both. Below, we highlight groups that are most vulnerable to extreme heat and smoke and therefore may be vulnerable to the compound impacts of these hazards. More research is needed to understand how the compound impacts will affect the health of these populations.

Housing-Vulnerable and Housing-Insecure People

Access to air conditioning at home and work, tree canopy cover, buildings with efficient wildfire smoke filtration and heat insulation and cooling capacities, and access to  smoke centers are all important protective factors against the effects of extreme heat and/or wildfire smoke. People lacking these types of infrastructure are at higher risk for the health effects of these two hazards as a result of increased exposure. In California, for example, communities with lower incomes and higher population density experience a greater likelihood of negative health impacts from hazards like wildfire smoke and extreme heat. 

Outdoor Workers

Representing about 33% of the national workforce, outdoor workers — farmworkers, firefighters, and construction workers — experience much higher rates of exposure to environmental hazards, including wildfire smoke and extreme heat, than other workers. Farmworkers are particularly vulnerable even among outdoor workers; in fact, they face a 35 times greater risk of heat exposure death than other outdoor workers. Additionally, outdoor workers are often lower-income, making it harder to afford protections and seek necessary medical care. Twenty percent of agricultural worker families live below the national poverty line.

Wildfire smoke exposure is estimated to have caused $125 billion in lost wages annually from 2007 to 2019 and extreme heat exposure is estimated to cause $100 billion in wage losses each year. Without any changes to policies and practice, these numbers are only expected to rise. These income losses may exacerbate inequities in poverty rates and economic mobility, which determine overall health outcomes.

Pregnant Mothers and Infants

Extreme heat and wildfire smoke also pose a significant threat to the health of pregnant mothers and their babies. For instance, preterm birth is more likely during periods of higher temperatures and during wildfire smoke events. This correlation is significantly stronger among people who were simultaneously exposed to extreme heat and wildfire smoke PM2.5.

Preterm birth comes with an array of risks for both the pregnant mothers and baby and is the leading cause of infant mortality. Babies born prematurely are more likely to have a range of serious health complications in addition to long-term developmental challenges. For the parent, having a preterm baby can have significant mental health impacts and financial challenges.

Children

Wildfire smoke and extreme heat both have significant impacts on children’s health, development, and learning. Children are uniquely vulnerable to heat because their bodies do not regulate temperatures as efficiently as adults, making it harder to cool down and putting their bodies under stress. Children are also more vulnerable to air pollution from wildfire smoke as they inhale more air relative to their weight than adults and because their bodies and brains are still developing.  PM2.5 exposure from wildfires has been attributed to neuropsychological effects, such as ADHD, autism, impaired school performance, and decreased memory. 

When schools remain open during extreme weather events like heat and smoke, student learning is impacted. Research has found that each 1℉ increase in temperature leads to 1% decrease in annual academic achievement. However, when schools close due to wildfire smoke or heat events, children lose crucial learning time and families must secure alternative childcare.

Low-income students are more likely to be in schools without adequate air conditioning because their districts have fewer funds available for school improvement projects. This barrier has only been partially remedied in recent years through federal investments.

Older Adults

Older adults are more likely to have multiple chronic conditions, many of which increase vulnerability to extreme heat, wildfire smoke, and their combined effects. Older adults are also more likely to take regular medication, such as beta blockers for heart conditions, which increase predisposition to heat-related illness.

The most medically vulnerable older adults are in long-term care facilities. There is currently a national standard for operating temperatures for long-term care facilities, requiring them to operate at or below 81℉. There is no correlatory standard for wildfire smoke. Preliminary studies have found that long-term care facilities are unprepared for smoke events; in some facilities the indoor air quality is no better than the outdoor air quality.

Challenges and Opportunities for the Healthcare Sector

The impacts of extreme heat and smoke have profound implications for public health and therefore for healthcare systems and costs. Extreme heat alone is expected to lead to $1 billion in U.S. healthcare costs every summer, while wildfire smoke is estimated to cost the healthcare system $16 billion every year from respiratory hospital visits and PM2.5 related deaths. 

Despite these high stakes, healthcare providers and systems are not adequately prepared to address wildfire smoke, extreme heat, and their combined effects. Healthcare preparedness and response is limited by a lack of real-time information about morbidity and mortality expected from individual extreme heat and smoke events. For example, wildfire smoke events are often reported on a one-month delay, making it difficult to anticipate smoke impacts in real time. Further, despite the risks posed by heat and smoke independently and when combined, healthcare providers are largely not receiving education about environmental health and climate change. As a result, physicians also do not routinely screen their patients for health risk and existing protective measures, such as the existence of air conditioning and air filtration in the home. 

Potential solutions to improve preparedness in the healthcare sector include developing more reliable real-time information about the potential impacts of smoke, heat, and both combined; training physicians in screening patients for risk of heat and smoke exposure; and training physicians in how to help patients manage extreme weather risks. 

Challenges and Opportunities for Federal, State, and Local Governments 

State and local governments have a role to play in building facilities that are resilient to extreme heat and wildfire smoke as well as educating people about how to protect themselves. However, funding for extreme heat and wildfire smoke is scarce and difficult for local jurisdictions in need to obtain. While some federal funding is available specifically to support smoke preparedness (e.g., EPA’s Wildfire Smoke Preparedness in Community Buildings Grant Program) and heat preparedness (e.g. NOAA NIHHIS’ Centers of Excellence), experts note that the funding landscape for both hazards is “limited and fragmented.” To date, communities have not been able to secure federal disaster funding for smoke or heat events through the Public Health Emergency Declaration or the Stafford Act. FEMA currently excludes the impacts on human health from economic valuations of losses from a disaster. As a result, many of these impacted communities never see investments from post-disaster hazard mitigation, which could potentially build community resilience to future events. Even if a declaration was made, it would likely be for one “event”, e.g. wildfire smoke or extreme heat, with recovery dollars targeted towards mitigating the impacts of that event. Without careful consideration, rebuilding and resilience investments might be maladaptive for addressing the combined impacts.

Next Steps

The Wildland Fire Mitigation and Management Commission report offers a number of recommendations to improve how the federal government can better support communities in preparing for the impacts of wildfire smoke and acknowledges the need for more research on how heat and wildfire smoke compound. FAS has also developed a whole-government strategy towards extreme heat response, resilience, and preparedness that includes nearly 200 recommendations and notes the need for more data inputs on compounding hazards like wildfire smoke. Policymakers at the federal level should support research at the intersection of these topics and explore opportunities for providing technical assistance and funding that builds resilience to both hazards.

Understanding and planning for the compound impacts of extreme heat and wildfire smoke will improve public health preparedness, mitigate public exposure to extreme heat and wildfire smoke, and minimize economic losses. As the overarching research at this intersection is still emerging, there is a need for more data to inform policy actions that effectively allocate resources and reduce harm to the most vulnerable populations. The federal government must prioritize protection from both extreme heat and wildfire smoke, along with their combined effects, to fulfill its obligation to keep the public safe.

2025 Heat Policy Agenda

It’s official: 2024 was the hottest year on record. But Americans don’t need official statements to tell them what they already know: our country is heating up, and we’re deeply unprepared.

Extreme heat has become a national economic crisis: lowering productivity, shrinking business revenue, destroying crops, and pushing power grids to the brink. The impacts of extreme heat cost our Nation an estimated $162 billion in 2024 – equivalent to nearly 1% of the U.S. GDP.

Extreme heat is also taking a human toll. Heat kills more Americans every year than hurricanes, floods, and tornadoes combined. The number of heat-related illnesses is even higher. And even when heat doesn’t kill, it severely compromises quality of life. This past summer saw days when more than 100 million Americans were under a heat advisory. That means that there were days when it was too hot for a third of our country to safely work or play.

We have to do better. And we can.

Attached is a comprehensive 2025 Heat Policy Agenda for the Trump Administration and 119th Congress to better prepare for, manage, and respond to extreme heat. The Agenda represents insights from hundreds of experts and community leaders. If implemented, it will build readiness for the 2025 heat season – while laying the foundation for a more heat-resilient nation.

Core recommendations in the Agenda include the following:

  1. Establish a clear, sustained federal governance structure for extreme heat. This will involve elevating, empowering, and dedicating funds to the National Interagency Heat Health Information System (NIHHIS), establishing a National Heat Executive Council, and designating a National Heat Coordinator in the White House.
  2. Amend the Stafford Act to explicitly define extreme heat as a “major disaster”, and expand the definition of damages to include non-infrastructure impacts.
  3. Direct the Secretary of Health and Human Services (HHS) to consider declaring a Public Health Emergency in the event of exceptional, life-threatening heat waves, and fully fund critical HHS emergency-response programs and resilient healthcare infrastructure.
  4. Direct the Federal Emergency Management Agency (FEMA) to include extreme heat as a core component of national preparedness capabilities and provide guidance on how extreme heat events or compounding hazards could qualify as major disasters.
  5. Finalize a strong rule to prevent heat injury and illness in the workplace, and establish Centers of Excellence to protect troops, transportation workers, farmworkers, and other essential personnel from extreme heat.
  6. Retain and expand home energy rebates, tax credits, LIHEAP, and the Weatherization Assistance Program, to enable deep retrofits that cut the costs of cooling for all Americans and prepare homes and other infrastructure against threats like power outages.
  7. Transform the built and landscaped environment through strategic investments in urban forestry and green infrastructure to cool communities, transportation systems to secure safe movement of people and goods, and power infrastructure to ready for greater load demand.

The way to prevent deaths and losses from extreme heat is to act before heat hits. Our 60+ organizations, representing labor, industry, health, housing, environmental, academic and community associations and organizations, urge President Trump and Congressional leaders to work quickly and decisively throughout the new Administration and 119th Congress to combat the growing heat threat. America is counting on you.

Executive Branch

Federal agencies can do a great deal to combat extreme heat under existing budgets and authorities. By quickly integrating the actions below into an Executive Order or similar directive, the President could meaningfully improve preparedness for the 2025 heat season while laying the foundation for a more heat-resilient nation in the long term. 

Streamline and improve extreme heat management.

More than thirty federal agencies and offices share responsibility for acting on extreme heat. A better structure is needed for the federal government to seamlessly manage and build resilience. To streamline and improve the federal extreme heat response, the President must:

Boost heat preparedness, response, and resilience in every corner of our nation.

Extreme heat has become a national concern, threatening every community in the United States. To boost heat preparedness, response, and resilience nationwide, the President must:

Usher in a new era of heat forecasting, research, and data.

Extreme heat’s impacts are not well-quantified, limiting a systematic national response. To usher in a new era of heat forecasting, research, and data, the President must:

Protect workers and businesses from heat.

Americans become ill and even die due to heat exposure in the workplace, a moral failure that also threatens business productivity. To protect workers and businesses, the President must:

Prepare healthcare systems for heat impacts.

Extreme heat is both a public health emergency and a chronic stress to healthcare systems. Addressing the chronic disease epidemic will be impossible without treating the symptom of extreme heat. To prepare healthcare systems for heat impacts, the President must:

Ensure affordably cooled and heat-resilient housing, schools, and other facilities.

Cool homes, schools, and other facilities are crucial to preventing heat illness and death. To prepare the build environment for rising temperatures, the President must:

Promote Housing and Cooling Access

Prepare Schools and Other Facilities

Legislative Branch

Congress can support the President in combating extreme heat by increasing funds for heat-critical federal programs and by providing new and explicit authorities for federal agencies.

Treat extreme heat like the emergency it is.

Extreme heat has devastating human and societal impacts that are on par with other federally recognized disasters. To treat extreme heat like the emergency it is, Congress must:

Build community heat resilience by readying critical infrastructure.

Investments in resilience pay dividends, with every federal dollar spent on resilience returning $6 in societal benefits. Our nation will benefit from building thriving communities that are prepared for extreme heat threats, adapted to rising temperatures, and capable of withstanding extreme heat disruptions. To build community heat resilience, Congress must:

Leveraging the Farm Bill to build national heat resilience.

Farm, food, forestry, and rural policy are all impacted by extreme heat. To ensure the next Farm Bill is ready for rising temperatures, Congress should:

Funding critical programs and agencies to build a heat-ready nation.

To protect Americans and mitigate the $160+ billion annual impacts of extreme heat, Congress will need to invest in national heat preparedness, response, and resilience. The tables on the following pages highlight heat-critical programs that should be extended, as well as agencies that need more funding to carry out heat-critical work, such as key actions identified in the Executive section of this Heat Policy Agenda.

An Agenda for Ensuring Child Safety in the AI Era

The next administration should continue to make responsible policy on Artificial intelligence (AI) and children, especially in K-12, a top priority and create an AI and Kids Initiative led by the administration. AI is transforming how children learn and live, and policymakers, industry, and educators owe it to the next generation to set in place a responsible policy that embraces this new technology while at the same time ensuring all children’s well-being, privacy, and safety is respected. The federal government should develop clear prohibitions, enforce them, and serve as a national clearinghouse for AI K-12 educational policy. It should also support comprehensive digital literacy related to AI.

Specifically, we think these policy elements need to be front of mind for decision-makers: build a coordinated framework for AI Safety; champion legislation to support youth privacy and online safety in AI; and ensure every child can benefit from the promise of AI. 

In terms of building a coordinated framework for AI Safety, the next administration should: ensure parity with existing child data protections; develop safety guidance for developers, including specific prohibitions to limit harmful designs, and inappropriate uses; and direct the National Institute of Standards and Technology (NIST) to serve as the lead organizer for federal efforts on AI safety for children. When championing legislation to support youth privacy and online safety in AI, the next administration should support the passage of online safety laws that address harmful design features that can lead to medically recognized mental health disorders and patterns of use indicating addiction-like behavior, and modernize federal children’s privacy laws including updating The Family Educational Rights and Privacy Act (FERPA) and passing youth privacy laws to explicitly address AI data use issues, including prohibiting developing commercial models from students’ educational information, with strong enforcement mechanisms. And, in order to ensure every child can benefit from the promise of AI, the next administration should  support comprehensive digital literacy efforts and prevent deepening the digital divide.

Importantly, policy and frameworks need to have teeth and need to take the burden off of individual states, school districts, or actors to assess AI tools for children. Enforcement should be tailored to specific laws, but should include as appropriate private rights of action, well-funded federal enforcers, and state and local enforcement. Companies should feel incentivized to act. The framework cannot be voluntary, enabling companies to pick and choose whether or not to follow recommendations.. We’ve seen what happens when we do not put in place guardrails for tech, such as increased risk of child addiction, depression and self-harm–and it should not happen again. We cannot say that this is merely a nascent technology and that we can delay the development of protections. We already know AI will critically impact our lives. We’ve watched tech critically impact lives and AI-enabled tech is both faster and potentially more extreme. 

Challenge and Opportunity

AI is already embedded in children’s lives and education. According to Common Sense Media research, seven in ten teens have used generative AI, and the most common use is for help with homework. The research also found most parents are in the dark about their child’s generative AI use–only a third of parents whose children reported using generative AI were aware of such use. Beyond generative AI, machine learning systems are embedded in just about every application kids use at school and at home. Further,  most teens and parents say schools have either no AI policy or have not communicated one. 

Educational uses of AI are recognized to pose higher risk, according to the EU Artificial Intelligence Act and other  international frameworks. The EU  recognized that risk management requires special consideration when an AI system is likely to be accessed by children. The U.S. has developed a risk management framework, but the U.S. has not yet articulated risk levels or developed a specific educational or youth profile using NIST’s Risk Management Framework. There is still a deep need to ensure that AI systems likely to be accessed by children, including in schools, to be assessed in terms of risk management and impact on youth.

It is well established that children and teenagers are vulnerable to manipulation by technology. Youth report struggling to set boundaries from technology, and according to a U.S. Surgeon General report, almost a third of teens say they are on social media almost constantly. Almost half of youth say social media has reduced their attention span, and takes time away from other activities they care about. They are unequipped to assess sophisticated and targeted advertising, as most children cannot distinguish ads from content until they are at least eight years old, and most children do not realize ads can be customized. Additionally,  social media design features lead, in addition to addiction, to teens suffering other mental or physical harm: from unattainable beauty filters to friend comparison to recommendation systems that promote harmful content, such as the algorithmic promotion of viral “challenges” that can lead to death.  AI technology is particularly concerning given its novelness, and the speed and autonomy at which the technology can operate, and the frequent opacity even to developers of AI systems about how inputs and outputs may be used or exposed. 

Particularly problematic uses of AI in products used in education and/or by children so far include products that use emotion detection, biometric data, facial recognition (built from scraping online images that include children), companion AI, automated education decisions, and social scoring.  This list will continue to grow as AI is further adopted.

There are numerous useful frameworks and toolkits from expert organizations like EdSafe, and TeachAI, and from government organizations like NIST, the National Telecommunications and Information Administration (NTIA), and Department of Education (ED). However, we need the next administration to (1) encourage Congress to pass clear rules regarding AI products used with children, (2) have NIST develop risk management frameworks specifically addressing use of AI in education and by children more broadly, and serve as a clearinghouse function so individual actors and states do not bear that responsibility, and (3) ensure frameworks are required and prohibitions are enforced. This is also reflected in the lack of updated federal privacy and safety laws that protect children and teens. 

Plan of Action

The federal government should take note of the innovative policy ideas bubbling up at the state level. For example, there is legislation and proposals in Colorado, California, Texas, and detailed guidance in over 20 states, including Ohio, Alabama, and Oregon. 

Policymakers should take a multi-pronged approach to address AI for children and learning, recognizing they are higher risk and therefore additional layers of protection should apply:

Recommendation 1. Build a coordinated framework an AI Safety and Kids Initiative at NIST

As the federal government further details risk associated with uses of AI, common uses of AI by kids should be designated or managed as high risk.  This is a foundational step to support the creation of guardrails or ensure protections for children as they use AI systems. The administration should clearly categorize education and use by children with in a risk level framework. For example, the EU is also considering risk in AI with the EU AI Act, which has different risk levels. If the risk framework includes education and AI systems that are likely to be accessed by children it provides a strong signal to policymakers at the state and federal level that these are uses that require protections (audits, transparency, or enforcement) to prevent or address potential harm. 

NIST, in partnership with others, should develop risk management profiles for platform developers building AI products for use in Education and for products likely to be accessed by children. Emphasis should be on safety and efficacy before technology  products come to market, with audits throughout development. NIST should:

Work in partnership with NTIA, FTC, CPSC, and HHS to  refine risk levels and risk management profiles for AI systems likely to be accessed by children.

The administration should task NIST’s Safety Institute to provide clarity on how safety should be considered for the use of AI in education and for AI systems likely to be accessed by children. This is accomplished through:

Recommendation 2. Ensure every child benefits from the promise of AI innovations 

The administration should support comprehensive digital literacy and prevent a deepening of the digital divide. 

Recommendation 3. Encourage Congress to pass clear enforceable rules re privacy and safety for AI products used by children

Champion Congressional updates to privacy laws like COPPA and FERPA to address use (especially for training) and sharing of personal information (PI) by AI tools. These laws can work in tandem, see for example recent proposed COPPA updates that would address use of technology in educational settings by children. 

Push for Congress to pass AI specific legislation addressing the development and deployment of AI systems for use by children

Support Congressional passage of online safety laws that address harmful design features in technology–specifically addressing design features that can lead to medically recognized mental health disorders like anxiety, depression, eating disorders, substance use, and suicide, and patterns of use indicating addiction-like behavior, as in Title I of the Senate-passed Kids Online Safety and Privacy Act.

Moving Forward

One ultimate recommendation is that, critically, standards and requirements need teeth. Frameworks should require that companies comply with legal requirements or face effective enforcement (such as by a well-funded expert regulator, or private lawsuits), with tools such as fines and injunctions. We have seen with past technological developments that voluntary frameworks and suggestions will not adequately protect children. Social media for example has failed to voluntarily protect children and poses risks to their mental health and well being. From exacerbating body image issues to amplifying peer pressure and social comparison, from encouraging compulsive device use to reducing attention spans, from connecting youth to extremism, illegal products, and deadly challenges, the financial incentives do not appear to exist for technology companies to appropriately safeguard children on their own. The next Administration can support enforcement by funding government positions who will be enforcing such laws.

A Peer Support Service Integrated Into the 988 Lifeline

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:

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:

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.

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.

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.

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.

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.

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.

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.

Antitrust in the AI Era: Strengthening Enforcement Against Emerging Anticompetitive Behavior

The advent of artificial intelligence (AI) has revolutionized business practices, enabling companies to process vast amounts of data and automate complex tasks in ways previously unimaginable. However, while AI has gained much praise for its capabilities, it has also raised various antitrust concerns. Among the most pressing is the potential for AI to be used in an anticompetitive manner. This includes algorithms that facilitate price-fixing, predatory pricing, and discriminatory pricing (harming the consumer market), as well as those which enable the manipulation of wages and worker mobility (harming the labor market). More troubling perhaps is the fact that the overwhelming majority of the AI landscape is controlled by just a few market players. These tech giants—some of the world’s most powerful corporations—have established a near-monopoly over the development and deployment of AI. Their dominance over necessary infrastructure and resources makes it increasingly challenging for smaller firms to compete.

While the antitrust enforcement agencies—the FTC and DOJ—have recently begun to investigate these issues, they are likely only scratching the surface. The covert and complex nature of AI makes it difficult to detect when it is being used in an anticompetitive manner. To ensure that business practices remain competitive in the era of AI, the enforcement agencies must be adequately equipped with the appropriate strategies and resources. The best way to achieve this is to (1) require the disclosure of AI technologies during the merger-review process and (2) reinforce the enforcement agencies’ technical strategy in assessing and mitigating anticompetitive AI practices.

Challenge & Opportunity

Since the late 1970s, antitrust enforcement has been in decline, in part due to a more relaxed antitrust approach put forth by the Chicago school of economics. Both the budgets and the number of full-time employees at the enforcement agencies have steadily decreased, while the volume of permitted mergers and acquisitions has risen (see Figure 1). This resource gap has limited the ability of the agencies to effectively oversee and regulate anticompetitive practices.

Figure 1. Merger Enforcement vs. Total Filings

Source: Department of Justice Antitrust Division Operations

Changing attitudes surrounding big business, as well as recent shifts in leadership at the enforcement agencies—most notably President Biden’s appointment of Lina Khan to FTC Chair—have signaled a more aggressive approach to antitrust law. But even with this renewed focus, the agencies are still not operating at their full potential. 

This landscape provides a significant opportunity to make some much-needed changes. Two areas for improvement stand out. First, agencies can make use of the merger review process to aid in the detection of anticompetitive AI practices. In particular, the agencies should be on the look-out for algorithms that facilitate price-fixing, where competitors use AI to monitor and adjust prices automatically, covertly allowing for tacit collusion; predatory pricing algorithms, which enable firms to undercut competitors only to later raise prices once dominance is achieved; and dynamic pricing algorithms, which allow firms to discriminate against different consumer groups, resulting in price disparities that may distort market competition. On the labor side, agencies should screen for wage-fixing algorithms and other data-driven hiring practices that may suppress wages and limit job mobility. Requiring companies to disclose the use of such AI technologies during merger assessments would allow regulators to examine and identify problematic practices early on. This is especially useful for flagging companies with a history of anticompetitive behavior or those involved in large transactions, where the use of AI could have the strongest anticompetitive effects.

Second, agencies can use AI to combat AI. Research has demonstrated that AI can be more effective in detecting anticompetitive behavior than other traditional methods. Leveraging such technology could transform enforcement capabilities by allowing agencies to cover more ground despite limited resources. While increasing funding for these agencies would be requisite, AI nonetheless provides a cost-effective solution, enhancing efficiency in detecting anticompetitive practices, without requiring massive budget increases.

The success of these recommendations hinges on the enforcement agencies employing technologists who have a deep understanding of AI. Their knowledge on algorithm functionality, the latest insights in AI, and the interplay between big data and anticompetitive behavior is instrumental. A detailed discussion of the need for AI expertise is covered in the following section.

Plan Of Action

Recommendation 1. Require Disclosure of AI Technologies During Merger-Review.

Currently, there is no formal requirement in the merger review process that mandates the reporting of AI technologies. This lack of transparency allows companies to withhold critical information that may help agencies determine potential anticompetitive effects. To effectively safeguard competition, it is essential that the FTC and DOJ have full visibility of businesses’ technologies, particularly those that may impact market dynamics. While the agencies can request information on certain technologies further in the review process, typically during the second request phase, a formalized reporting requirement would provide a more proactive approach. Such an approach would be beneficial for several reasons. First, it would enable the agencies to identify anticompetitive technologies they might have otherwise overlooked. Second, an early assessment would allow the agencies to detect and mitigate risk upfront, rather than having to address it post-merger or further along in the merger review process, when remedies may be more difficult to enforce. This is particularly applicable with regard to deep integrations that often occur between digital products post-merger. For instance, the merger of Instagram and Facebook complicated the FTC’s subsequent efforts to challenge Meta. As Dmitry Borodaenko, a former Facebook engineer, explained: 

“Instagram is no longer viable outside of Facebook’s infrastructure. Over the course of six years, they integrated deeply… Undoing this would not be a simple task—it would take years, not just the click of a button.”

Lastly, given the rapidly evolving nature of AI, this requirement would help the agencies identify trends and better determine which technologies are harmful to competition, under what circumstances, and in which industries. Insights gained from one sector could inform investigations in other sectors, where similar technologies are being deployed. For example, the DOJ recently filed suit against RealPage, a property management software company, for allegedly using price-fixing algorithms to coordinate rent increases among competing landlords. The case is the first of its kind, as there had not been any previous lawsuit addressing price-fixing in the rental market. With this insight, however, if the agencies detect similar algorithms during the merger review process, they would be better equipped to intervene and prevent such practices.

There are several ways the government could implement this recommendation. To start, The FTC and DOJ should issue interpretive guidelines specifying that anticompetitive effects stemming from AI technologies are within the purview of the Hart-Scott-Rodino (HSR) Act, and that accordingly, such technologies should be disclosed in the pre-merger notification process. In particular, the agencies should instruct companies to report detailed descriptions of all AI technologies in use, how they might change post-merger, and their potential impact on competition metrics (e.g., price, market share). This would serve as a key step in signaling to companies that AI considerations are integral during merger review. Building on this, Congress could pass legislation mandating AI disclosures, thereby formalizing the requirement. Ultimately, in a future round of HSR revisions, the agencies could incorporate this mandate as a binding rule within the pre-merger framework. To avoid unnecessary burden on businesses, reporting should only be required when AI plays a significant role in the company’s operations or is expected to post-merger. What constitutes a ‘significant role’ should be left to the discretion of the agencies but could include AI systems central to core functions such as pricing, customer targeting, wage-setting, or automation of critical processes.

Recommendation 2. Reinforce the FTC and DOJ’s Technical Strategy in Assessing and Mitigating Anticompetitive AI Practices.

Strengthening the agencies’ ability to address AI requires two actions: integrating computational antitrust strategies and increasing technical expertise. A wave of recent research has highlighted AI as a powerful tool in helping detect anticompetitive behavior. For instance, scholars at the Stanford Computational Antitrust Project have demonstrated that methods such as machine learning, natural language processing, and network analysis can assist with tasks, ranging from uncovering collusion between firms to distinguishing digital markets. While the DOJ has already partnered with the Project, the FTC could benefit by pursuing a similar collaboration. More broadly, the agencies should deepen their technical expertise by expanding workshops and training with AI academic leaders. Doing so would not only provide them with access to the most sophisticated techniques in the field, but would also help bridge the gap between academic research and real-world implementation. Examples may include the use of machine learning algorithms to identify price-fixing and wage-setting; sentiment analysis, topic modeling, and other natural language processing tools to detect intention to collude in firm communications; or reverse-engineering algorithms to predict outcomes of AI-driven market manipulation. 

Leveraging such computational strategies would enable regulators to analyze complex market data more effectively, enhancing the efficiency and precision of antitrust investigations. Given AI’s immense power, only a small—but highly skilled—team is needed to make significant progress. For instance, the UK’s Competition and Markets Authority (CMA) recently stood up a Data, Technology and Analytics unit, whereby they implement machine learning strategies to investigate various antitrust matters. For the U.S. agencies to facilitate this, the DOJ and FTC should hire more ML/AI experts, data scientists, and technologists, who could serve several key functions. First, they could conduct research on the most effective methods for detecting collusion and anticompetitive behavior in both digital and non-digital markets. Second, based on such research, they could guide the implementation of selected AI solutions in investigations and policy development. Third, they could perform assessments of AI technologies, evaluating the potential risks and benefits of AI applications in specific markets and companies. These assessments would be particularly useful during merger review, as previously discussed in Recommendation 1. Finally, they could help establish guidelines for transparency and accountability, ensuring the responsible and ethical use of AI both within the agencies and across the markets they regulate.

To formalize this recommendation, the President should submit a budget proposal to Congress requesting increased funding for the FTC and DOJ to (1) hire technology/AI experts and (2) provide necessary training for other selected employees on AI algorithms and datasets. The FTC may separately consider using its 6(b) subpoena powers to conduct a comprehensive study of the AI industry or of the use of AI practices more generally (e.g., to set prices or wages). Finally, the agencies should strive to foster collaboration between each other (e.g., establishing a Joint DOJ-FTC Computational Task Force), as well as with those in academia and the private sector, ​​to ensure that enforcement strategies remain at the cutting edge of AI advancements.

Conclusion

The nation is in the midst of an AI revolution, and with it comes new avenues for anticompetitive behavior. As it stands, the antitrust enforcement agencies lack the necessary tools to adequately address this growing threat.

However, this environment also presents a pivotal opportunity for modernization. By requiring the disclosure of AI technologies during the merger review process, and by reinforcing the technical strategy at the FTC and DOJ, the antitrust agencies can strengthen their ability to detect and prevent anticompetitive practices. Leveraging the expertise of technologists in enforcement efforts can enhance the agencies’ capacity to monitor levels of competition in markets, as well as allow them to identify patterns between certain technologies and violations of antitrust.

Given the rapid pace of AI advancement, a proactive effort triumphs over a reactive one. Detecting antitrust violations early allows agencies to save both time and resources. To protect consumers, workers, and the economy more broadly, it is imperative that the FTC and DOJ adapt their enforcement strategies to meet the complexities of the AI era.

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.

Clearing the Path for New Uses for Generic Drugs

The labeling-only 505(b)(2) NDA pathway for non-manufacturers to seek FDA approval

Repurposing generic drugs as new treatments for life-threatening diseases is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. The low profit margins for generic drugs mean that pharmaceutical companies rarely invest in research, regulatory efforts, and marketing for new uses. Nonprofit organizations and other non-commercial non-manufacturers are increasing efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. However, these non-manufacturers find it difficult to obtain regulatory approval in the U.S. They face significant challenges in using the existing approval pathways, specifically in: 1) providing the FDA with required chemistry, manufacturing, and controls (CMC) data, 2) providing the FDA with product samples, and 3) conducting post-marketing surveillance. Without a straightforward path for approval and updating drug labeling, non-manufacturers have relied on off-label use of repurposed drugs to drive uptake. This practice results in outdated labeling for generics and hinders widespread clinical adoption, limiting patient access to these potentially life-saving treatments. 

To encourage greater adoption of generic drugs in clinical practice – that is, to encourage the repurposing of these drugs – the FDA should implement a dedicated regulatory pathway for non-manufacturers to seek approval of new indications for repurposed generic drugs. A potential solution is an extension of the existing 505(b)(2) new drug application (NDA) approval pathway. This extension, the “labeling-only” 505(b)(2) NDA, would be a dedicated pathway for non-manufacturers to seek FDA approval of new indications for well-established small molecule drugs when multiple generic products are already available. The labeling-only 505(b)(2) pathway would be applicable for repurposing drugs for any disease. Creating a regulatory pathway for non-manufacturers would unlock access to innovative therapies and enable the public to benefit from the enormous potential of low-cost generic drugs.

Challenge and Opportunity

The opportunity for generic drug repurposing

On-patent, branded drugs are often unaffordable for Americans. Due to the high cost of care, 42% of patients in the U.S. exhaust their life savings within two years of a cancer diagnosis. Generic drug repurposing – the process of finding new uses for FDA-approved generic drugs – is a major opportunity to quickly create low-cost and accessible treatment options for many diseases. In oncology, hundreds of generic drugs approved for non-cancer uses have been tested as cancer treatments in published preclinical and clinical studies. 

The untapped potential for generic drug repurposing in cancer and other diseases is not being realized because of the lack of market incentives. Pharmaceutical companies are primarily focused on de novo drug development to create new molecular and chemical entities. Typically, pharmaceutical companies will invest in repurposing only when the drugs are protected by patents or statutory market exclusivities, or when modification to the drugs can create new patent protection or exclusivities (e.g., through new formulations, dosage forms, or routes of administration). Once patents and exclusivities expire, the introduction of generic drugs creates competition in the marketplace. Generics can be up to 80-85% less expensive than their branded counterparts, driving down overall drug prices. The steep decline in prices means that pharmaceutical companies have little motivation to invest in research and marketing for new uses of off-patent drugs, and this loss of interest often starts in the years preceding generic entry.

In theory, pharmaceutical companies could repurpose generics without changing the drugs and apply for method-of-use patents, which should provide exclusivity for new indications and the potential for higher pricing. However, due to substitution of generic drugs at the pharmacy level, method-of-use patents are of little to no practical value when there are already therapeutically equivalent products on the market. Pharmacists can dispense a generic version instead of the patent-protected drug product, even if the substituted generic does not have the specific indication in its labeling. Currently, nearly all U.S. states permit substitution by the pharmacy, and over a third have regulations that require generic substitution when available.

Nonprofits like Reboot Rx and other non-commercial non-manufacturers are therefore stepping in to advance the use of repurposed generic drugs across many diseases. Non-manufacturers, which do not manufacture or distribute drugs, aim to ensure there is substantial evidence for new indications of generic drugs and then advocate for their clinical use. Regulatory approval would accelerate adoption. However, even with substantial evidence to support regulatory review, non-manufacturers find it difficult or impossible to seek approval for new indications of generic drugs. There is no straightforward pathway to do so within the current U.S. regulatory framework without offering a specific, manufactured version of the drug. This challenge is not unique to the U.S.; recent efforts in the European Union (EU) have sought to address the regulatory gap. In the 2023 EU reform of pharmaceutical legislation, Article 48 is currently under review by the European Parliament as a potential solution to allow nonprofit entities to spearhead submissions for the approval of new indications for authorized medicinal products with the European Medicines Agency. To maximize the patient impact of generic drugs in America, non-manufacturers should be able to drive updates to FDA drug labeling, enabling widespread clinical adoption of repurposed drugs in a formal, predictable, and systematic manner.

The importance of FDA approval

Drugs that are FDA-approved can be prescribed for any indication not listed on the product labeling, often referred to as “off-label use”. Since non-manufacturers face significant challenges pursuing regulatory approval for new indications, they often must rely on advocating for off-label use of repurposed drugs.

While off-label use is widely accepted and helpful for specific circumstances, there are significant advantages to having FDA approval of new drug indications included in labeling. FDA drug labeling is intended to contain up-to-date information about drug products and ensures that the necessary conditions of use (including dosing, warnings, and precautions) are communicated for the specific indications. It is the primary authoritative source for making informed treatment decisions and is heavily valued by the medical community. Approval may increase the likelihood of uptake by clinical guidelines, pathways systems, and healthcare payers. Indications with FDA approval may generate greater awareness of the treatment options, leading to a broader and more rapid impact on clinical practice. 

Clinical practice guidelines are often the leading authority for prescribers and patients regarding off-label use. In oncology, for example, the National Comprehensive Cancer Network (NCCN) Guidelines are commonly used guidelines that include many off-label uses. However, guidelines do not exist for every disease and medical specialty, which can make it more difficult to gain acceptance for off-label uses. The Centers for Medicare and Medicaid Services (CMS) policy routinely covers off-label drug uses if they are listed in certain compendia. The NCCN Compendia, which is based on the NCCN Guidelines, is the only accepted compendium that is disease-specific.

Off-label use requires more effort from individual prescribers and patients to independently evaluate new drug data, thereby slowing uptake of the treatments. This can be especially difficult for community-based physicians, who need to remain up-to-date on new treatment options across many diseases. Off-label prescribing can also introduce medico-legal risks, such as malpractice. These burdens and risks limit off-label prescribing, even when there is supportive evidence for the new uses.

As new uses for generic drugs are discovered, it is crucial to update the labeling to ensure alignment with current clinical practice. Outdated generic drug labeling means that prescribers and patients may not have access to all the necessary information to understand the full risk-benefit profile. Americans deserve to have access to all effective treatment options – especially low-cost and widely available generic drugs that could help mitigate the financial toxicity and health inequities faced by many patients. For the public benefit, the FDA should support approaches that remove regulatory barriers for non-manufacturers and modernize drug labeling.

Existing pathways for manufacturers to obtain FDA approval 

The current FDA approval system is based on the idea that sponsors have discrete physical drug products. Traditionally, sponsors seeking FDA approval are pharmaceutical companies or drug manufacturers that intend to produce (or contract for production), distribute, and sell the finished drug product. For the purposes of FDA regulation, “drug” refers to a substance intended for use in the treatment or prevention of disease; “drug product” is the final dosage form that contains a drug substance and inactive ingredients made and sold by a specific manufacturer. One drug can be present on the market in multiple drug products. In the current regulatory framework, drug products are approved through one of the following:

Manufacturers can add new indications to their approved labeling without modifying the drug product through existing pathways. With supportive clinical evidence for the new indication, the NDA holder can file a supplemental NDA (sNDA), while an ANDA holder may submit a 505(b)(2) NDA as a supplement to their existing ANDA. As previously discussed, the drug product will likely be subject to pharmacy-level substitution with any available therapeutically equivalent generic. The marketing exclusivities that sponsors may receive from the FDA do not protect against this substitution. Therefore, these pathways are rarely, if ever, used by pharmaceutical companies when there are already multiple generic manufacturers of the product. 

Challenges for non-manufacturers in using existing pathways

Since manufacturers are not incentivized to seek regulatory approval for new indications, labeling changes are more likely to happen if driven by non-manufacturers. Yet non-manufacturers face significant challenges in utilizing the existing regulatory pathways. Sponsors must submit the following information for all NDAs for the FDA’s review: 1) clinical and nonclinical data on the safety and effectiveness of the drug for the proposed indication; 2) the proposed labeling; and 3) chemistry, manufacturing, and controls (CMC) data describing the methods of manufacturing and the controls to maintain the drug product’s quality. 

To submit and maintain NDAs, non-manufacturer sponsors would need to address the following challenges: 

  1. Providing the FDA with required CMC data. NDA sponsors must provide CMC data for FDA review. Non-manufacturers would not produce physical drug products, and therefore they would not have information on the manufacturing process. 
  2. Providing the FDA with product samples. If requested, NDA sponsors must have the drug products and other samples (e.g., drug substances or reference standards) available to support the FDA review process and must make available for inspection the facilities where the drug substances and drug products are manufactured. Non-manufacturers would not have physical drug products to provide as samples, the capabilities to produce them, or access to the facilities where they are made. 
  3. Conducting post-marketing surveillance. Post-marketing responsibilities to maintain an NDA include conducting annual safety reporting and maintaining a toll-free number for the public to call with questions or concerns. Non-manufacturers, such as small nonprofits, may not have the bandwidth or resources to meet these requirements.

Within the current statutory framework, a non-manufacturer could sponsor a 505(b)(2) NDA to obtain approval of a new indication by partnering with a current manufacturer of the drug – either an NDA or ANDA holder. The manufacturer would help meet the technical requirements of the 505(b)(2) application that the non-manufacturer could not fulfill independently. Through this partnership, the non-manufacturer would acquire the CMC data and physical drug product samples from the manufacturer and rely on the manufacturer’s facilities to fulfill FDA inspection and quality requirements.

Once approved, the 505(b)(2) NDA would create a new drug product with indication-specific labeling, even though the product would be identical to an existing product under a previous NDA or ANDA. The 505(b)(2) NDA would then be tied to the specific manufacturer due to the use of their CMC data, and that manufacturer would be responsible for producing and distributing the drug product for the new indication.

As a practical matter, this pathway is rarely attainable. Manufacturers of marketed drug products, particularly generic drug manufacturers, lack the incentives needed to partner with non-manufacturers. Manufacturers may not want to provide their CMC data or samples because it may prompt FDA inspection of their facilities, require an update to their CMC information, or open the door to product liability risks. The existing incentive structure strongly discourages generic drug manufacturers from expending any additional resources on researching new uses or making any changes to their product labeling that would deviate from the original RLD product. 

Plan of Action 

To modernize drug labeling and enhance clinical adoption of generic drugs, the FDA should implement a dedicated regulatory pathway for non-manufacturers to seek approval of new indications for repurposed generic drugs. Ultimately, such a pathway would enable drug repurposing and be a crucial step toward equitable healthcare access for Americans. We propose a potential solution – a “labeling-only” 505(b)(2) NDA – as an extension of the existing 505(b)(2) approval pathway. 

Overview of the proposed labeling-only 505(b)(2) NDA pathway 

The labeling-only 505(b)(2) NDA would enable non-manufacturers to reference CMC information from previous FDA determinations and, when necessary, provide the FDA with samples of commercially available drug products. Through this approach, the new indication would not be tied to a specific drug product made by one manufacturer. There is no inherent necessity for a new indication of a generic drug to be exclusively linked to a single manufacturer or drug product when the FDA has already approved multiple therapeutically equivalent generic drugs. Any of these interchangeable drug products would be considered equally safe and effective for the new indication, and patients could receive any of these drug products due to pharmacy-level substitution. 

We describe non-manufacturer repurposing sponsors as entities that intend to submit or reference clinical data through a labeling-only 505(b)(2) NDA. This pathway is designed to expand the FDA-approved labeling of generic drugs for new indications, including those that may already be considered the standard of care. Non-manufacturers do not have the means to independently produce or distribute drug products. Instead, they intend to show that there is substantial evidence to support the new use through FDA approval, and then advocate for the indication in clinical practice. This evidence may be based on their research or research performed by other entities, including clinical trials and real-world data analyses.

The labeling-only 505(b)(2) NDA pathway helps address the three major challenges non-manufacturers face in pursuing regulatory approval. Through this pathway, non-manufacturers would be able to: 

  1. Reference the FDA’s previous determinations on CMC data. Currently, a 505(b)(2) NDA can reference the FDA’s previous determinations of safety and effectiveness for an approved drug product. For eligible generic drugs, the labeling-only 505(b)(2) NDA would build on this practice by allowing non-manufacturer sponsors to reference the FDA’s previous determinations on any NDA or ANDA that the manufacturing process and CMC data are adequate to meet regulatory standards.
  2. Provide the FDA with product samples using commercially available drug product samples. Currently, it is up to the discretion of the FDA whether or not to request samples in the review of an application. With the labeling-only 505(b)(2) NDA, non-manufacturers would provide the FDA with samples of commercially available products from generic manufacturers. Given that the FDA would have already evaluated the products and their bioequivalence to the RLD during the previous reviews, it is not expected that the FDA would need to re-examine the product at the level of requesting samples, except potentially to examine the packaging and physical presentation of the product for compatibility with the new indication and conditions of use. The facilities where the drugs are made would remain available for inspection, under the same terms and conditions as the existing, approved marketing applications. 
  3. Manage post-marketing responsibilities. Since most post-marketing surveillance and adverse event reporting are drug product-specific, these obligations would continue to be the responsibility of the manufacturer of the physical drug product dispensed. With the labeling-only 505(b)(2) NDA, the non-manufacturer would not have product-specific obligations because they are not putting a new product into the marketplace. However, we anticipate the non-manufacturer would be responsible for the repurposed indication on their labeling, including but not limited to post-marketing surveillance as well as indication-specific adverse event reporting and reasonable follow-up.

Under the labeling-only 505(b)(2) NDA, the non-manufacturer sponsor would not introduce a new physical drug product into the market. The new labeling created by the approval would not expressly be associated with one specific product. The non-manufacturer’s labeling would refer to the drug by its established generic name. In that way, the non-manufacturer sponsor’s approval and labeling could be applicable to all equivalent versions of the drug product and would be available for patients to receive from their pharmacy in the same way that generic drugs are typically dispensed at the pharmacy. That is, with the benefit of pharmacy-level substitution, patients could receive any available, therapeutically equivalent drug products from any current manufacturer. 

Eligibility criteria

We envision the users of this pathway to be non-manufacturers that conduct drug repurposing research for the public benefit, including organizations like nonprofits and patient advocacy groups. The FDA should implement and enforce additional guardrails on eligibility to ensure that sponsors operate in good faith and cannot otherwise meet traditional NDA requirements. This process may include pre-submission meetings and reviews. The labeling-only 505(b)(2) NDA should be held to the FDA’s standard level of rigor and scrutiny of safety and effectiveness for the proposed indication during the review process.

The labeling-only 505(b)(2) would only be suitable for well-established, commercially available small molecule generic drugs, which can be identified as: 

  1. Drugs with a U.S. Pharmacopeia and National Formulary (USP-NF) monograph. The USP-NF monograph system ensures the uniformity of available products on the market by setting a consensus minimum standard of identity, strength, quality, and purity among all marketed versions of a drug. It is expressly recognized in the Federal Food, Drug, and Cosmetics Act (FDCA). The USP-NF strives to have substance and product monographs for all FDA-approved drugs. USP-NF monographs for generics are commonly available because the drugs have been on the market for a long time and are typically produced by multiple manufacturers. Drug products in the U.S. market must conform to the standards in the USP-NF, when available, to avoid possible charges of adulteration and misbranding. 

By statute and regulation, the FDA already allows for NDAs and ANDAs to reference the USP-NF to satisfy some CMC requirements, such as for specifications of the drug substance. As an illustration of the acceptance of the USP-NF, clinical trial protocols requiring the use of background therapy or supportive care, as well as trials testing medical devices requiring the use of a drug product, often will specify that any available version of the drug product meeting USP-NF standards can be used. We propose that products without USP-NF monographs, including certain newer drugs and drugs with especially complicated manufacturing processes that are not conducive to standardization, would not be eligible for the labeling-only 505(b)(2) pathway.

  1. Drugs with multiple A-rated, therapeutically equivalent products in the FDA Orange Book. The FDA does not regulate which specific products are dispensed or substituted for a given drug prescription. The listing of therapeutic equivalents in the Orange Book facilitates the seamless replacement of drug products from different manufacturers in clinical practice. Therapeutically equivalent drug products: i) have demonstrated bioequivalence to the RLD; ii) have the same strength, dosage form, and route of administration as the RLD; and iii) are labeled for the same conditions of use as the RLD. Therapeutic equivalents that meet these criteria are designated “A-rated” in the Orange Book. A-rated drug products are substitutable for any other version of that A-rated drug product, including the RLD itself. 

Implementation 

The labeling-only 505(b)(2) NDA pathway could be implemented through an FDA guidance document interpreting the current statute and regulations or through legislation that clarifies the FDA’s existing authority. Guidance documents contain the FDA’s interpretation of a given policy on regulatory issues. The FDA’s Center for Drug Evaluation and Research (CDER) could issue new guidance that allows for interpretation of the existing statute, thereby officially authorizing previous FDA determinations of acceptable CMC data to be referenceable for eligible generic drugs and adjusting drug sample requirements. Alternatively, the labeling-only 505(b)(2) could be enacted by Congress through a statutory change by incorporation into FDCA, which is up for reauthorization through the Prescription Drug User Fee Act (PDUFA) in 2027, or other congressional acts as appropriate. FDA guidance would be a faster pathway to adoption, while statutory authorization would offer additional safeguards for the continuance of the pathway long term.

The labeling-only 505(b)(2) NDA pathway could be funded through user fees, which are established by PDUFA for the cost to file and maintain NDAs. However, many nonprofit sponsors would not be able to afford the same user fees as for-profit pharmaceutical manufacturers. Relevant statutes will likely need to be updated to create a different fee schema for non-manufacturers who use the labeling-only 505(b)(2) pathway. In a similar spirit to reducing barriers to maintaining up-to-date labeling, the 2017 PDUFA update waived the fee for submitting an sNDA, which is how an existing RLD holder would update their labeling with new indication information.

Conclusion

Patients need new and affordable treatment options for diseases that have a devastating societal impact, and repurposing generic drugs can help address this need. Nonprofits and other non-manufacturers are driving these efforts forward due to a lack of interest from pharmaceutical companies. As momentum gains for generic drug repurposing, the U.S. regulatory system needs a pathway for non-manufacturers to seek FDA approval of new indications for existing generic drugs. Our proposed labeling-only 505(b)(2) NDA would eliminate undue administrative burden, enabling non-manufacturers to pursue FDA approval of new indications. It would allow the FDA to provide the public with the most up-to-date drug labeling, improving the ability of patients and physicians to make informed treatment decisions. This dedicated pathway would increase the availability of effective treatment options while reducing costs for the American healthcare system.

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
Could the FDA make labeling changes for repurposed generic drugs without the process being driven by non-manufacturer sponsors?

The FDA does not have sufficient bandwidth or resources to meet the opportunity we have with repurposed generic drugs. To be the primary driver of labeling changes for repurposed generic drugs, the FDA would need to identify repurposing opportunities and also thoroughly compile and evaluate the safety and effectiveness data for the new indications. Project Renewal in FDA’s Oncology Center of Excellence is working with RLD holders to update the labeling of certain older oncology drugs where the outdated labeling does not reflect their current clinical use. The initial focus of Project Renewal is limited, and newly repurposed treatments are not included within its scope. For newly repurposed treatments, the FDA could evaluate the drugs and post to the Federal Register reports on their safety and effectiveness that could be referenced by manufacturers. However, this approach is burdensome as it would require a significant commitment of FDA resources. By introducing a motivated, third-party non-manufacturer as the primary driver for labeling changes, non-manufacturers can contribute expertise and resources to enable faster data evaluation for more drugs.

If a repurposed indication for a generic drug was approved through the labeling-only 505(b)(2) NDA pathway, would current manufacturers be required to update their labeling?

The pre-existing NDA sponsor could update their labeling to add the new indication through an sNDA that references the labeling-only 505(b)(2) NDA. ANDA holders would then be legally required to match their labeling to that of the RLD. The FDA should determine whether all current manufacturers would be required to update their labeling following approval of the new indication, and if so, the appropriate process.

Could drug repurposing and expanding the market for generics cause an increase in drug prices?

Generic drugs play a vital role in the U.S. healthcare system by decreasing drug spending and increasing the accessibility of essential medicines. Generics account for 91% of prescriptions filled in the U.S. Expanding the market with generics for new indications could lead to short-term price increases above the inflation rate for off-patent branded and generic drugs in some unlikely circumstances. For example, if a new use for a generic drug substantially increases demand for the drug, there is a short-term risk that prices for the drug or potential substitutes could rise until manufacturers build more capacity to increase supply. To mitigate this risk, generic manufacturers could be notified about potential increases in demand so they can plan for increased production.

Would off-label uses of drugs still be covered by healthcare payers if there is a pathway to seek approval for those uses?

Generally, healthcare payers are not required to cover or reimburse for off-label uses of drugs. Unless a drug undergoes utilization management, payers cover most generic drugs for off-label uses because coverage is agnostic of indication. Clinical practice guidelines are highly influential in the widespread adoption of off-label treatments into the standard of care and are often referenced by payers making reimbursement decisions. In oncology, many off-label treatments are included in guidelines; only 62% of treatments in the NCCN are aligned with FDA-approved indications. For example, more than half of the NCCN recommendations for metastatic breast cancer are off-label treatments. Due to the breadth of off-label use, we anticipate payers would continue to cover repurposed generic drugs used off-label, even if there is a pathway available for non-manufacturers to pursue FDA approval.

Would a labeling-only 505(b)(2) NDA sponsor receive any marketing exclusivities for the new indications?

We do not envision any form of exclusivity being granted for indications pursued via a labeling-only 505(b)(2) NDA. Given that the non-manufacturer sponsor would rely on existing products produced by multiple generic manufacturers, there is no new product to grant exclusivity. Even if some form of exclusivity were given to the non-manufacturer, it would be insufficient to guarantee the use of any particular drug product over another due to pharmacy-level substitution.

Using Pull Finance for Market-driven Infrastructure and Asset Resilience

The incoming administration should establish a $500 million pull-financing facility to ensure infrastructure and asset resiliency with partner nations by catalyzing the private sector to develop cutting-edge technologies. The increasing frequency of extreme weather events, which caused over $200 billion in global economic losses in 2023, is disrupting global supply chains and exacerbating migration pressures, particularly for the U.S. Investing in climate resilience abroad offers a significant opportunity for U.S. businesses in technology, engineering, and infrastructure, while also supporting job creation at home. 

Pull-finance mechanisms can maximize the efficiency and impact of U.S. investments, fostering innovation and driving sustainable solutions to address global vulnerabilities. Unlike traditional funding which second-guesses the markets by supporting only selected innovators, pull financing drives results by relying on the market to efficiently allocate resources to achievement, fostering competition and rewarding the most impactful solutions. Managed and steered by the U.S. government, the pull-financing facility would fund infrastructure and asset resiliency results delivered by the world’s cutting-edge innovators, mitigating the effects of extreme weather events and ultimately supporting U.S. interests abroad. 

Challenge and Opportunity 

The increasing frequency and severity of extreme weather events pose significant risks to global economic stability, with direct implications for U.S. interests. In 2023 alone, natural disasters caused over $200 billion in global economic losses with much of the damage concentrated in regions critical to global supply chains. U.S. businesses that depend on these supply chains face rising costs and disruptions, which translate into higher costs for U.S. businesses and consumers, undermining economic competitiveness.

Beyond the economic dimension, these vulnerabilities exacerbate socio-political pressures. Climate-induced displacement is accelerating, with 32.6 million people internally displaced by disasters in 2022. Most displaced individuals that cross borders migrate to countries neighboring their own, which are ill-equipped to handle the influx, often further destabilizing fragile states. For the U.S., this translates into increased migration pressures at its southern border, where natural disasters are already a driving force behind migration from Central America. Addressing these root causes through proactive resiliency investments abroad would reduce long-term strain on the U.S. and bolster stability in strategically important regions.

In addition to economic and social risks, resilience is now a key front in global competition. The People’s Republic of China has rapidly expanded its influence in developing nations through initiatives like the Belt and Road, financing over $200 billion in energy and infrastructure projects since 2013. A significant portion of these projects focus on resiliency investments, enabling China to position itself as a partner of choice for nations with asset and infrastructure exposure. This growing influence comes at the expense of U.S. global leadership.

In the context of these challenges, it is especially concerning that much of the U.S.’s existing spending may not be achieving the results it could. A recent audit of USAID climate initiatives highlights concerns around limited transparency and effectiveness in its development funding. The inefficient use of this funding is leaving opportunities on the table for U.S. businesses and workers. Global investments in adaptation and resiliency are projected to reach $500 billion annually by 2050. Resilience projects abroad could open substantial markets for American engineering, technology, and infrastructure firms. For instance, U.S.-based companies specializing in resilient agriculture, flood defense systems, advanced irrigation technologies, and energy infrastructure stand to benefit from increased demand. Domestically, the manufacturing and export of these solutions could generate significant economic activity, supporting high-quality jobs and revitalizing industrial sectors.

Pull finance presents an opportunity to increase the cost effectiveness of resiliency funding—and ensure this funding achieves U.S. interests. Pull finance mechanisms like results-based financing and Advance Market Commitments (AMC) reward successful solutions that meet specific criteria, promoting private sector engagement and market-driven problem-solving. Unlike traditional “push” financing, which funds chosen teams or projects directly, pull financing sets a goal and allows any innovator who reaches it to claim the reward, fostering      competitive problem-solving without pre-selected winners. This approach includes various mechanisms – such as prize challenges, milestone payments, advance market commitments, and subscription models – each suited to different issues and industries.

Pull financing is particularly effective for addressing complex challenges with unclear or emerging solutions, or in areas with limited commercial incentives. It has proven successful in various contexts, such as the first Trump Administration’s rapid development of COVID-19 vaccines through Operation Warp Speed and GAVI’s introduction of the pneumococcal vaccine in low-income countries. These initiatives highlight how pull financing can stimulate breakthrough innovations that efficiently address immediate needs in collaboration with private actors through effective incentives.  

Pull finance can be used to efficiently advance infrastructure and asset resilience goals while also providing opportunities for U.S. innovators and industry. By stimulating demand for critically needed technologies for development like resilient seeds and energy storage solutions, as detailed in Box 1, well-designed pull finance would help link U.S. technology innovators to addressing needs of U.S. partners. As such, pull finance can play a critical role in positioning the U.S. as a partner of first choice for countries seeking to access U.S. innovation to meet resilience needs.

What would the design of a pull financing mechanism look like in practice?  

Resilient Seeds

Agriculture in Africa is highly susceptible to extreme weather events, with limited adoption of effective farming technologies. Developing new seed varieties capable of withstanding these events and optimizing resource use has the potential to yield significant societal benefits.

While push financing can support the development of resource-efficient and productive seeds, it often lacks the ability to ensure they meet essential quality standards, like flavor and appearance, and are user-friendly across farming, transport and marketing stages. In contrast, pull financing can effectively incentivize private sector innovation across all critical dimensions, including end-user take-up. 

A pull mechanism for resilient seeds, using a milestone payment mechanism, could cover a portion of R&D costs initially, with additional payments tied to successful lab trials. Depending on the obstacles to scaling – whether they arise from the innovator/distributor side or the farmer side – a small per-user payment to the innovator or per-user subsidy could help sustain market demand.

The design and scale of a pull financing mechanism to promote the rollout of new seeds and crop varieties will largely depend on the market readiness of the various seed types involved. Establishing effective pull mechanisms for seed development is estimated to cost between $50 million and $100 million, aiming for significant outreach to farmers. Along with supporting improved livelihoods for farmers, this small investment would open opportunities for U.S. technology innovators and companies. 

Pull Finance Initiative for Infrastructure and Asset Resiliency in the Caribbean

The Caribbean is one of the regions most vulnerable to extreme weather events, making it critical to engage the private sector in developing and adopting technologies suited to Small Island Developing States (SIDS). Challenges such as limited demand and high costs hinder innovation and investment in these small markets, leaving key areas like agriculture and access underserved. Overcoming these market failures requires innovative approaches to create sustainable incentives for private sector involvement.

Pull finances offers a promising solution to drive resiliency in SIDS. By tying payments to measurable outcomes, this approach will incentivize the development and deployment of technologies that might otherwise remain inaccessible. 

For example, pull finance could be used to stimulate the creation of energy storage solutions designed to withstand extreme weather conditions in remote areas. This could be help address the critical needs of SIDS’ such as Guyana which face energy security challenges linked to extreme weather conditions, especially in remote and dispersed areas. Energy storage technologies exist, but companies are not motivated to invest in tailored innovation for local needs because end-users cannot pay prices that compensate for innovation efforts. Pull finance could address this by committing to purchase an amount large enough that nudges companies to develop a tailored product, without raising market prices. Success would require partnerships with local SMEs, caps in installation costs, and specifications on storage capacity, along with relevant technology partners such as those in the U.S.. This approach would support immediate adaptation needs and lay the foundation for sustainable, market-driven solutions that ensure long-term resilience for SIDS.

Plan of Action 

The new administration should establish a dedicated pull-financing facility to accelerate the scale-up and deployment of development solutions with partner nations. In line with other major U.S. climate initiatives, this facility could be managed by USAID’s Bureau for Resilience, Environment and Food Security (REFS), with significant support from USAID’s Innovation, Technology, and Research (ITR) Hub, in partnership with the U.S. Department of State. By leveraging USAID’s deep expertise in development and SPEC’s strategic diplomacy, this collaboration would ensure the facility addresses LMIC-specific needs while aligning with broader U.S. objectives.

The recent audit of USAID climate initiatives referenced above highlights concerns on the limited transparency and effectiveness in its climate funding. Thus, we recommend that USAID assesses the impact of its climate spending under the 2020-2024 administration and reallocates a portion of funds from less effective or stalled initiatives to this new facility. We recognize that it may be challenging to quickly identify $500 million in underperforming projects to close and reassign. Therefore, in addition to reallocating existing resources, we strongly recommend appealing to new funding for this initiative. This approach will ensure the new facility has the financial backing it needs to drive meaningful outcomes. Additional resources could also be sourced from large multilateral organizations such as the World Bank.

To enhance the facility’s impact, we recommend the active participation of agencies such as the National Oceanic and Atmospheric Administration (NOOA), particularly through the Climate and Societal Interactions Division (CSI)   in the Steering Committee,

We propose that this facility draw on the example of the UK’s planned Climate Innovation Pull Facility (CIPF), a £185 million fund which aims to fund development-relevant pull finance projects in LMICs such as those proposed by the Center for Global Development and Instiglio. This can be achieved through the following steps:

Recommendation 1. Establish the pull-finance facility, governance and administration with an initial tranche of $500 million. 

The initiative proposes establishing a pull-finance facility with an initial fund of $500 million. This facility will be overseen by a steering board chaired by USAID and comprising senior representatives from USAID, the State Department, NOOA , which will set the strategic direction and make final project selections. 

A facility management team, led by USAID, will be responsible for ensuring the successful implementation of the facility, including the selection and delivery of 8 to 16 projects. The final number of projects will depend on the launch readiness of prioritized technologies and their potential impact, with the selection process guided by criteria that align with the facility’s strategic goals. The facility management team will also be responsible for contracting with project and evaluation partners, compliance with regulations, risk management, monitoring and evaluation, as well as payouts. Additionally, the facility management team will provide incubation support for selected initiatives, including technical consultations, financial modeling, contracting expertise, and feasibility assessments.

Designing pull financing mechanisms is complex and requires input from specialized experts, including scientists, economists, and legal advisors, to identify suitable market gaps and targets. An independent Technical Advisory Group (TAG) led by USAID and comprised of such experts should be established to provide technical guidance and quality assurance. The TAG will identify priority resilience topics, such as reducing crop-residue burning or developing resilient crops. It will also focus on sectors where the U.S. can enhance its global competitiveness, which faces high upfront costs and risks. Additionally, the TAG will be responsible for technical review and recommendations of the shortlisted project proposals to inform final selection, as well as provide general advice and challenge to the facility management team and steering board.

We suggest starting with $500 million as the minimum required to be credible and relevant as well as responsive to the scale of global need. Further, experience shows that pull mechanisms need to be of sufficient scale to sustainably shift markets. For instance, GAVI’s pneumococcal vaccine AMC entailed a $1.5 billion commitment and Frontier’s carbon capture AMC likewise entails over $1 billion in commitments.  

Recommendation 2. Set up a performance management system to measure, assess and ensure impact.

The U.S. pull financing facility will implement a robust monitoring, evaluation, and learning (MEL) framework to track and enhance its impact and drive ongoing improvement through feedback and learning. 

The facility manager will develop a logical framework (logframe) that includes key performance indicators (KPIs) and a progress and risk dashboard to track monthly performance. These tools will enable effective monitoring of progress, assessment of impact, and proactive risk management, allowing for quick responses to unexpected challenges or underperformance.

Monthly check-ins with an independent evaluation partner, along with oversight from a dedicated MEL committee, will ensure consistent and rigorous evaluation as well as continuous learning. Additionally, knowledge management and dissemination activities will facilitate the sharing of insights and best practices across the program.

Recommendation 3. Establish a knowledge management hub to facilitate the sharing of results and insights and ensure coordination across pull-financing projects. 

The hub will work closely with community partners and stakeholders – such as industry and tech leaders and manufacturers – in areas like resiliency-focused finance and innovation to build strong support and develop resources on essential topics, including the effectiveness of pull financing and optimal design strategies. Additionally, the hub will promote collaboration across projects focused on similar technological and production advancements, generating synergies that enhance their collective impact and benefits.

Once the proof of concept is established through clear evidence and learning, the facility will likely secure further stakeholder buy-in and attract additional funding for a scale up phase covering a larger portfolio of projects. 

Conclusion 

The federal government should establish a $500 million pull-financing facility to accelerate technologies for resilience in the face of growing development challenges. This initiative will unlock high-return investments and increase cost effectiveness of resiliency spending, driving economic and geopolitical goals. Managed and steered by USAID and the State Department, with support from NOOA, the facility would foster breakthroughs in critical areas like resilient infrastructure, energy, and technology, benefiting both U.S. businesses and our international partners. By investing strategically, the U.S. can ensure both national and global stability.

The authors thank FAS for the reviews and feedback, along with Ranil Dissanayake, Florence Oberholtzer, and Laura Mejia Villada for their valuable contribution to this piece.

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 are some of the main constraints to pull financing and how can they be overcome?

Pull financing mechanisms, such as prize competitions, milestone payments, and Advanced Market Commitments (AMCs) often face regulatory and legal challenges due to their dependency on successful outcomes for funding disbursement (CGD, 2021; CGD, 2023). First, it can make cashflow management challenging as federal law requires that legally binding financial commitments be made if the necessary appropriated funds are available, resulting in upfront scoring of costs, even if the actual expenditures occur years later. The uncertainty surrounding innovation and payouts can also create risk aversion, as most funding accounts are not “no-year” accounts, meaning committed funds can expire if competition goals are unmet within the designated timeframe.


To mitigate these constraints, agencies can use budgetary workarounds like no-year appropriations, allowing them to reallocate de-obligated funds from canceled competitions to new initiatives. Other options include employing credit-type scoring to discount costs based on the likelihood of non-payment and making non-legally binding commitments backed by third parties, such as international institutions, to avoid these challenges altogether.

What is the expected timeline for the establishment and cost breakdown for this fund?

The entire fund is expected to span a maximum of five () years. The initial 12 months will concentrate on identifying eight (8) to 16 projects through comprehensive due diligence and providing incubation support. In the subsequent four (4) years, the focus will shift to project delivery.

How is this initiative different from existing U.S. initiatives such as USAID’s Climate Finance for Development Accelerator (CFDA)?

In contrast to the traditional push-funding approach of the CFDA program, our proposed pull-finance initiative introduces a unique market-shaping component aimed at driving key infrastructure and resilience solutions to fruition. In contrast to CFDA, pull finance addresses demand-side risks by providing demand-side guarantees of a future market for the technology or solution. It also mitigates R&D risk by combining incentives for research and development, ensuring that a viable market exists once the technology is developed. This approach helps accelerate market creation and innovation in high-risk, high-innovation sectors where demand or technological maturity is uncertain.

A National Guidance Platform for AI Acquisition

Streamlining the procurement process for more equitable, safe, and innovative government use of AI

The federal government’s approach to procuring AI systems serves two critical purposes: it not only shapes industry and academic standards but also determines how effectively AI can enhance public services. By leveraging its substantial purchasing power responsibly, the government can encourage high-quality, inclusive AI solutions that address diverse citizen needs while setting a strong precedent for innovation and accountability. Guidance issued in October 2024 by the White House’s Office of Management and Budget (OMB) gives recommendations on how agencies should use AI systems, focusing on public trust and data transparency. However, it is unclear how these guidelines align with general procurement regulations like the Federal Acquisition Regulation (FAR).

To reduce bureaucratic hurdles and encourage safe government innovation, the General Services Administration (GSA) should develop a digital platform that guides federal agencies through an “acquisition journey” for AI procurement. This recommendation is for streamlining guidance for procuring AI systems and should not be confused with the use of AI to simplify the procurement process.  The platform should be intuitive and easy to navigate by clearly outlining the necessary information, requirements, and resources at each process stage, helping users understand what they need at any point in the procurement lifecycle. Such a platform would help agencies safely procure and implement AI technologies while staying informed on the latest guidelines and adhering to existing federal procurement rules. GSA should take inspiration from Brazil’s well-regarded Public Procurement Platform for Innovation (CPIN). CPIN helps public servants navigate the procurement process by offering best practices, risk assessments, and contract guidance, ensuring transparency and fairness at each stage of the procurement process.

Challenges and Opportunities

The federal government’s approach to AI systems is a crucial societal benchmark, shaping standards that ripple through industries, academia, and public discourse. Along with shaping the market, the government also faces a delicate balancing act when it comes to its own use of AI: it must harness AI’s potential to dramatically enhance efficiency and effectiveness in public service delivery while simultaneously adhering to the highest AI safety and equity standards. As such, the government’s handling of AI technologies carries immense responsibility and opportunity. 

The U.S. federal government procures AI for numerous different tasks—from analyzing weather hazards and expediting benefits claims to processing veteran feedback. Positive impacts could potentially include faster and more accurate public services, cost savings, better resource allocation, improved decision-making based on data insights, and enhanced safety and security for citizens. However, risks can include privacy breaches, algorithmic bias leading to unfair treatment of certain groups, over-reliance on AI for critical decisions, lack of transparency in AI-driven processes, and cybersecurity vulnerabilities. These issues could erode public trust, inhibit the adoption of beneficial AI, and exacerbate existing social inequalities.

The federal government has recently published several guidelines on the acquisition and use of AI systems within the federal government, specifically how to identify and mitigate systems that may impact public trust in these systems. For example:

This guidance, coupled with the already extensive set of general procurement regulations such as the Federal Acquisition Regulation (FAR ), can be overwhelming for public servants. In conversations with the author of this memo, stakeholders, including agency personnel and vendors, frequently noted that they needed clarification about when impact and risk assessments should occur in the FAR process.

How can government agencies adequately follow their mandate to provide safe and trustworthy AI for public services while reducing the bureaucratic burden that can result in an aversion to government innovation? A compelling example comes from Brazil. The Public Procurement Platform for Innovation (CPIN), managed by the Brazilian Ministry of Development, Industry, Commerce, and Services (MDIC), is an open resource designed to share knowledge and best practices on public procurement for innovation. In 2023, the platform was recognized by the Federal Court of Auditors (TCU—the agency that oversees federal procurement) as an essential new asset in facilitating public service. The CPIN helps public servants navigate the procurement process by diagnosing needs and selecting suitable contracting methods through questionnaires. Then, it orients agencies through a procurement journey, identifying what procurement process should be used, what kinds of dialogue the agency should have with potential vendors and other stakeholders, guidance for risk assessments, and contract language. The platform is meant to guide public servants through each stage of the procurement process, ensuring they know their obligations for transparency, fairness, and risk mitigation at any given time. CPIN is open to the public and is meant to be a resource, not new requirements that supplant existing mandates by Brazilian authorities. 

Here in the U.S., the Office of Federal Procurement (OFFP) within the Office of Management and Budget (OMB) in partnership with the General Services Administration (GSA) and the Council of Chief AI Officers (CAIO), should develop a similar centralized resource to help federal agencies procure AI technologies safely and effectively. This platform would ensure agencies have up-to-date guidelines on AI acquisition integrated with existing procurement frameworks.

This approach is beneficial because:

GSA has created similar tools before. For example, the Generative AI Acquisition Resource Guide assists federal buyers in procuring and implementing generative AI technologies by describing key considerations, best practices, and potential challenges associated with acquiring generative AI solutions. However, this digital platform would go one step further and align best practices, recommendations, and other AI considerations within the processes outlined in the FAR and other procurement methods. 

Plan of Action

Recommendation 1. Establish a Working Group led by the OMB OFPP, with participation from GSA, OSTP, and the CAIO Council, tasked with systematically mapping all processes and policies influencing public sector AI procurement.

This includes direct AI-related guidance and tangential policies such as IT, data management, and cybersecurity regulations. The primary objective is identifying and addressing existing AI procurement guidance gaps, ensuring that the forthcoming platform can provide clear, actionable information to federal agencies. To achieve this, the working group should:

Conduct a thorough review of current mandates (see the FAQ for a non-exhaustive list of current mandates), executive orders, OMB guidance, and federal guidelines that pertain to AI procurement. This includes mapping out the requirements and obligations agencies must meet during acquisition. Evaluate if these mandates come with explicit deadlines or milestones that need to be integrated into the procurement timeline (e.g., AI risk assessments, ethics reviews, security checks)

Conduct a gap analysis to identify areas where existing AI procurement guidance needs to be clarified, completed, or updated. Prioritize gaps that can be addressed by clarifying existing rules or providing additional resources like best practices rather than creating new mandates to avoid unnecessary regulatory burdens. For example, guidance on handling personally identifiable information within commercially available information, guidance on data ownership between government and vendors, and the level of detail required for risk assessments. 

Categorize federal guidance into two main buckets: general federal procurement guidance (e.g., Federal Acquisition Regulation [FAR]) and agency-specific guidelines (e.g., individual AI policies from agencies such as DoD’s AI Memos or NASA’s Other Transaction Authorities [OTAs]). Ensure that agency-specific rules are clearly distinguished on the platform, allowing agencies to understand when general AI acquisition rules apply and when specialized guidance takes precedence. Since the FAR may take years to update to reflect agency best practices, this could help give visibility to potential gaps. 

Recommendation 2. The OMB OFPP-GSA-CAIO Council Working Group should convene a series of structured engagements with government and external stakeholders to co-create non-binding, practical guidance addressing gaps in AI procurement to be included in the platform.

These stakeholders should include government agency departments (e.g., project leads, procurement officers, IT departments) and external partners (vendors, academics, civil society organizations). The working group’s recommendations should focus on providing agencies with the tools, content, and resources they need to navigate AI procurement efficiently. Key focus areas would include risk management, ethical considerations, and compliance with cybersecurity policies throughout the procurement process. The guidance should also highlight areas where more frequent updates will be required, particularly in response to rapid developments in AI technologies and federal policies.

Topics that these stakeholder convenings could cover include: 

Procurement Process

Transparency 

Resources:

Recommendation 3. The OPPF, in collaboration with GSA and the United States Digital Service (USDS) should then develop an intuitive, easy-to-navigate digital platform that guides federal agencies through an “acquisition journey” for AI procurement.

While the focus of this memo is on the broader procurement of AI systems, this digital platform could also benefit from the incorporation of AI, for example, by using a chatbot that is able to refer government users to the specific regulations governing their use cases. At each process stage, the platform should clearly outline the necessary information collected during the previous phases of this project to help users understand exactly what is needed at any given point in the procurement lifecycle.

The platform should serve as a central repository that unites all relevant AI procurement requirements, guidance from federal regulations (e.g., FAR, OMB memos), and insights from stakeholder convenings (e.g., vendors, academics, civil society). Each procurement stage should feature the most up-to-date guidance, ensuring a comprehensive and organized resource for federal employees.

The system should be designed for ease of navigation, potentially modeled after Brazil’s CPIN, which is organized like a city subway map. Users can begin with a simple questionnaire recommending a specific “subway line” or procurement process. Each “stop” along the line would represent a key stage in the procurement journey, offering relevant guidance, requirements, and best practices for that phase. 

OPPF and GSA must regularly update the platform to reflect the latest federal AI and procurement policies and evolving best practices from government, civil society, and industry sources. Regular updates ensure that agencies use the most current information, especially as AI technologies and policies evolve rapidly.

The Federal Acquisition Institute within OFPP should create robust training programs to familiarize public servants with the new platform and how to use it effectively. These programs should explain how the platform supports AI acquisition and links to broader agency AI strategies.

  1. Roll out the platform gradually through agency-specific capacity-building sessions, demonstrating its utility for different departments. These sessions should show how the resource can help public servants meet their AI procurement needs and align with their agency’s strategic AI goals.
  2. Develop specialized training modules for different government stakeholders. For example, project teams might focus on aligning AI systems with mission objectives, procurement specialists on contract compliance, and IT departments on technical evaluations and cybersecurity.
  3. To ensure broad understanding and transparency, host public briefings for external stakeholders such as vendors, civil society organizations, and researchers. These sessions would clarify AI procurement requirements, fostering trust and collaboration between the public and private sectors.

Conclusion

The proposed centralized platform would represent a significant step forward in streamlining and standardizing the acquisition of AI technologies across federal agencies. By consolidating guidance, resources, and best practices into a user-friendly digital interface, this initiative would address gaps in the current AI acquisition landscape without increasing bureaucracy. This initiative supports individual agencies in their AI adoption efforts. It promotes a cohesive, government-wide approach to responsible AI implementation, ultimately benefiting both public servants and the citizens they serve.

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 do federal agencies have to consider when procuring AI technologies?

There are so many considerations based on a particular agency’s many needs. A non-exhaustive list of legislation, executive orders, standards and other guidance relating to innovation procurement and agency use of AI can be found here. One approach to top-level simplification and communication is to create something similar to Brazil’s city subway map, discussed above.

Could this be a platform be used for other types of procurement, especially innovation procurement in general?

The original Brazilian CPIN is designed for general innovation procurement and is agnostic to specific technologies or services. However, this memo focuses on artificial intelligence (AI) in light of recent guidance from the Office of Management and Budget (OMB) and the growing interest in AI from both the Biden Administration and the incoming Trump Administration. Establishing a platform specifically for AI system procurement could serve as a pilot for developing a broader innovation procurement platform.

How does this platform ensure compliance with safety, equity, and ethical standards in AI procurement?

The platform seeks to ensure responsible public sector AI by mitigating information asymmetries between government agencies and vendors, specifically by:



  • Incorporating the latest OMB guidelines on AI system usage, focusing on human rights, safety, and data transparency. These guidelines are seamlessly integrated into each step of the procurement process.

  • Throughout the “acquisition journey,” the platform should include clarifying checkpoints where agencies can demonstrate how their procurement plans align with established safety, equity, and ethical standards.

  • Prompting agencies to consider how procured AI systems will address context-specific risks by integrating agency-specific guidance (e.g., the Department of Labor’s AI Principles) into the existing AI procurement frameworks.

Enhancing Local Capacity for Disaster Resilience

Across the United States, thousands of communities, particularly rural ones, don’t have the capacity to identify, apply for, and manage federal grants. And more than half of Americans don’t feel that the federal government adequately takes their interests into account. These factors make it difficult to build climate resilience in our most vulnerable populations. AmeriCorps can tackle this challenge by providing the human power needed to help communities overcome significant structural obstacles in accessing federal resources. Specifically, federal agencies that are part of the Thriving Communities Network can partner with the philanthropic sector to place AmeriCorps members in Community Disaster Resilience Zones (CDRZs) as part of a new Resilient Communities Corps. Through this initiative, AmeriCorps would provide technical assistance to vulnerable communities in accessing deeply needed resources. 

There is precedent for this type of effort. AmeriCorps programming, like AmeriCorps VISTA, has a long history of aiding communities and organizations by directly helping secure grant monies and by empowering communities and organizations to self-support in the future. The AmeriCorps Energy Communities is a public-private partnership that targets service investment to support low-capacity and highly vulnerable communities in capitalizing on emerging energy opportunities. And the Environmental Justice Climate Corps, a partnership between the Environmental Protection Agency (EPA) and AmeriCorps, will place AmeriCorps VISTA members in historically marginalized communities to work on environmental justice projects. 

A new initiative targeting service investment to build resilience in low-capacity communities, particularly rural communities, would help build capacity at the local level, train a new generation of service-oriented individuals in grant writing and resilience work, and ensure that federal funding gets to the communities that need it most.

Challenge and Opportunity  

A significant barrier to getting federal funding to those who need it the most is the capacity of those communities to search and apply for grants. Many such communities lack both sufficient staff bandwidth to apply and search for grants and the internal expertise to put forward a successful application. Indeed, the Midwest and Interior West have seen under 20% of their communities receive competitive federal grants since the year 2000. Low-capacity rural communities account for only 3% of grants from the Federal Emergency Management Agency (FEMA)’s flagship program for building community resilience. Even communities that receive grants often lack the capacity for strong grant management, which can mean losing monies that go unspent within the grant period.

This is problematic because low-capacity communities are particularly vulnerable to natural disasters from flooding to wildfires. Out of the nearly 8,000 most at-risk communities with limited capacity to advocate for resources, 46% are at risk for flooding, 36% are at risk for wildfires, and 19% are at risk for both.

Ensuring communities can access federal grants to help them become more climate resilient is crucial to achieving an equitable and efficient distribution of federal monies, and to building a stronger nation from the ground up. These objectives are especially salient given that there is still a lot of federal money available through the Inflation Reduction Act (IRA) and the Infrastructure Investment and Jobs Act (IIJA) that low-capacity communities can tap into for climate resilience work. As of April 2024, only $60 billion out of the $145 billion in the IRA for energy and climate programs had been spent. For the IIJA, only half of the nearly $650 billion in direct formula funding had been spent. 

The Biden-Harris Administration has tried to address the mismatch between federal resilience funding and community capacity in a variety of ways. The Administration has deployed resources for low-capacity communities, agencies tasked with allocating funds from the IRA and IIJA have held information sessions, and the IRA and IIJA contain over a hundred technical assistance programs. Yet there still is not enough support in the form of human capacity at the local level to access grants and other resources and assistance provided by federal agencies. AmeriCorps members can support communities in making informed decisions, applying for federal support, and managing federal financial assistance. Indeed, state programs like the Maine Climate Corps, include aiding communities with both resilience planning and emergency management assistance as part of their focus. Evening the playing field by expanding deployment of human capital will yield a more equitable distribution of federal monies to the communities that need it the most. 

AmeriCorps’ Energy Communities initiative serves as a model for a public-private partnership to support low-capacity communities in meeting their climate resilience goals. Over a three-year period, the program will invest over $7.8 million from federal agencies and philanthropic dollars to help communities designated by the Interagency Working Group on Coal & Power Plant Communities & Economic Revitalization on issues revolving around energy opportunity, environmental cleanup, and economic development to help communities capitalize on emerging energy opportunities. 

There is an opportunity to replicate this model towards resilience. Specifically, the next Administration can leverage the Federal Emergency Management Agency (FEMA’s) Community Disaster Resilience Zone (CDRZ) designations to target AmeriCorps support to the communities that need it most. Doing so will not only build community resilience, but will help restore trust in the federal government and its programs (see FAQ).

Plan of Action

The next administration can support vulnerable communities in building climate resilience by launching a new Resilient Communities Corps through AmeriCorps. The initiative can be launched through a three-part Plan of Action: (1) find a philanthropic partner to fund AmeriCorps placements in CDRZs, (2) engage federal agencies that are part of the Thriving Communities Network to provide resilience training and support to Corps members, and (3) use the CDRZ designations to help guide where AmeriCorps members should be placed.  

Recommendation 1. Secure philanthropic funding 

American service programs have a history of utilizing philanthropic monies to fund programming. The AmeriCorps Energy Communities is funded with philanthropic monies from Bloomberg Philanthropies. California Volunteers Fund (CVF), the Waverly Street Foundation, and individual philanthropists helped fund the state Climate Corps. CVF has also provided assistance and insights for state Climate Corps officials as they develop their programs. 

A new Resilient Communities Corps under the AmeriCorps umbrella could be funded through one or several major philanthropic donors, and/or through grassroots donations. Widespread public support for AmeriCorps’ ACC that transcends generational and party lines presents the opportunity for new grassroots donations to supplement federal monies allocated to the program along with tapping the existing network of foundations, individuals, companies, and organizations that have provided past donations. The Partnership for the Civilian Climate Corps (PCCC), which has had a history of collaborating with the ACC’s federal partners, would be well suited to help spearhead this grassroots effort. 

America’s Service Commissions (ASC), which represents state service commissions, can also help coordinate with state service commissions to find local philanthropic monies to fund AmeriCorps work in CDRZs. There is precedent for this type of fundraising. Maine’s state service commission was able to secure private monies for one Maine Service Fellow. The fellow has since worked with low-capacity communities in Maine on climate resilience. ASC can also work with state service commissions to identify current state, private, and federally funded service programming that could be tapped to work in CDRZs or are currently working in CDRZs. This will help tie in existing local service infrastructure.  

Recommendation 2. Engage federal agencies participating in the Thriving Communities Network and the American Climate Corps (ACC) interagency working group. 

Philanthropic funding will be helpful but not sufficient in launching the Resilient Communities Corps. The next administration should also engage federal agencies to provide AmeriCorps members participating in the initiative with training on climate resilience, orientations and points of contact for major federal resilience programs, and, where available, additional financial support for the program. The ACC’s interagency working group has centered AmeriCorps as a multiagency initiative that has directed resources and provides collaboration in implementing AmeriCorps programming. The Resilient Communities Corps will be able to tap into this cross-agency collaboration in ways that align with the resilience work already being done by partnership members. 

There are currently four ACC programs that are funded through cooperation with other federal agencies. These are the Working Lands Climate Corps with the U.S. Department of Agriculture (USDA)’s Natural Resources and Conservation Service, AmeriCorps NCCC Forest Corps with the USDA Forest Service, Energy Communities AmeriCorps with the Department of Interior and the Department of Commerce, and the Environmental Justice Corps, which was announced in September 2024 and will launch in 2025, with the EPA. The Resilient Communities Corps could be established as a formal partnership with one or more federal agencies as funding partners.

In addition, the Resilient Communities Corps can and should leverage existing work that federal agencies are doing to build community capacity and enhance community climate resilience. For instance, USDA’s Rural Partners Network helps rural communities access federal funding while the EPA’s Environmental Justice Thriving Communities Technical Assistance Centers Program provides training and assistance for communities to build the capacity to navigate, develop proposals, and manage federal grants. The Thriving Communities Network provides a forum for federal agencies to provide technical assistance to communities trying to access federal monies. Corps members, through the network, can help federal agencies provide communities they are working with building capacity to access this technical assistance. 

Recommendation 3. Use CDRZ designations and engage with state service commissions to guide Resilient Communities Corps placements

FEMA, through its National Risk Index, has identified communities across the country that are most vulnerable to the climate crisis and need targeted federal support for climate resilience projects. CDRZs provide an opportunity for AmeriCorps to identify low-capacity communities that need their assistance in accessing this federal support. With assistance from partner agencies and philanthropic dollars, the AmeriCorps can fund Corps members to work in these designated zones to help drive resources into them. As part of this effort, the ACC interagency working group should be broadened to include the Department of Homeland Security (which already sponsors FEMA Corps).

In 2024, the Biden-Harris Administration announced Federal-State partnerships between state service commissions and the ACC. This partnership with state service commissions will help AmeriCorps and partner agencies identify what is currently being done in CDRZs, what is needed from communities, and any existing service programming that could be built up with federal and philanthropic monies. State service commissions understand the communities they work with and what existing programming is currently in place. This knowledge and coordination will prove invaluable for the Resilient Communities Corps and AmeriCorps more broadly as they determine where to allocate members and what existing service programming could receive Resilient Communities Corps designation. This will be helpful in deciding where to focus initial/pilot Resilient Communities Corps placements.

Conclusion

A Resilient Communities Corps presents an incredible opportunity for the next administration to support low-capacity communities in accessing competitive grants in CDRZ-designated areas. It will improve the federal government’s impact and efficiency of dispersing grant monies by making grants more accessible and ensure that our most vulnerable communities are better prepared and more resilient in the face of the climate crisis, introduce a new generation of young people to grant writing and public service, and help restore trust in federal government programs from communities that often feel overlooked.

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 Resilient Communities initiative cost?

Funding for one AmeriCorps member in each of FEMA’s 483 designated Community Disaster Resilience Zones would cost around $14,500,000 per year. This is with an estimate of $30,000 per member. However, this figure will be subject to change due to overhead and living adjustment costs.

Why focus on CDRZ communities? Aren’t there lots of other communities that could also benefit from support?

There are many communities that could benefit from additional support when it comes to building resilience. Headwater Economics, a research institute in Montana, has flagged that the CDRZ does not account for all low-capacity communities hampered in their efforts to become more climate resilient. But the CDRZ designation does provide a federal framework that can serve as a jumping-off point for AmeriCorps to begin to fill capacity gaps. These designations, identified through the National Risk Index, provide a clear picture for where federal, public and private monies are needed the most. These communities are some of the most vulnerable to climate change, lack the resources for resilience work, and need the human capacity to access them. Because of these reasons, the CDRZ communities provide the ideal and most appropriate area for the Resilient Communities Corps to first serve in.

How would the Resilient Communities initiative help restore local trust in federal government?

Funding for national service programming, particularly for the ACC, has bipartisan support. 53% of likely voters say that national service programming can help communities face climate-related issues.


On the other hand, 53% of Americans also feel that the federal government doesn’t take into account “the interests of people like them.” ACC programming, like what Maine’s Climate Corps is doing in rural areas, can help reach communities and build support among Americans for government programs that can be at times met with hostility.


For example, in Maine, the small and politically conservative town of Dover-Foxcroft applied for and was approved to host a Maine Service Fellow (part of the Maine Climate Corps network) to help the local climate action committee to obtain funding for and implement energy efficiency programs. The fellow, a recent graduate from a local college, helped Dover-Foxcroft’s new warming/cooling emergency shelter create policies, organized events on conversations about climate change, wrote a report about how the county will be affected by climate change, and recruited locals at the Black Fly Festival to participate in energy efficiency programs.


Like the Maine Service Fellows, Resilient Communities Corps members will be integral members of the communities in which they serve. They will gather essential information about their communities and provide feedback from the ground on what is working and what areas need improvement or are not being adequately addressed. This information can be passed up to the interagency working groups that can then be relayed to colleagues administering the grants, improving information flow, and creating feedback channels to better craft and implement policy. It also presents the opportunity for representatives of those agencies to directly reach out to those communities to let them know they have been heard and proactively alert residents to any changes they plan on making.

Ensuring the Next Generation of STEM Talent through K–12 Research Programming

Labor shortages persist in the United States in a variety of STEM (science, technology, engineering, and mathematics) fields. To address these shortages, the next administration should establish a national, federally funded initiative involving the public and private sectors to develop a more robust and diverse pipeline of STEM talent. The Next Generation of STEM Talent Through K–12 Research Programming Initiative will remove significant barriers to participation in STEM careers through enhanced K–12 STEM programs such as science fairs and robotics competitions, as well as through strengthened federal support for teacher training to actively engage K–12 students in STEM research.

Challenge and Opportunity

Need for a Stronger STEM Pipeline in the United States

The 2024 Federal Strategic Plan for Advancing STEM Education and Cultivating STEM Talent from the National Science and Technology Council (NSTC) notes that “The United States must “inspire, educate, train, and innovate in STEM fields and STEM careers, so that through unparalleled access and opportunity, the nation can leverage the full potential of its STEM talent and ensure the country’s national security, economic prosperity, and global competitiveness.” Indeed, a vigorous domestic STEM workforce that innovates quickly to confront national challenges is a central driver for economic growth. Yet while the number of degrees awarded in STEM fields has increased since 2000 in the United States, labor shortages persist in certain fields requiring STEM degrees. These fields include computer science, data science, electrical engineering, and software development.

Fostering STEM talent across the country “is critical both to enable all individuals to achieve their own aspirations in STEM fields and careers and to ready the nation to pursue new opportunities.” Yet, the rest of the world is outpacing the United States when it comes to upper-level STEM education. The United States awarded nearly 800,000 first university degrees (i.e., associate’s and bachelor’s degrees) in science and engineering (S&E) in 2016. However, the European Union (EU) top six  countries (France, Germany, Italy, Poland, Spain, and the U.K., then part of the EU) produced more than 700,000 equivalent degrees—and China 1.7 million (in 2015)—around the same timeframe. In 2020, the United States came in third in terms of the most first university degrees in science and engineering (900,000), lagging behind nations such as India (2.5 million) and China (2 million).

The data are more complex but equally worrisome at the doctorate level. As of 2019, the United States no longer awards the largest number of science and engineering (S&E) doctoral degrees of any country. It was surpassed by China, with the United States awarding 42,000 and China awarding 43,000 that year. Comparisons of doctoral-degree production in the United States with doctoral-degree production in other nations need to account for the fact that a substantial number of U.S. S&E doctorate recipients are students on temporary visas. However, many of these doctorate recipients stay in the United States for jobs after obtaining their degrees. Moreover, the United States also lags peer nations when it comes to the percentage of S&E doctorates awarded out of all doctorates awarded. This figure is 44% for the United States, behind China (nearly 60%), Sweden (55%), Taiwan (53%), India (50%), and the U.K. (48%).

We as a nation must prepare by strengthening the STEM pipeline and closing the gap between demand for and supply of STEM talent. This effort must also focus on creating a diverse and inclusive STEM talent pool. Only by drawing on the talents of all its citizens can the United States effectively maintain and grow the national innovation base that supports key economic sectors. This broader participation in STEM “fosters closer alignment between societal needs and research, enhances public understanding and trust in science, facilitates uptake of research results throughout society, and supports evidence-based policymaking.”

If the United States is to keep pace and ensure continued innovation and prosperity, it must up its game on STEM education and training. Because of the time and training required to become a scientist or engineer, this effort must begin without delay. The COVID-19 pandemic emphasized the need for a robust STEM workforce. Scientists raced to discover more about the virus itself and its impact, as well as to develop vaccines and treatments safely and in record time. Engineers designed new equipment and ways to manufacture needed personal protective equipment (PPE) and ventilators. Computer scientists, statisticians, epidemiologists, and big-data scientists collaborated to make sense of pandemic data and model outcomes to inform public-health policies. Similar crises will inevitably arise in the future. 

Engaging Learning Experiences with Well-Trained Educators are Even More Important Because of Pandemic Learning Losses 

The coronavirus pandemic led to a significant disruption in K-12 education. Even with students back in classrooms, the negative impact of this disruption is clear and will have myriad effects on the STEM talent pipeline into the future.

Chronic absenteeism nationwide (based on students missing at least 10% of a school year) surged from 15% in 2018 to 28% in 2022, showing that post-pandemic school attendance has reduced test scores. Student attendance is instrumental to their success. As absenteeism increased, test scores declined. 

This standardized test score decline is seen across the globe where middle and high school students are still struggling academically in the years since the start of the pandemic. The Program for International Student Assessment, taken by 15-year-olds, found record decreases in scores between 2018 and 2022, where math scores decreased by 15 points and reading scores by 10 points. When students have fewer math skills, it reduces the number of students likely to become STEM experts, which narrows the pool of future scientists and engineers.

Students experienced years of learning loss, along with disruption to their social and emotional development. When compared to peer nations, U.S. children are not equipped with the high-level reading, math and digital problem-solving skills needed for the fastest-growing jobs especially in a global economy that is highly competitive. The most vulnerable students are also the most negatively impacted. Gaps already present in 2019 between high-poverty and higher-income school districts increased during the pandemic and have not closed.

Launching the Next Generation of STEM Talent Through K–12 Research Programming Initiative

The next administration should launch the Next Generation of STEM Talent Through K–12 Research Programming Initiative, coordinated by the White House Office of Science and Technology Policy (OSTP) through a working group of federal agency representatives, to strengthen the STEM pipeline in the United States. The initiative would provide an additional $25 million per year for 10 years to select agencies to support K–12 research programs (such as science fairs and robotics competitions) that inspire critical thinking and encourage young people to pursue STEM careers. The new funds would also be used to train educators and community- based scientists to become K–12 research mentors, expand research programs at the local and national levels, and build an interagency tracking mechanism to coordinate and evaluate the success of these programs. These activities directly support the five interdependent pillars outlined in the Committee on STEM Education (CoSTEM) 2024 Federal Strategic Plan for Advancing STEM Education and Cultivating STEM Talent:

Since almost 16% of the 2.1 million federal employees in the United States occupy a STEM position, this initiative would directly benefit the Federal Government—and, by extension, U.S. civil society. Students and educators involved with this initiative would increase their awareness of Federal Government STEM occupations and develop a mental contract with participating U.S. agencies that will impact future career choices. This initiative should also involve the private sector, as many companies and their trade associations are also in need of STEM talent and lead programs that the initiative could leverage. In 2021, out of 146.4 million people ages 18 to 74 working in the United States, 34.9 million (24%) were in STEM occupations. Only the federal government has the resources and infrastructure to undertake and coordinate this public-private partnership.

Inclusivity is an indispensable aspect and opportunity of this new initiative. To foster development of STEM skills, the 2023 Progress Report on the Implementation of the Federal Science, Technology, Engineering, and Mathematics (STEM) Education Strategic Plan emphasized that “the nation must engage in a collaborative effort to ensure that everyone has access to high quality STEM education throughout their lifetimes.” Access to STEM education and representation in STEM fields is unequally distributed in the United States. Women, differently abled persons, and three ethnic or racial groups—Blacks or African Americans, Hispanics or Latinos, and American Indians or Alaska Natives—are significantly underrepresented in science and engineering education and employment. In 2021, a greater share of men (29%) than women (18%) worked in STEM occupations, even though men and women represented similar proportions of the total workforce (52% men and 48% women). Similarly, Blacks/African Americans and Hispanics/Latinos make up about 28% of the overall population but only 13% of the STEM workforce. Research suggests there are many individuals—especially women, minorities, and children from low-income families—who would have developed highly impactful inventions had they been exposed to innovation in childhood. The Next Generation of STEM Talent Through K–12 Research Programming Initiative is designed to help find those “lost Einsteins”. 

There also will be an emphasis placed on rural students who do not have adequate mentors and educational systems currently in place. Studies have shown that underserved minority and rural communities often do not have access to the same educational opportunities as more affluent white communities, and this impacts the careers they will pursue. The pandemic exposed the enormous gaps between the country’s poorest and wealthiest schools around access to basic technology and live remote instruction, as well as the percentages of students who teachers report were not logging in or making contact.

The Federal Strategic Plan for Advancing STEM Education and Cultivating STEM Talent cites one of its pillars as STEM Research and Innovation Capacity. Informal learning, especially participation in research programs such as science fairs or robotic competitions, is one way to inspire critical thinking in young people and foster long-term interest in STEM. Research funded by the National Science Foundation shows that participating in a science research project increases student interest in STEM careers. These competitions provide students with opportunities to create solutions to real-life problems, encouraging innovation, which is a critical component of economic growth and entrepreneurial talent development.

There is flexibility in how opportunities are delivered to students. When schools were shut down in 2020-2021, the Society for Science converted its STEM Research Grants program, an opportunity for teachers to receive up to $5,000 for classroom resources and/or transportation to research sites, to include STEM Research kits full of resources that students were able to bring home to complete STEM research outside of school. The Society for Science has continued to provide home and school options for the resources teachers receive from this program. Relatedly, the Society for Science launched a new Research at Home website to support this work.

No matter if the vehicle for delivery is from educators providing materials to be used at home or at school, success in this area requires training teachers to be effective research mentors.  In line with CoSTEM’s Federal Objective for Training STEM Educators, an excellent prototype for such training is the Research Teachers Conferences run by the Society for Science. The Research Teachers Conferences convene high-school and middle school STEM research teachers annually to share best practices, troubleshoot challenges, and establish a network of support for each other. Nearly 2,000 teachers each year request the opportunity to attend these conferences, but funding for 2024 was only available for 275—highlighting the pent-up demand for STEM research training. More training is also needed to help professional scientists become more effective research mentors for K–12 students, and they, too, need training to ensure optimal effectiveness. The Next Generation of STEM Talent Through K–12 Research Programming Initiative is designed to train a collaborative community of K–12 research mentors working throughout the United States.

There are already many hands-on programs designed to increase the STEM talent pool by providing research-based and problem-solving learning opportunities to K–12 students: especially underrepresented minorities, girls, or students from rural communities. These programs range in size from small to large and in scope from local to federal. Programs are run by institutions such as nonprofit organizations, colleges and universities, scientific societies, and even industry trade associations. For example, the American Chemical Society has provided economically disadvantaged high-school students with paid summer-research internships for more than 50 years. Students participating in the internship program work under the guidance of professional scientists who have been trained to be research mentors. The Society for Science’s Advocate Program provides mentors to support underserved students in submitting research projects to science competitions. Funding for these types of K–12 STEM programs comes from a myriad of sources, including philanthropic foundations and individuals, companies, and local, state, and federal governments. But there is currently no widespread coordination among these programs or sharing of best practices. There is also little rigorous evaluation to determine program success. The Next Generation of STEM Talent Through K–12 Research Programming Initiative will provide leadership to align complementary efforts and additional funding to support assessment and scale-up of practices proven effective.

Only the federal government has the ability to accomplish the three objectives outlined above. But as the 2024 STEM Plan states, “the federal government alone cannot produce the STEM talent needed for the entire country. Multi-agency and multi-sector partnerships and ecosystem development, including with international counterparts, are necessary to achieve a vision for STEM in America.”  

Plan of Action

The Next Generation of STEM Talent Through K–12 Research Programming Initiative should have four major components:

Component 1. White House leadership, coordination, tracking, and evaluation

The next president should sign an Executive Order (EO) launching a national Next Generation of STEM Talent Through K–12 Research Programming Initiative led by the White House Office of Science and Technology Policy (OSTP). The initiative would oversee and strengthen federal support for teacher training and program development designed to actively engage students in STEM research and problem-solving. 

The EO should also establish an OSTP-led working group like the Committee on STEM Education (CoSTEM), the NSTC group that wrote Charting a Course for Success: America’s Strategy for STEM Education. CoSTEM – with its mandate to review STEM education programs, investments, and activities, and the respective assessments of each, in federal agencies to ensure that they are effective – serves as a model for this initiative. While CoSTEM coordinates the interagency working groups focused on different aspects of STEM, particularly the Interagency Working Group to Engage Students where Disciplines Converge (IWGC) and the Interagency Working Group to Develop and Enrich Strategic Partnerships (SP-IWG), this new working group would coordinate relevant activities across federal agencies and their subunits, with the goal to gather the leading scientists, administrators and educators doing this work outside of federal agencies, leveraging the organizational power of the federal government to provide the resources and infrastructure to coordinate this public-private partnership.

While some federal agencies already have directly relevant programs in place, other agencies could help identify offices and programs essential to the initiative’s success. The working group should issue an open call for nonprofit organizations with expertise in research-based STEM learning and teacher/mentor training to participate as advisors to the working group. The working group could also include representatives from existing programs that help expand research-based and problem-solving STEM experiences at the K–12 level. The EO should task the working group with developing a strategic national action plan that includes metrics to monitor the initiative’s success, as well as with creating a centralized database that can track, monitor, and evaluate programs funded by the initiative. The working group should periodically report to the Executive Office of the President on the initiative’s progress.

Overall goals of the initiative would be to:

  1. Ensure an abundance of qualified applicants from a variety of backgrounds—including variety in gender, race, or socioeconomic status—for all STEM jobs in the United States.
  2. Train teachers to provide students with research-based STEM education opportunities throughout their K–12 education experiences
  3. Create a comprehensive database to track programs (and their participants) aligned with and/or funded by the initiative.
  4. Rigorously and fairly evaluate programs aligned with and/or funded by the initiative, quickly communicating evaluation findings in ways that help programs adjust to best serve students and educators.

Quantitative targets to assess progress towards these goals include:

  1. Improving the extent to which demographics of applicants to STEM jobs in the United States reflect demographics of the United States as a whole.
  2. Availability of project-based STEM learning at publicly funded K–12 schools, as well as student access to opportunities (e.g., science fairs) where they can share the results of their work.
  3. Grow the pool of qualified STEM research educators to 100,000 in the next 10 years, so that all schools have access to the needed number of trained educators.

Component 2. Federal budget commitments

A few agencies—such as the National Aeronautics and Space Administration (NASA), the National Security Agency (NSA), and the Department of Defense (DoD)—currently directly support aspects of this initiative. Yet at least 20 federal agencies (full list found in FAQ) and their subunits have a clear stake in developing the STEM workforce and hiring STEM graduates. 

Each of these federal units will need dedicated funding to support the initiative, including by:

We estimate that an average allocation of $25 million per year for 10 years per relevant federal unit would be sufficient to get the initiative off the ground. These funds alone are not enough to develop the STEM workforce to the level needed in the United States. However, consistent federal funding for K–12 research programming (and associated teacher training) would provide a solid foundation for addressing the shortfalls outlined at the beginning of this memo. To maximize the initiative’s impact, additional funding should be allocated specifically for coordination and evaluation. Evaluations should be carried out every few years, and findings used to inform funding priorities and program structure as needed. Emphasis should be placed on allocating funds to expand access to high-quality STEM experiences for underserved and underrepresented students.

Component 3. Meaningful agency participation

The working group will identify existing federal programs that could be expanded to achieve the initiative’s goal. The working group will also identify agencies that have relevant missions but currently lack relevant programs.

Component 4. Partnership with non-federal organizations to provide programmatic content and complementary actions

The working group should partner with third-party organizations that already offer programs and resources (financial and in-kind) relevant to the initiative. These include but are not limited to:

The working group itself should aim to have representatives from underrepresented groups in STEM to ensure a wide variety of voices are represented as part of the leadership of this initiative. 

The next administration can use the power of the federal government to help such third-party organizations scale up and strengthen programs that have already proven effective, resulting in more teachers and scientists trained and more K–12 students able to participate in science and engineering research projects.

Precedents

The initiative outlined in this memo can and should build on multiple outstanding federal precedents. One example is the DoD’s Defense STEM Education Consortium (DSEC). The DSEC is a collaborative partnership among academia, industry, nonprofit organizations, and government that aims to broaden STEM literacy and develop a diverse and agile workforce with the technical excellence to defend our nation. Many smaller federal programs provide teacher training in various STEM fields. The next administration should leverage and potentially refocus such existing programs to emphasize critical-thinking skills and research-based programs at the K–12 level.

Conclusion

The next administration should seize the opportunity to reinvigorate the STEM talent pool in the United States by creating the Next Generation of STEM Talent Through K–12 Research Programming Initiative. The initiative will motivate participation in STEM careers by making participation in hands-on STEM research and problem-solving opportunities a standard component of K–12 education. Failure to replenish and grow our domestic STEM talent pool will lead to a decline in national innovation and economic progress and an inability to meet the moment in future times of challenge, such as a next pandemic. Only the federal government can address this need at the scale and pace needed.

Inclusivity is an indispensable aspect of this initiative. Building a robust STEM workforce in the United States requires us as a nation to draw on the talent of all Americans. The Next Generation of STEM Talent Through K–12 Research Programming Initiative will rediscover our country’s ”lost Einsteins”: the underrepresented minorities, women and underserved students from rural communities who have the capacity to deliver transformative contributions to STEM if only they were provided opportunities to do so.

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 does this idea complement existing actions already undertaken by the federal government?

The current and previous administrations have taken multiple actions that serve as a foundation for achieving the goals of Ensuring the Next Generation of STEM Talent Through K-12 Research Programming. “Agencies across the federal government are united in their commitment to developing STEM talent so that all individuals and communities can grow, aspire, and thrive, allowing the United States to reach its full potential.” While there are groups within the Federal government that are doing similar work, like the Committee on STEM Education (CoSTEM) with its mandate to review science, technology, engineering, and mathematics (STEM) education programs, investments, and activities, and the respective assessments of each, in federal agencies to ensure that they are effective, this initiative is unique in that the main leadership would be a coalition of leaders and organizations outside of the government, with a government agency like OSTP coordinating, rather than CoSTEM’s focus on interagency working groups (IWGs). CoSTEM serves as a model, with the goal to gather the best of the best who are doing this work outside of federal agencies and leverage the organizational power of the government to provide the resources and infrastructure to coordinate this public-private partnership.

What other federal initiatives can we use as a model of effective collaboration?

An outstanding example of a federal initiative that works is DoD STEM’s Defense STEM Education Consortium (DSEC). Aligned to the Federal STEM Education Strategic plan, the Defense Science, Technology, Engineering, and Mathematics Education Consortium (DSEC) is a collaborative partnership among academia, industry, non-for-profit organizations, and government that aims to broaden STEM literacy and develop a diverse and agile workforce with the technical excellence to defend our Nation. By addressing and prioritizing critical STEM challenges, DoD is investing in evidence-based approaches to inspire and develop the Nation’s science and technology workforce.


This multi-year effort includes elements focused on STEM enrichment programs for students and educators, STEM workforce engagement, program evaluation, and public outreach. These efforts will allow DoD to improve access for students to pursue STEM careers and consider Defense laboratories as a place of employment. Through strategic investment in STEM education and outreach activities, the effort will provide students with more exposure to educational and career opportunities, as well as DoD research. The program includes scholarships, internships/apprenticeships, teacher training, and conferences.

Are there existing programs under federal agencies that would benefit from the coordination proposed by the Next Generation of STEM Talent Through K–12 Research Programming Initiative?

Yes. One example that could be adapted for K-12 are the existing programs funded by the National Science Foundation, which provides summer research experiences nationally and internationally to college students. Those programs involve partnerships with universities and non-for-profit scientific societies.


In 2022, the Department of Education launched its YOU Belong in STEM initiative to strengthen STEM education nationwide by implementing and scaling high-quality PreK through university STEM education for all, which is well aligned with the goals of this proposal. Similar programs exist in many other federal agencies, but they are not coordinated nor specifically directed to building the STEM pipeline.

Is there another agency in the Federal Government besides the White House Office of Science and Technology Policy that makes sense to coordinate this effort?

Although OSTP is the obvious coordinating group, in the event it could not undertake a project of this size, the National Science Foundation in concert with the Department of Education, given its YOU Belong in STEM initiative, would be an appropriate coordinator.


A few agencies—such as the National Aeronautics and Space Administration (NASA), the National Security Agency (NSA), and the Department of Defense (DoD)—currently directly support aspects of this initiative. Yet at least 20 federal agencies and their subunits have a clear stake in developing the STEM workforce and hire STEM graduates.

Since there are so many organizations in the private sector noted in the proposal doing similar types of programs, why should the federal government step in?

While there are dozens if not hundreds of organizations doing similar types of programs, they are underfunded, uncoordinated, and under-evaluated. They are not uniformly distributed throughout the U.S., and their goals are also diffuse. Only the federal government is positioned to create the umbrella to coordinate such programs, track them, and evaluate them.

If $250 million of funding is not available, what would a less ambitious version of this proposal look like?

The OSTP working group would need to prioritize the number of federal agencies and choose those that have the most at stake from this proposal—agencies that specifically need STEM workforce to carry out their mission. Narrowed in this way, the number of units might drop by 50%, from 20 to 10. The working group could also focus on those agencies that currently have robust programs in the same space and build on those. For example, more money might be given to the DSEC program.


In addition, funding should be continued and increased for the National Science Foundation to evaluate these programs from a rigorous viewpoint to determine whether they are succeeding. Continued funding would be dependent on the results of these evaluations.

An Innovation Agenda for Addiction: Breakthrough Medicines That Scale

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.  

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.

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.

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.