Extreme heat is the leading cause of weather-related deaths in the United States and has been for the past 30 years. Low-income communities and many other vulnerable populations are disproportionately affected by heat risk. As the climate continues to warm, the threat to public health will correspondingly increase. Through a presidential directive, the White House Climate Policy Office (WHCPO) should establish the National Moonshot to Combat Extreme Heat, an all-of-government program to harmonize and accelerate federal efforts to reduce heat risk and heat illness, save lives, and improve the cost-effectiveness of federal expenditures. 

The goals of the Moonshot are to:

1. Reduce heat deaths by 20% by 2030, 40% by 2035, and 60% by 2050. 
2. Build 150 heat-resilient communities by 2030 by facilitating access to funding and uplifting social infrastructure actions prioritizing at-risk, vulnerable populations.
3. Increase visibility and awareness of federal efforts to protect residents from extreme heat. 

The Moonshot will be overseen by a new, high-level appointee at WHCPO to serve as the Executive Officer of the White House Interagency Work Group on Extreme Heat (WHIWG). 

Challenge and Opportunity

The threat to public health and safety from extreme heat is serious, expansive, and increasing as the planet continues to warm. According to Heat.gov, “Extreme heat has been the greatest weather-related cause of death in the U.S. for the past 30 years — more than hurricanes, tornadoes, flooding or extreme cold.” The number of deaths from extreme heat is difficult to accurately determine and is frequently undercounted. More recently, during the Heat Dome of 2021, the state of Washington reported 1,231 heat deaths in just one month. Further, heat-related illness includes a broad spectrum of diseases, from mild heat cramps to life-threatening heat stroke. Heat exposures have been linked to mental health illnesses and adverse birth outcomes, such as preterm births and low birth weights. Extreme heat disproportionately impacts marginalized people, including those that are low-income, BIPOC, seniors, veterans, children, the unhoused, and those with compromised health status, among others. All heat illnesses and deaths are considered preventable.

Extreme heat is an all-of-society problem that requires an all-of-government response. As the frequency, intensity, duration, and breadth of heat waves have increased dramatically over the past four years, officials and leaders at all levels have begun taking action. 

The federal government has launched new programs for addressing extreme heat over the last few years as heat waves have become a front-page issue. Recent programs initiated by the Biden Administration are providing a variety of resources and increasing awareness of this threat. Key examples are:

• The White House Interagency Work Group on Extreme Heat (WHIWG) on Extreme Heat was launched in September 2021 to coordinate a “holistic” response. The WHIWG began work with the National Integrated Heat Health Information System (NIHHIS) to develop a National Heat Strategy in July 2023. Information about the WHIWG is primarily communicated to the public through press releases from the White House. The initiative announced several new actions to address heat, including a rulemaking process at the Occupational Safety and Health Administration (OSHA) to develop a workplace heat standard and actions and ongoing data collection efforts (i.e., syndromic surveillance and heat island mapping campaigns) by the Centers for Disease Control and Prevention (CDC) and NIHHIS. The White House also announced a new set of planning tools to address extreme heat in April 2023 as part of the American Rescue Plan.

• In addition to working with the WHIWG, NIHHIS collaborates with the CDC and over 20 other federal agencies through Heat.gov, a resource hub for federal extreme heat and health information. NIHHIS focuses on developing and sharing information and tools, increasing interagency coordination, and developing a National Heat Strategy. 

• The National Climate Resilience (NCR) Framework takes a high-level approach to building climate resilience through six overarching objectives. However, detailed treatment of extreme heat in the Framework is minimal. 

Actions are needed to remedy the deficit in attention to extreme heat by uplifting the role of extreme heat in the federal response to climate impacts and give greater emphasis to social infrastructure actions. 

Several bills to address extreme heat through federal legislation have been introduced in Congress, though none have advanced. Most notable are:

1. S. 2645: Senator Edward Markey’s Preventing HEAT Illness and Deaths Act of 2023 would authorize NIHHIS to prescribe actions and provide funding. 
   
2. HR 3965: Representative Ruben Gallego’s “Extreme Heat Emergency Act of 2023” would amend the Stafford Act by adding “extreme heat” as a natural disaster for which response aid is authorized.
   
3. H.R. 2945: Representative Ruben Gallego’s Excess Urban Heat Mitigation Act of 2023” would require the Department of Housing and Urban Development (HUD) to establish a grant program to fund activities to mitigate or manage heat in urban areas. The Senate version of this bill, S. 1379, is led by Senator Sherrod Brown.

Even with this momentum, actions are dispersed across many departments and agencies. Plus, many local and state governments tend to apply for federal funding on a program-by-program, agency-by-agency basis and must navigate a complicated landscape with limited funding explicitly earmarked for heat resilience. Further, most “infrastructure” and capacity-building funding is based on mitigating or restoring economic loss of property, leading to financial relief that has gone primarily to built infrastructure and natural infrastructure projects. Communities need social infrastructure: social cohesion, policy and governance, public health, communications and alerts, planning, etc., to respond to extreme heat. This requires a pathway for communities to access funds to combat extreme heat in a comprehensive and coordinated way and bring social infrastructure actions up to a level equal to built and natural infrastructure interventions. 

There is a need to improve the coordination of heat actions across the federal government, align heat resilience activities with Justice40 mandates, and promote community-based interventions to reduce heat deaths. A National Moonshot to Combat Extreme Heat can do this by leveraging several new community-focused programs to accelerate the protection of at-risk populations from heat-related death and illness. The challenge, and therefore the opportunity, for the Moonshot is to identify, integrate, and accelerate existing resources in a human-centric framework to reduce preventable deaths, promote cool and healthy communities, and deliver value nationwide. 

Plan of Action 

The WHCPO should appoint a new Deputy Director for Heat to serve as the Executive Officer of the WHIWG and coordinate the National Moonshot to Combat Extreme Heat – an all-of-government program to accelerate federal actions to address extreme heat. The goals of the Moonshot are to:

1. Reduce heat deaths by 20% by 2030, 40% by 2035, and 60% by 2050; 
   
2. Build 150 heat-resilient communities by 2030 by facilitating access to funding and uplifting social infrastructure actions prioritizing at-risk, vulnerable populations. Social infrastructure encompasses a variety of actions in four categories: social cohesion, policy, communications, and planning.  Social infrastructure centers the needs of people in resilience.  This target aligns with the U.S. goal to reduce greenhouse gas emissions by 50% by 2030. 
   
3. Improve visibility and awareness of federal efforts to protect residents from extreme heat.

The Moonshot will capitalize on existing policies, programs, and funding and establish a human-centric approach to climate resilience by uplifting extreme heat. The Moonshot will identify and evaluate existing federal activities and available funding, including funds from the Inflation Reduction Act (IRA) and the Bipartisan Infrastructure Law (BIL), as well as agency budgets, including Federal Emergency Management Agency’s funding for the Building Resilient Infrastructure and Communities (BRIC) and the Hazard Mitigation Grant Program (HMGP). The Moonshot will integrate actions among the many existing programs dispersed across the government into a well-coordinated, integrated inter-agency initiative that maximizes results and will support cool, safe, and healthy communities

Recommendation 1. Enhance the visibility, responsibility, and capacity of the WHIWG. 

Signaling high-level support through a presidential directive, the WHCPO should appoint a Deputy Director for Heat as the Executive Officer of the WHIWG to lead the Moonshot. Two additional staff positions will be established to support the assessment, stakeholder engagement, and planning processes. The WHIWG and the Deputy Director will design and implement the Moonshot working with the Department of Health and Human Services Office of Climate Change and Health Equity. A lead contact will be designated in each agency and department participating in the NIHHIS program. 

Recommendation 2. Assess and report current status. 

The Moonshot should identify, evaluate, and report on existing programs addressing heat across the federal government, including those recently launched by the White House, to establish a current baseline, identify gaps, and catalog opportunities for integration within the federal government. The Moonshot will generate a database of existing programs and a budget cross-cut analysis to identify current funding levels. The report will incorporate the NIHHIS Extreme Heat Strategy and identify existing funding opportunities, including those in the IRA, Bipartisan Infrastructure Law, and agency programs. The Moonshot will also work with CDC and NIHHIS to develop a method to identify heat deaths to establish a baseline for tracking progress on the goals. 

Recommendation 3. Build broad community support.

The Moonshot should convene conversations and conduct regional extreme heat workshops with state, local, and tribal government personnel; external experts and stakeholders; Justice40 community leaders; professional associations; private sector representatives; and philanthropies. Topics should span the spectrum of social infrastructure, including social cohesion, public health, insurance, infrastructure, communications, and more. Based on input, the Moonshot will establish an advisory committee of non-government participants and develop pathways to connect stakeholders with federal community-focused climate resilience programs, including the White House’s Justice 40 program, EPA’s Environmental Justice Thriving Communities Technical Assistance Centers Program, and the Department of Transportation’s Thriving Communities Network, and other relevant federal programs identified in Recommendation 2. The Moonshot would add extreme heat as a covered issue area in these programs.

Recommendation 4. Make a plan.

The Moonshot should expand upon the NIHHIS Extreme Heat Strategy and make a heat action plan uplifting human health and community access to harness the potential of federal heat programs. The plan would assign roles, responsibilities, and deadlines and establish a process to track and report progress annually. In addition, the Moonshot would expand the NCR Framework to include an implementation plan and establish a human-centric approach. The Moonshot will evaluate co-benefits from heat reduction strategies, including the role cool surfaces play in protecting public health while also decreasing smog, reducing energy use, and solar radiation management. And, consistent with the Biden Administration’s 2025 priorities, the Moonshot will support research and development on emerging technologies such as microfiber fabrics that keep people cool during heat waves, temperature-sensitive coatings, and high-albedo reflective materials that can reduce the need for mechanical air-conditioning. Innovation is especially needed related to resurfacing the nation’s aging roadways.

The Moonshot will also include a communications plan to increase awareness of federal programs and funding opportunities to combat extreme heat. This should all be in place in nine months to prepare for the FY 2026 budget. The NIHHIS and CDC will develop an enhanced method for improving the accuracy of tracking heat deaths. 

Recommendation 5. Connect with people and communities.

The Moonshot should emphasize social infrastructure projects and facilitate access to funding by establishing a centralized portal for comprehensive local heat action planning and programs. The Moonshot will help build cool, safe, healthy communities by integrating heat into federal climate equity programs and supporting local heat plans and projects that reflect community input and priorities. Local heat plans should be comprehensive and integrate a suite of actions that emphasize social infrastructure and include built infrastructure and natural infrastructure. 

Recommendation 6. Initiate all-of-government action.

The Moonshot will catalyze the implementation of the plan across the government, including all the agencies and departments identified in Recommendation 1. It will establish the grant portal to enhance access to federal resources for heat-related projects for state, local, tribal, and territorial governments, and community groups. It will launch a communications plan targeting press, social media, public employees at all levels of government, stakeholders, and more. 

Recommendation 7. Support legislation to secure long-term success 

In coordination with the White House Office of Legislative Affairs and Office of Management and Budget (OMB), the Moonshot should work with Congress to draft and support federal legislation and appropriations addressing extreme heat. Congressional authority is needed to firmly establish this human-centric approach to extreme heat. The Moonshot may recommend Congressional hearings on legislation or a Congressional commission to review the Administration’s work on heat. For example, the passage of S. 2645 would enshrine the position of NIHHIS in law. The Moonshot will help Congress fulfill its role in the all-of-government response and help empower local action. 

Costs

Using information gathered in Recommendation 2, the Moonshot will focus on capturing and directing existing federal funding, including from the IRA, BIL, agency budgets, and grant programs to uplift actions addressing extreme heat and implementing the Moonshot action plan. Initial costs should be minimal: $1 million to hire the Executive Director and two staff and to report on existing programs, funding, and agency budgets. The Moonshot will produce a budget cross-cut initially and annually thereafter and assemble a budget proposal for the WHIWG on Extreme Heat for the FY 2025 and FY 2026 budget.

The Moonshot recommendation is aligned with the OMB Budget Memo of August 17, 2023, which transmits Guidance for Research and Development Priorities for the FY 2025 Budget. The OMB priorities call for addressing climate change by protecting communities’ health and mitigating its health effects, especially for communities that experience these burdens disproportionately.

Conclusion

Extreme heat is a serious public health problem disproportionately impacting many vulnerable populations, and the threat is increasing tremendously. So far in winter 2023, more than 130 monthly high-temperature records were set across the U.S. 

The federal government has several programs addressing the threat of extreme heat in the U.S., and the WHIWG reflects the all-of-government approach needed to meet the threat. The next step is to capture the full potential of existing programs and funding by launching a focused and intensive National Moonshot to Combat Extreme Heat with quantitative goals to track and reduce heat deaths and build healthy communities. This  effort will enable state and local governments and communities, especially those disproportionately impacted by extreme heat, to more readily access federal funding to develop and implement comprehensive heat action plans. The Moonshot will reduce heat deaths, improve the quality of life in cities, and reduce economic productivity loss while increasing the visibility of federal leadership on this issue. 

With heat season 2024 beginning on April 29th, it’s essential to establish an all-of-government response to address extreme heat at all levels.

This idea of merit originated from our Extreme Heat Ideas Challenge. Scientific and technical experts across disciplines worked with FAS to develop potential solutions in various realms: infrastructure and the built environment, workforce safety and development, public health, food security and resilience, emergency planning and response, and data indices. Review ideas to combat extreme heat here.

Millions of workers are subjected to the dangers of extreme heat that increase their risk of heat-related illnesses and fatalities. Due to personal, social, and workplace vulnerabilities, workers are at even greater risk, particularly women, people who are Black or Brown, those who facing low-income challenges, and those employed by small businesses. With no mandated federal heat stress standard, there is no federal mechanism to ensure the adoption of appropriate heat stress prevention strategies and emergency procedures to protect vulnerable workers. 

Now is an opportune time to introduce a federal program to champion climate equity and justice in the workplace by assisting employers’ implementation of evidence-based heat stress management strategies and heat illness emergency procedures, particularly targeting underserved working populations who labor in the heat. This program should be supported by the Occupational Safety and Health Administration (OSHA), along with university and nonprofit partners, and funded through a private or public partnership. This effort will act on the principles of employer social responsibility, best practice recognition, increased resource allocation to vulnerable working groups, third-party auditing, and a non-retaliation reporting mechanism. This policy action, across multiple stakeholders, will proactively address the challenges posed by extreme heat and work toward creating safer, more equitable working environments for all.

Challenge and Opportunity

The average global surface temperature in 2023 was 2.12ºF above the 20^th century average, resulting in Earth’s warmest year on record. Extreme temperatures will continue to rise as the frequency, intensity, and duration of heat waves increase due to climate change. Climate change is a major public health priority that places workers who perform physical labor in the heat at higher risk, due to frequent prolonged, heavy physical exertion, layers of personal protective clothing, and exposure to environmental heat stress. This combination of factors exacerbates the level of heat stress placed on the body, leading to heat-related injuries, illnesses, and fatalities. While the Biden Administration has initiated federal action to establish a mandated heat standard, the bureaucratic process is slow, averaging around eight years. Congress is also working on addressing this issue through the consideration of a bill for the adoption of an emergency temporary standard. Although it offers a quicker solution, it has a limited life span of approximately six months. Moreover, in anticipation of mandating a federal heat stress standard, there is limited infrastructure to support the adoption of evidence-based heat stress management strategies to protect workers in high-temperature environments. The current enforcement solution, OSHA’s National Emphasis Program on outdoor and indoor heat hazards, has several limitations, include such as a vague definition of noncompliant following heat hazard inspection, and uses assessment tools such as Heat Index, which is not considered “best practice.” 

To address these limitations, key stakeholders from academic settings, large research institutes, and nonprofit organizations have developed evidence-based best practices to protect vulnerable workers from extreme heat. Unfortunately, there is no system in place to determine how well companies are prepared for extreme heat. The urgency of adopting evidence-based heat stress management strategies across industries cannot be overstated, as heat-related injuries and fatalities are entirely preventable with the implementation of appropriate prevention strategies and emergency procedures.

There is a critical opportunity to champion climate equity and justice to safeguard laborers from the dangers of extreme heat. Laborers from vulnerable demographics who engage in physical work in the heat are disproportionately affected and are often not protected under evidence-based heat stress management practices by their employers. Workers with personal (e.g., age, race/ethnicity, disease status) and social (e.g., employment type, income status) vulnerabilities are exploited by working in hot environments with limited heat stress prevention strategies available to them. This form of labor exploitation during periods of high heat exposure leaves millions of U.S. workers more vulnerable to preventable heat-related injuries and fatalities. 

Small businesses and other companies with limited resources are also less equipped to protect their workforce or have the means to ensure their employees are working in safe environments in the heat. To fortify workplace resilience against extreme heat and climate change, it is imperative to equitably distribute resources for enforcing evidence-based heat policies in workplaces. Organizations with employees exposed to high temperatures must be held accountable for the effective implementation of these policies. Additionally, vulnerable workers frequently refrain from reporting unsafe conditions due to the fear of employer retaliation. Advocacy efforts become even more challenging as language barriers, food insecurity, and poverty exacerbate already dire working conditions.

The present moment presents an opportune time to introduce a program supported by occupational health and safety federal agencies. As evidence-based best practices have been developed to protect workers from extreme heat, there is no system in place to protect vulnerable working populations, allocate resources, and keep companies accountable by assessing their current heat stress management practices. OSHA and the National Institute for Occupational Safety and Health (NIOSH) are key stakeholder organizations to initiate a federal response to address the lack of adoption of heat stress management policies. However, these entities often prioritize multiple projects simultaneously, are understaffed, and benefit from partnerships with universities and nonprofits. Therefore, a cooperative approach with governing like OSHA and universities/nonprofit organizations is the appropriate strategy to create a program that promotes the enforcement of evidence-based heat protection strategies (i.e., education, hydration, heat acclimatization, environmental monitoring, physiological monitoring) at the organizational level. This approach also provides under-resourced businesses with access to basic heat protection equipment and establishes a mechanism for employees to report unsafe working conditions without fear of retaliation. This program draws inspiration from the success of the Fair Food Program, a Corporate Social Responsibility model that promotes accountability among growers, buyers, and retailers. 

This comprehensive program will support all organizations that employ workers who perform physical work in the heat, such as construction, utilities, agriculture, oil, and gas. This program will facilitate employer accountability, social responsibility, increased resource allocation, third-party auditing, and a non-retaliation reporting system. 

Plan of Action

The development and implementation of this federal program, the Occupational Heat Resiliency Program (OHRP), will require a public-private partnership between OSHA, universities, and nonprofit partners. This partnership model draws inspiration from the successful collaborative partnerships between OSHA and other partners to protect the workforce against other occupational hazards. The OHRP will promote the adoption of evidence-based heat stress management practices by targeting employers with workplaces that experience high heat exposure and/or have a large population of laborers working in the heat who are classified as vulnerable workers. The establishment of OHRP will require funding through cooperative agreements, such as the OSHA Strategic Partnership Program (OSPP). To achieve the program’s objectives, both OSHA and its partners will commit their knowledge and resources to support the program.

The program will rely on the following principles to achieve this objective:

1. Employer accountability and best practice recognition:

• Employers engaging with the proposed federal program will formalize their commitment to safeguarding workers from extreme heat through evidence-based practices derived from original research from research institutes and academic organizations. These original research sources have informed governing body recommendations from institutes such as NIOSH. 
• These commitments can be publicized, creating transparency and ensuring that products are manufactured by adequately protected workers.
• The program aims to promote the adoption of evidence-based heat practices that enhance safety, health, and productivity for the U.S. workforce.
• Recognition of best practices will facilitate widespread adoption, empowering employers, safety professionals, and workers to implement strategies and emergency procedures that effectively mitigate the risk of heat-related illnesses and injuries.

2. Climate equity through increased resource allocation:

• Recognizing the disproportionate impact of climate change on vulnerable populations, the program will allocate resources to workplaces with high percentages (>50%) of at-risk workers. This includes small businesses and workplaces with a high percentage of women, people of Color, and low-income workers. Workplace needs will be performed through existing efforts related to other occupational hazards or community projects and by targeting industries associated with increased employment of vulnerable workers. 
• Support may include assistance in creating heat stress management educational materials and emergency action plans/procedures, implementing written heat stress management plans, and providing essential resources such as hydration, shade, and cooling products.

3. Safer work environments through third-party auditing and a non-retaliation reporting system:

• Third-party audits, led by university or non-profit partners, will determine feasible evidence-based practices and resource allocations.
• Audits will employ a tier system (I, II, II) to show the level of protection that the workplace has implemented based on the presented recommendations. To ensure compliance, a non-retaliation reporting system will allow workers to report incidences where their work environment was unsafe due to extreme heat. 
• A non-retaliation reporting system will be implemented to empower workers to report unsafe conditions due to extreme heat, ensuring employer compliance and accountability. This information within the report will not be shared with employers directly, but rather through the third-party auditing entity. 

The program will be led by teams composed of OSHA representatives and university/nonprofit partners that will meet virtually regularly to ensure the goals of each principle are being met and to address any partnership issues that may arise.

Conclusion

The escalating challenges to the U.S. workforce posed by extreme heat demand proactive measures, necessitating collaboration among key government entities like OSHA alongside universities and nonprofit organizations. Currently, there is a glaring absence of mechanisms to safeguard workers who engage in physical work in the heat, particularly those from vulnerable demographics. 

To tackle this issue head-on, the establishment of OHRP funded through a private or public partnership is imperative. This initiative would champion climate equity in the workplace by expediting the adoption of evidence-based heat stress management strategies and emergency procedures. The program’s framework includes commitments from employers, recognition of best practices, increased resource allocation to vulnerable working groups, third-party auditing, and a non-retaliation mechanism. OHRP will have an immediate impact at both the federal and state level. Without the implementation of such a program, a significant portion of the U.S. workforce remains at risk of entirely preventable heat-related injuries, illnesses, and fatalities.

This idea of merit originated from our Extreme Heat Ideas Challenge. Scientific and technical experts across disciplines worked with FAS to develop potential solutions in various realms: infrastructure and the built environment, workforce safety and development, public health, food security and resilience, emergency planning and response, and data indices. Review ideas to combat extreme heat here.

Year after year, record-breaking air temperatures and heat waves are reported nationwide. In 2023, Death Valley, California experienced temperatures as high as 129°F — the highest recorded temperature on Earth for the month of June—and in July,  Southwest states experienced prolonged heat waves where temperatures did not drop below 90°F. This is especially worrisome as the frequency, intensity, and duration of rising temperatures are projected to increase, and the leading weather-related cause of death in the United States is heat. To address this growing threat, the Environmental Protection Agency (EPA) and the National Oceanic and Atmospheric Administration (NOAA) should combine and leverage their existing resources to develop extreme-heat monitoring networks that can capture spatiotemporal trends of heat and protect communities from heat-related hazards. 

Urban areas are particularly vulnerable to the effects of extreme heat due to the urban heat island (UHI) effect. However, UHIs are not uniform throughout a city, with some neighborhoods experiencing higher air temperatures than others. Further, communities with higher populations of Color and lower socioeconomic status disproportionately experience higher temperatures and are reported to have the highest increase in heat-related mortality. It is imperative for local government officials and city planners to understand who is most vulnerable to the impacts of extreme heat and how temperatures vary throughout a city to develop effective heat mitigation and response strategies. While the NOAA’s National Weather Service (NWS) stations provide hourly, standardized air measurements, their data do not capture intraurban variability.

Challenge and Opportunity

Heat has killed more than 11,000 Americans since 1979, yet an extreme heat monitoring network does not exist in the country. While NOAA NWS stations capture air temperatures at a central location within a city, they do not reveal how temperatures within a city vary. This missing information is necessary to create targeted, location-specific heat mitigation and response efforts.

Synergistic Environmental Hazards and Health Impacts

UHIs are metropolitan areas that experience higher temperatures than surrounding rural regions. The temperature differences can be attributed to many factors, including high impervious surface coverage, lack of vegetation and tree canopy, tall buildings, air pollution, and anthropogenic heat. UHIs are of significant concern as they contribute to higher daytime temperatures and reduce nighttime cooling, which in turn exacerbates heat-related deaths and illnesses in densely populated areas. Heat-related illnesses include heat exhaustion, cramps, edema, syncope, and stroke, among others. However, heat is not uniform throughout a city, and some neighborhoods experience warmer temperatures than others in part due to structural inequalities. Further, it has been found that, on average, People of Color and those living below the poverty line are disproportionately exposed to higher air temperatures and experience the highest increase in heat-related mortality. As temperatures continue to rise, it becomes more imperative for the federal government to protect vulnerable populations and communities from the impacts of extreme heat. This requires tools that can help guide heat mitigation strategies, such as the proposed interagency monitoring network. 

High air temperatures and extreme heat are also associated with poor air quality. As common pavement surfacing materials, like asphalt and concrete, absorb heat and energy from the sun during the day, the warm air at the surface rises with present air pollutants. High air temperatures and sunlight are also known to help catalyze the production of air pollutants such as ozone in the atmosphere and impact the movement of air and, therefore, the movement of air pollution. As a result, during extreme heat events, individuals are exposed to increased levels of harmful pollutants. Because poor air quality and extreme heat are directly related, the EPA should expand its air quality networks, which currently only detect pollutants and their sources, to include air temperature. Projections have determined extreme heat events and poor air quality days will increase due to climate change, with compounding detriments to human health. 

Furthermore, extreme heat is linked not only to poor air quality but also to wildfire smoke—and they are becoming increasingly concomitant. Projections report with very high confidence that warmer temperatures will lengthen the wildfire season and thus increase areas burned. Similar to extreme heat’s relationship with poor air quality, extreme heat and wildfire smoke have a synergistic effect in negatively impacting human health. Extreme heat and wildfire smoke can lead to cardiovascular and respiratory complications as well as dehydration and death. These climatic hazards have an even larger impact on environmental and human health when they occur together.

As the UHI effect is localized and its causes are well understood, urban cities are ideal locations to implement heat mitigation and adaptation strategies. To execute these plans equitably, it is critical to identify areas and communities that are most vulnerable and impacted by extreme heat events through an extreme heat monitoring network. The information collected from this network will also be valuable when planning strategies targeting poor air quality and wildfire smoke. The launch of an extreme heat monitoring network will have a considerable impact on protecting lives. 

Urban Heat Mapping Efforts

Both NOAA and EPA have existing programs that aim to map, reduce, or monitor UHIs throughout the country. These efforts may have the capacity to also implement the proposed heat monitoring network. 

Since 2017, NOAA has worked with the National Integrated Heat Health Information System (NIHHIS) and CAPA Strategies LLC to fund yearly UHI mapping campaign programs, which has been instrumental in highlighting the uneven distribution of heat throughout U.S. cities. These programs rely on community science volunteers who attach NOAA-funded sensors to their cars to collect air temperature, humidity, and time data. These campaigns, however, are currently only run during summer months, and not all major cities are mapped each year. NOAA’s NIHHIS has also created a Heat Vulnerability Mapping Tool, which impressively illustrates the relationship between social vulnerability and heat exposure. These maps, however, are not updated in real-time and do not display air temperature data. Another critical tool in mapping UHIs is NWS recently created HeatRisk prototype, which identifies risks of heat-related impacts in numerous parts of the country. This prototype also forecasts levels of heat concerns up to seven days into the future. However, HeatRisk does not yet provide forecasts for the entire country and uses NWS air temperature products, which do not capture intraurban variability. The EPA has a Heat Island Reduction program dedicated to working with community groups and local officials to find opportunities to mitigate UHIs and adopt projects to build heat-resilient communities. While this program aims to reduce and monitor UHIs, there are no explicit monitoring or mapping strategies in place. 

While the products and services of each agency have been instrumental in mapping UHIs throughout the country and in heat communication and mitigation efforts, consistent and real-time monitoring is required to execute extreme heat response plans in a timely fashion. Merging the resources of both agencies would provide the necessary foundation to design and implement a nationwide extreme heat monitoring network.

Plan of Action

Heat mitigation strategies are often city-wide. However, there are significant differences in heat exposure between neighborhoods. To create effective heat adaptation and mitigation strategies, it is critical to understand how and where temperatures vary throughout a city. Achieving this requires a cross-agency extreme heat monitoring network between federal agencies. 

The EPA and NOAA should sign a memorandum of agreement to improve air temperature monitoring nationwide. Following this, agencies should collaborate to create an extreme heat monitoring network that can capture the intraurban variability of air temperatures in major cities throughout the country.

Implementation and continued success require a number of actions from the EPA and NOAA. 

1. EPA should expand its Heat Island Reduction program to include monitoring urban heat. The Inflation Reduction Act (IRA) provided the agency with $41.5 billion to fund new and existing programs, with $11 billion going toward clean air efforts. Currently, their noncompetitive and competitive air grants do not address extreme heat efforts. These funds could be used to place air temperature sensors in each census tract within cities to map real-time air temperatures with high spatial resolution.
2. EPA should include air temperature monitoring in their monitoring deployments. Due to air quality tracking efforts mandated by the Clean Air Act, there are existing EPA air quality monitoring sites in cities throughout the country. Heat monitoring efforts could be tested by placing temperature sensors in the same locations.
3. EPA and NOAA should help determine vulnerable communities most impacted by extreme heat. Utilizing EPA’s Environmental Justice Screening and Mapping (EJScreen) Tool and NIHHIS’s Heat Vulnerability Mapping Tool, EPA and NOAA could determine where to place air temperature monitors, as the largest burden due to extreme heat tends to occur in neighborhoods with the lowest economic status.
4. NOAA should develop additional air temperature sensors. NOAA’s summer UHI campaign programs highlight the agency’s ability to create sensors that capture temperature data. Given their expertise in capturing meteorological conditions, NOAA should develop national air temperature sensors that can withstand various weather conditions.
5. NOAA should build data infrastructure capable of supporting real-time monitoring. Through NIHHIS, the data obtained from the monitoring network could be updated in real-time and be publicly available. This data could also merge with the current vulnerability mapping tool and HeatRisk to examine extreme heat impacts at finer spatial scales. 

Successful implementation of these recommendations would result in a wealth of air temperature data, making it possible to monitor extreme heat at the neighborhood level in cities throughout the United States. These data can serve as a foundation for developing extreme heat forecasting models, which would enable governing bodies to develop and execute response plans in a timely fashion. In addition, the publicly available data from these monitoring networks will allow local, state, and tribal officials, as well as academic and non-academic researchers, to better understand the disproportionate impacts of extreme heat. This insight can support the development of targeted, location-specific mitigation and response efforts.

Conclusion

As temperatures continue to rise in the United States, so do the risks of heat-related hazards, morbidity, and mortality. This is especially true for urban cities, where the effects of extreme heat are most prevalent. A cross-agency extreme-heat monitoring network can support the development of equitable heat mitigation and disaster preparedness efforts in major cities throughout the country.

This idea of merit originated from our Extreme Heat Ideas Challenge. Scientific and technical experts across disciplines worked with FAS to develop potential solutions in various realms: infrastructure and the built environment, workforce safety and development, public health, food security and resilience, emergency planning and response, and data indices. Review ideas to combat extreme heat here.

In the United States, almost one in four Americans are vulnerable to the growing threat of extreme heat. In fact, extreme heat kills more people on average every year than any other extreme weather event. Yet scientists believe these numbers still largely underestimate the true number of heat-related deaths by up to 50-fold, suggesting tens of thousands of Americans could be dying each year from heat-related exposure. Climate change further drives the risk of extreme heat, with a hundred million Americans exposed to dangerous temperatures each summer and projections showing these numbers to further increase.

The Administration for Strategic Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) can and should play a leadership role in supporting State, Local, Tribal, and Territorial (SLTT) preparedness and response to extreme heat. Just as ASPR serves as the Sector Risk Management Agency for healthcare and Public Health (HPH) cybersecurity, ASPR is uniquely positioned to lead the federal response to extreme heat due to the distinct and disproportionate impacts of extreme heat on the medical and public health sector. As leader, ASPR would support the integration of extreme heat into healthcare preparedness and response programs, participate in an interagency workgroup to develop critical healthcare impact-based forecasts, and implement lessons learned from similar efforts to develop effective hurricane responses. This is critical for ASPR to meet its mandate in a rapidly warming world, will save thousands of American lives, and stand as a testament to U.S. innovation and resolve.

Challenge and Opportunity

Across the U.S., more communities are facing the deadly impacts of extreme heat. Local responses are often disorganized and reactive, resulting in excessive preventable injuries and deaths. Hospitals are overwhelmed, emergency services are stretched thin, and the most vulnerable suffer. Combined with potential power outages, heat waves could create catastrophic impacts, including unparalleled patient surge and mass casualty crises that would overwhelm local and state resources. Unlike other extreme weather hazards, the impacts of extreme heat are disproportionately felt by HPH organizations and agencies, a clear indicator that ASPR should play a leadership role in supporting SLTTs to ensure regional healthcare readiness, sharing of critical impact-forecast data, and effective response coordination.

On June 23, 2021, the Seattle-based National Weather Service (NWS) office alerted Washington State response agencies about a large record-breaking heat dome forecasted to impact the region. With three days until the start of the heat dome and five days until its peak, there was ample time to prepare. However, with Washington being largely unaccustomed to extreme heat —and lacking plans, an understanding of the potential impacts, and technical assistance or resource support from the federal government — SLTTs were left to fend for themselves. The results were catastrophic: more lives were lost than any other extreme weather event in the state’s history.

ASPR, with minimal additional funding from Congress, should act to better support SLTT-level healthcare and public health organizations and agencies by supporting the development of data-driven decision-making tools, heat-integrated preparedness programs, and response systems ready to pre-deploy when extreme heat threatens to overwhelm SLTT HPH resources.

Heat Impact Forecasts and Response Triggers

A major operational barrier to extreme heat response planning is a lack of data-driven decision-making resources, such as impact-based forecasts. Traditional forecasts for heat waves often focus on temperature and humidity, but do little to provide necessary information for SLTTs and national agencies to understand community risk and anticipated impacts on the HPH sectors.

Similar to ongoing efforts to move beyond traditional hurricane forecasts (wind speed, pressure, location) and toward impact-based warnings for jurisdictions and communities, the Centers for Disease Control and Prevention (CDC) and the NWS collaboratively developed the HeatRisk prototype to provide risk-focused information. Even with the tool still in the development phase and only providing forecasts for half of the continental United States, HeatRisk has already been integrated into SLTT response plans. This demonstrates a significant need to complete and expand this tool to support SLTT and federal response decision-making.

ASPR is uniquely positioned to advance this initiative by integrating healthcare data to develop impact-based forecasts that provide anticipated public health and healthcare surge information. Instead of only forecasting the level of risk posed to the public, a HeatRisk HPH platform could provide critical estimates of healthcare service demand due the extreme heat. This information would be vital to identify evidence-based thresholds that could trigger pre-event coordination, technical assistance, and activation of federal resources from ASPR and FEMA. 

Heat-Prepared Medical and Public Health Response System

Extreme temperature exposure can take just hours to days to be deadly, while federal responses often take days to weeks to organize and deploy, so saving lives during an extreme heat event that overwhelms local and state HPH resources requires rapid pre-deployment of federal assets based on extreme heat forecast data. To date, there is no plan for or example of this occurring, even when thousands of Americans are dying each year from extreme heat.

Clear legal guidelines allow ASPR to pre-deploy response personnel and supplies without a disaster declaration. Section 301, 311, 2812 of the Public Health Services Act authorizes the HHS secretary to provide public health service personnel, equipment, medical supplies, and other assistance to states and local jurisdictions to prevent or respond to any health emergency, with or without a public health emergency declaration. In addition, there are many examples of ASPR pre-deploying assets in anticipation of extreme weather hazards such as Hurricane Ian in 2022, which included the pre-deployment of Health and Medical Task Force teams, Incident Management Teams, and caches of medical supplies. 

ASPR has a mission responsibility to support SLTTs before and during an overwhelming heat emergency with technical assistance and resources – such as personnel and critical medical supplies. This will require modernizing the National Disaster Medical System (NDMS) and U.S. Public Health Service (USPHS) Commissioned Corps to meet the current and future threat landscape of extreme heat, development of heat-specific response standards and training, and integration of forecast-based pre-deployment and technical assistance into regional SLTT preparedness activities. 

Additionally, heat response standards and training could support SLTT Medical Reserve Corps (MRC) volunteer heat-response capabilities through an already existing ASPR and the National Association of County and City Health Officials collaboration, which provides MRC deployment training and readiness guides. This technical support would help meet the growing demand for MRC volunteers in local extreme heat responses.

Heat-Prepared Healthcare Systems

Healthcare systems are often caught off guard by extreme heat events due to a lack of hazard analysis and preparedness. ASPR is critical in supporting healthcare readiness via the Hospital Preparedness Program (HPP), which provides funding through grants and cooperative agreements to support local healthcare capacity, system readiness, and coordination in response to medical surge events.

There is a significant opportunity to integrate heat-specific programmatic requirements into HPP, such as requiring heat-specific hazard and vulnerability analyses and preparedness activities, which would ensure health systems are aware and prepared. Additionally, advancements in medical surge coordination, such as regional and state medical operations coordination cells (MOCC), developed or refined during the pandemic and utilized during periods of extreme heat, should be funded through HPP to ensure patient and resource coordination capabilities are developed, utilized, have appropriate authority, and are financially sustained. 

Heat-Health Response Excellence Centers

ASPR has created and funded several medical-academic centers that provide technical assistance, training, exercises, and assessments specific to unique hazards and demographics. These include two Pediatric Disaster Care Centers of Excellence and the National Emerging Special Pathogens Training & Education Center. With adequate congressional funding, ASPR should establish two national Heat-Health Response Excellence Centers that support SLTTs and ASPR in identifying preparedness and response best practices; developing heat-specific federal response standards and training; understanding regional heat impact characteristics and supporting HeatRisk data integration; connecting HPH response planners with leading national heat research and subject matter experts; and leveraging ASPR TRACIE, ASPR Project ECHO, and the National Integrated Heat Health Information Network (NIHHIS) to capture and disseminate best practices and ongoing engagement.

Plan of Action

To ensure ASPR is able to advance SLTT HPH extreme heat readiness and can effectively support jurisdictions responding to a heat-related health emergencies, the following actions should be taken.

Recommendation 1. Develop heat impact-based forecasts 

1. ASPR collaborates closely with CDC and NWS to support the expansion of the HeatRisk prototype to include HPH sector risk analysis (using ASPR-controlled healthcare data), and is socialized/integrated in SLTT heat response plans. 
2. Identify specific NDMS forecast thresholds to trigger support for SLTTs, such as prepositioning of personnel, resources, and provision of technical assistance. 
3. One-time funds of $10 million to increase HeatRisk scope and impact-based forecast planning that would include:
   1. Staff support to appropriately integrate ASPR healthcare data
   2. Cross-agency integration of HeatRisk data to identify activation thresholds
   3. Outreach and promotion for SLTT awareness and planning
4. Recurring $3 million to ensure ongoing HeatRisk refinement (incorporating new data), ASPR healthcare data integration, and ongoing assistance to SLTTs to support heat response planning.

Recommendation 2. Leverage HPP to advance healthcare readiness

1. Require HPP recipients to integrate extreme heat in the required coalition-led hazard and vulnerability assessments (HVA). This should include connections with local or regional climate projection subject matter experts.
2. Require healthcare coalitions to develop a coalition heat response plan, similar to existing requirements for hazard-specific response plans, such as the radiation emergency surge annex requirement.
3. Require healthcare coalitions to use extreme heat as a Medical Response and Surge Exercise scenario once in each cooperative agreement, or more frequently based on HVA and priorities.
4. Streamline MOCC-capability funding through HPP, require all HPP recipients to establish patient and resource transfer coordination capabilities, and institute clear transfer authority. 50% increase in annual funding per recipient, or $120 million based on 2023 funding.
   1. Current funding mechanisms for MOCCs are convoluted, tied to expiring COVID funding or reallocating funds from various response funds. A clear, streamlined approach will ensure sustainability and readiness.
   2. MOCC funding should be periodically reassessed based on innovative best practices and changes in the local and national threat landscape. For example, MOCCs may be critical during non-emergency protracted hospital strain and should be funded appropriately.
5. Ensure healthcare coalitions engage outpatient healthcare, long-term care, and federally qualified health centers and their respective regional or state associations.

Recommendation 3. Establish technical assistance resources

1. Fund and establish two regional Heat-Health Response Excellence Centers at two academic institutions that will provide technical expertise and guidance to federal agencies and SLTTs on heat preparedness and response best practices, regional heat characteristics, and connect SLTTs with heat subject matter experts.
2. Develop heat-specific response guidance—examples could include heat-sensitive pharmaceutical guidance, heat-associated mass casualty triage, and critical resources for extreme heat-related patient surges. 
3. Allocate $6 million in annual funds based on existing ASPR-funded Pediatric Disaster Care Centers of Excellence. 

Recommendation 4. Modernize NDMS and USPHS for extreme heat

1. Work with Heat-Health Response Excellence Centers to develop heat-specific response standards and training. Integrate them into current NDMS modernization efforts, starting with Disaster Medical Assistant Teams.
2. Update NDMS response plans to align with forecast-based response triggers. Integrate these plans into ongoing regional exercises that include HPP recipients. 
3. One-time funds: $17 million based on 2020 CARES Act for USPHS training.

Cost Estimates

This proposal would require a first-year cost of $153 million and future annual costs of $129 million. The economic justification to fund these efforts is apparent. The sharp increase in billion-dollar extreme weather disasters in the U. S., the growing awareness of the impact of extreme heat on human health (and associated medical expenses), and mitigation research showing that every dollar in prevention saves up to $15 in response and recovery expenses should incentivize Congress to fully fund this proposal. 

Conclusion

Increasing risks associated with extreme heat in the United States signal an urgent need to enhance national preparedness and response strategies. ASPR is ideally suited to lead in supporting SLTTs in their preparedness and response. ASPR can accomplish this through low-cost measures that develop critical decision-making tools and better integrate extreme heat into existing programs, funding mechanisms, and medical and public health deployment systems.

Frontline communities bear the brunt of harms created by climate change and environmental pollution, but they also increasingly generate their own data, providing critical social and environmental context often not present in research or agency-collected data. However, community data collectors face many obstacles to integrating this data into federal systems: they must navigate complex local and federal policies within dense legal landscapes, and even when there is interest or demonstrated need, agencies and researchers may lack the capacity to find or integrate this data responsibly.

Federal research and regulatory agencies, as well as the White House, are increasingly supporting community-led environmental justice initiatives, presenting an opportunity to better integrate local and contextualized information into more effective and responsive environmental policy.

The Environmental Protection Agency (EPA) should better integrate community data into environmental research and governance by building internal capacity for recognizing and applying such data, facilitating connections between data communities, and addressing misalignments with data standards.

Details

Community science and monitoring are often overlooked yet vital facets of open science. Community science collaborations and their resulting data have led to historic environmental justice victories that underscore the importance of contextualized community-generated data in environmental problem-solving and evidence-informed policy-making. 

Momentum around integrating community-generated environmental data has been building at the federal level for the past decade. In 2016, the report “A Vision for Citizen Science at EPA,” produced by the National Advisory Council for Environmental Policy and Technology (NACEPT), thoroughly diagnosed the need for a clear framework for moving community-generated environmental data and information into governance processes. Since then, EPA has developed additional participatory science resources, including a participatory science vision, policy guidelines, and equipment loan programs. More recently, in 2022, the EPA created an Equity Action Plan in alignment with their 2022–2026 Strategic Plan and established an Office of Environmental Justice and External Civil Rights (OEJECR). And, in 2023, as a part of the cross-agency Year of Open Science, the National Aeronautics and Space Administration (NASA)’s Transform to Open Science (TOPS) program lists “broadening participation by historically excluded communities” as a requisite part of its strategic objectives. 

It is evident that the EPA and research funding agencies like NASA have a strategic and mission-driven interest in collaborating with communities bearing the brunt of environmental and climate injustice to unlock the potential of their data. It is also clear that current methods aren’t working. Communities that collect and use environmental data still must navigate disjointed reporting policies and data standards and face a dearth of resources on how to share data with relevant stakeholders within the federal government. There is a critical lack of capacity and coordination directed at cross-agency integration of community data and the infrastructure that could enable the use of this data in regulatory and policy-making processes. 

Recommendations

To build government capacity to integrate community-generated data into environmental governance, the EPA should:

• Create a memorandum of understanding between the EPA’s OEJECR, National Environmental Justice Advisory Council (NEJAC), Office of Management and Budget (OMB), United States Digital Service (USDS), and relevant research agencies, including NASA, National Atmospheric and Oceanic Administration (NOAA), and National Science Foundation (NSF), to develop a collaborative framework for building internal capacity for generating and applying community-generated data, as well as managing it to enable its broader responsible reuse.
• Develop and distribute guidance on responsible scientific collaboration with communities that prioritizes ethical open science and data-sharing practices that center community and environmental justice priorities.
• Create a capacity-building program, designed by and with environmental justice and data-collecting communities, focused on building translational and intermediary roles within the EPA that can facilitate connections and responsible sharing between data holders and seekers. Incentivize the application of the aforementioned guidance within federally funded research by recruiting and training program staff to act as translational liaisons situated between the OEJECR, regional EPA offices, and relevant research funding agencies, including NASA, NOAA, and NSF.

To facilitate connections between communities generating data, the EPA should:

• Expand the scope of the current Environmental Information Exchange Network (EN) to include facilitation of environmental data sharing by community-based organizations and community science initiatives. 
• Initiate a working group including representatives from data-generating community organizations to develop recommendations on how EN might accommodate community data and how its data governance processes can center community and environmental justice priorities.
• Provide grant funding within the EN earmarked for community-based organizations to support data integration with the EN platform. This could include hiring contractors with technical data management expertise to support data uploading within established standards or to build capacity internally within community-based organizations to collect and manage data according to EN standards. 
• Expand the resources available for EN partners that support data quality assurance, advocacy, and sharing, for example by providing technical assistance through regional EPA offices trained through the aforementioned capacity-building program. 

To address misaligned data standards, the EPA, in partnership with USDS and the OMB, should:

• Update and promote guidance resources for communities and community-based organizations aiming to apply the data standards EPA uses to integrate data in regulatory decisions. 
• Initiate a collaborative co-design process for new data standards that can accommodate community-generated data, with representation from communities who collect environmental data. This may require the creation of maps or crosswalks to facilitate translation between standards, including research data standards, as well as internal capacity to maintain these crosswalks.

Community-generated data provides contextualized environmental information essential for evidence-based policy-making and regulation, which in turn reduces wasteful spending by designing effective programs. Moreover, healthcare costs will be reduced for the general public if better evidence is used to address pollution, and climate adaptation costs could be reduced if we can use more localized and granular data to address pressing environmental and climate issues now rather than in the future. 

Our recommendations call for the addition of at least 10 full-time employees for each regional EPA office. The additional positions proposed could fill existing vacancies in newly established offices like the OEJECR. Additional budgetary allocations can also be made to the EPA’s EN to support technical infrastructure alterations and grant-making.

While there is substantial momentum and attention on community environmental data, our proposed capacity stimulus can make existing EPA processes more effective at achieving their mission and supports rebuilding trust in agencies that are meant to serve the public.

To learn more about the importance of opening science and to read the rest of the published memos, visit the Open Science Policy sprint landing page.

Every day, the executive branch of the federal government makes transformative policy changes. When federal agencies need expert input, they look to advice from external experts and interested citizens through a series of public engagement mechanisms, from public meetings to public comment. Of these, only one mechanism allows the executive branch to actively source consensus-based public advice and for external experts to directly advise policymakers, the Federal Advisory Committee Act (FACA). And it’s a law many Americans have never heard of.

FACA enables agencies to create advisory committees

Enacted in 1972, FACA governs expert and public engagement with executive branch decision making. FACA articulates rules for the establishment, operation, and termination of advisory committees (AC), groups of experts that the federal agencies establish, manage, and use to provide external advice on key policy questions. At any given moment in time, there are ~1000 active ACs across the federal government making crucial recommendations to agency leaders.

At the Food and Drug Administration (FDA), FACA is essential to the workings of the agency’s regulatory engine and public health mission. The FDA uses its ACs to provide independent advice on medical products (drugs and devices), providing a unique window for experts and the public to comment on cutting-edge medical products in the approvals pipeline. ACs capture the headlines through their “yes” or “no” votes on product approval, raising spirits or breaking hearts. Industry takes notice: medical product sponsors spend months preparing for these meetings, supported by a boutique industry geared to help them “ace” their AC meetings.

ACs need to be reformed to build public trust in the FDA

While ACs are a crucial transparency measure for an agency like FDA that is currently grappling with declining public trust, the system has been repeatedly under fire. Recent controversies include FDA’s public overruling of AC recommendations against approval for hydrocodone, an opioid pain reliever, and aducanumab, an Alzheimer’s treatment. After aducanumab approval, several high-profile resignations exacerbated the trust-issues. What’s more, FDA’s use of ACs is in decline, with the percentage of new drugs reviewed by ACs decreasing by almost 10 times from 2010-2021. These actions are in direct conflict with current whole-of-government efforts to modernize regulatory review and expand meaningful participation in the regulatory decision making process. Advancing racial equity, opening up the scientific enterprise, and broadening public engagement in regulatory decisions will require transformative policy solutions for the FDA. 

To re-envision how the FDA and other federal agencies engage external scientific experts and the public to address critical challenges facing public health, FAS is diving deep into how FACA is put into action at the FDA. Over the next year, FAS will be engaging AC members on their experiences in service, understanding key evidence needs at the agency that a reformed AC system could better meet, and scoping necessary process, regulatory, and statutory changes to the AC system. This will build upon our previous efforts: FAS has participated in and provided public comment to many AC meetings and documented how ACs are slow to respond to emerging questions of regulatory concern in our ongoing work to address bias in medical innovation. FAS has also documented strategies to improve science advice for the executive branch, including FACA reform. We invite you to follow this work and join us in calling for reforms that strengthen trust in the FDA Advisory Committee system.

Calls for systematic reform are coming from leadership across the FDA, yet consensus does not yet exist on what those reforms should look like. From recommendations to get rid of voting requirements at meetings (already receiving Congressional scrutiny), to broadening membership, including to members with conflicts of interest, to increasing review timelines of sponsor materials before meetings, there is no shortage of ideas for what this new system could look like. Non-profit leaders and academic researchers have also started coming together to make recommendations that address FDA’s influence over Advisory Committee discussions and ongoing issues with agency leadership overruling the AC’s vote. There could also be clearer requirements for the FDA to respond to AC recommendations and make set public timelines for agency action. Twenty-five Attorneys General recently called on the FDA to release updates to its actions on pulse oximetry one year after the AC meeting. 

More broadly, the FDA can learn from other agencies with explicit policies guiding their public engagement, such as the Meaningful Involvement Policy at the Environmental Protection Agency. These FDA-specific recommendations build upon long-standing calls to reform FACA to reduce the administrative barriers that make it challenging to solicit expert advice when needed or lead some agencies to forgo processes that could invoke FACA altogether.

To improve patient care, it is essential to create a nimble, participatory, and transparent process that ensures regulated products will benefit the health of all Americans. AC reform will be essential to building the FDA’s capacity to address increasingly complex regulatory science challenges, from artificial intelligence, to real-world data, to emerging platform technologies, to health inequity, while also improving the federal government’s ability to more rapidly generate consensus-based science advice. FAS is excited to play our part in strengthening evidence-based policy by engaging in policy entrepreneurship to engage stakeholders, develop roadmaps, and advocate for change. 

Summary

Countries are facing dynamic, multidimensional, and interconnected crises. The pandemic, climate change, rising economic inequalities, food and energy insecurity, political polarization, increasing prevalence of youth mental and substance use disorders, and misinformation are converging, with enormous sociopolitical and economic consequences that are weakening democracies, corroding the social fabric of communities, and threatening social stability and national security. Globalization and digitalization are synchronizing, amplifying, and accelerating these crises globally by facilitating the rapid spread of disinformation through social media platforms, enabling the swift transmission of infectious diseases across borders, exacerbating environmental degradation through increased consumption and production, and intensifying economic inequalities as digital advancements reshape job markets and access to opportunities.

Systemic action is needed to address these interconnected threats to American well-being.

A pathway to addressing these issues lies in transitioning to a Well-Being Economy, one that better aligns and balances the interests of collective well-being and social prosperity with traditional economic and commercial interests. This paradigm shift encompasses a ‘Mental Wealth’ approach to national progress, recognizing that sustainable national prosperity encompasses more than just economic growth and instead elevates and integrates social prosperity and inclusivity with economic prosperity. To embark on this transformative journey, we propose establishing an American Mental Wealth Observatory, a translational research entity that will provide the capacity to quantify and track the nation’s Mental Wealth, generate the transdisciplinary science needed to empower decision makers to achieve multisystem resilience, social and economic stability, and sustainable, inclusive national prosperity.

Challenge and Opportunity

America is facing challenges that pose significant threats to economic security and social stability. Income and wealth inequalities have risen significantly over the last 40 years, with the top 10% of the population capturing 45.5% of the total income and 70.7% of the total wealth of the nation in 2020. Loneliness, isolation, and lack of connection are a public health crisis affecting nearly half of adults in the U.S. In addition to increasing the risk of premature mortality, loneliness is associated with a three-fold greater risk of dementia. 

Gun-related suicides and homicides have risen sharply over the last decade. Mental disorders are highly prevalent. Currently, more than 32% of adults and 47% of young people (18–29 years) report experiencing symptoms of anxiety and depression. The COVID-19 pandemic compounded the burden, with a 25–30% upsurge in the prevalence of depressive and anxiety disorders. America is experiencing a social deterioration that threatens its continued prosperity, as evidenced by escalating hate crimes, racial tensions, conflicts, and deepening political polarization. 

To reverse these alarming trends in America and globally, policymakers must first acknowledge that these problems are interconnected and cannot effectively be tackled in isolation. For example, despite the tireless efforts of prominent stakeholder groups and policymakers, the burden of mental disorders persists, with no substantial reduction in global burden since the 1990s. This lack of progress is evident even in high-income countries where investments in and access to mental health care have increased. 

Strengthening or reforming mental health systems, developing more effective models of care, addressing workforce capacity challenges, leveraging technology for scalability, and advancing pharmaceuticals are all vital for enhancing recovery rates among individuals grappling with mental health and substance use issues. However, policymakers must also better understand the root causes of these challenges so we can reshape the economic and social environments that give rise to common mental disorders.

Understanding and Addressing the Root Causes 

Prevention research and action often focus on understanding and addressing the social determinants of health and well-being. However, this approach lacks focus. For example, traditional analytic approaches have delivered an extensive array of social determinants of mental health and well-being, which are presented to policymakers as imperatives for investment. These include (but are not limited to):

• Adverse early life exposures (abuse and neglect)
• Substance misuse
• Domestic, family, and community violence
• Unemployment
• Poverty and inequality
• Poor education quality
• Homelessness
• Social disconnection
• Food insecurity
• Pollution
• Natural disasters and climate change

This practice is replicated across other public health and social challenges, such as obesity, child health and development, and specific infectious and chronic diseases. Long lists of social determinants lobbied for investment lead policymakers to conclude that nations simply can’t afford to invest sufficiently to solve these health and social challenges. 

However, it Is likely that many of these determinants and challenges are merely symptoms of a more systemic problem. Therefore, treating the ongoing symptoms only perpetuates a cycle of temporary relief, diverts resources away from nurturing innovation, and impedes genuine progress.

To create environments that foster mental health and well-being, where children can thrive and fulfill their potential, where people can pursue meaningful vocation and feel connected and supported to give back to communities, and where Americans can live a healthy, active, and purposeful life, policymakers must recognize human flourishing and prosperity of nations depends on a delicate balance of interconnected systems.

The Rise of Gross Domestic Product: An Imperfect Measure for Assessing the Success and Wealth of Nations

To understand the roots of our current challenges, we need to look at the history of the foundational economic metric, gross domestic product (GDP). While the concept of GDP had been established decades earlier, it was during a 1960 meeting of the Organization for Economic Co-operation and Development that economic growth became a primary ambition of nations. In the shadow of two world wars and the Great Depression, member countries pledged to achieve the highest sustainable economic growth, employment, efficiency, and development of the world economy as their top priority (Articles 1 & 2). 

GDP growth became the definitive measure of a government’s economic management and its people’s welfare. Over subsequent decades, economists and governments worldwide designed policies and implemented reforms aimed at maximizing economic efficiency and optimizing macroeconomic structures to ensure consistent GDP growth. The belief was that by optimizing the economic system, prosperity could be achieved for all, allowing governments to afford investments in other crucial areas. However, prioritizing the optimization of one system above all others can have unintended consequences, destabilizing interconnected systems and leading to a host of symptoms we currently recognize as the social determinants of health. 

As a result of the relentless focus on optimizing processes, streamlining resources, and maximizing worker productivity and output, our health, social, political, and environmental systems are fragile and deteriorating. By neglecting the necessary buffers, redundancies, and adaptive capacities that foster resilience, organizations and nations have unwittingly left themselves exposed to shocks and disruptions. Americans face a multitude of interconnected crises, which will profoundly impact life expectancy, healthy development and aging, social stability, individual and collective well-being, and our very ability to respond resiliently to global threats. Prioritizing economic growth has led to neglect and destabilization of other vital systems critical to human flourishing.

Shifting Paradigms: Building the Nation’s Mental Wealth 

The system of national accounts that underpins the calculation of GDP is a significant human achievement, providing a global standard for measuring economic activity. It has evolved over time to encompass a wider range of activities based on what is considered productive to an economy. As recently as 1993, finance was deemed “explicitly productive” and included in GDP. More recently, Biden-Harris Administration leaders have advanced guidance for accounting for ecosystem services in benefit-cost analyses for regulatory decision-making and a roadmap for natural capital inclusion in the nation’s economic accounting services. This shows the potential to expand what counts as beneficial to the American economy—and what should be measured as a part of economic growth.

While many alternative indices and indicators of well-being and national prosperity have been proposed, such as the genuine progress indicator, the vast majority of policy decisions and priorities remain focused on growing GDP. Further, these metrics often fail to recognize the inherent value of the system of national accounts that GDP is based on. To account for this, Mental Wealth is a measure that expands the inputs of GDP to include well-being indicators. In addition to economic production metrics, Mental Wealth includes both unpaid activities that contribute to the social fabric of nations and social investments that build community resilience. These unpaid activities (Figure 1, social contributions, C_s) include volunteering, caregiving, civic participation, environmental restoration, and stewardship, and are collectively called social production. Mental Wealth also includes the sum of investment in community infrastructure that enables engagement in socially productive activities (Figure 1, social investment, I_s). This more holistic indicator of national prosperity provides an opportunity to shift policy priorities towards greater balance between the economy and broader societal goals and is a measure of the strength of a Well-Being Economy. 

Figure 1.

Mental wealth is a more comprehensive measure of national prosperity that monetizes the value generated by a nation’s economic and social productivity.

Valuing social production also promotes a more inclusive narrative of a contributing life, and it helps to rebalance societal focus from individual self-interest to collective responsibilities. A recent report suggests that, in 2021, Americans contributed more than $2.293 trillion in social production, equating to 9.8% of GDP that year. Yet social production is significantly underestimated due to data gaps. More data collection is needed to analyze the extent and trends of social production, estimate the nation’s Mental Wealth, and assess the impact of policies on the balance between social and economic production.

Unlocking Policy Insights through Systems Modeling and Simulation

Systems modeling plays a vital role in the transition to a Well-Being Economy by providing an understanding of the complex interdependencies between economic, social, environmental, and health systems, and guiding policy actions. Systems modeling brings together expertise in mathematics, biostatistics, social science, psychology, economics, and more, with disparate datasets and best available evidence across multiple disciplines, to better understand which policies across which sectors will deliver the greatest benefits to the economy and society in balance. Simulation allows policymakers to anticipate the impacts of different policies, identify strategic leverage points, assess trade-offs and synergies, and make more informed decisions in pursuit of a Well-Being Economy. Forecasting and future projections are a long-standing staple activity of infectious disease epidemiologists, business and economic strategists, and government agencies such as the National Oceanic and Atmospheric Administration, geared towards preparing the nation for the economic realities of climate change.

Plan of Action 

An American Mental Wealth Observatory to Support Transition to a Well-Being Economy

Given the social deterioration that is threatening America’s resilience, stability, and sustainable economic prosperity, the federal government must systemically redress the imbalance by establishing a framework that privileges an inclusive, holistic, and balanced approach to development. The government should invest in an American Mental Wealth Observatory (Table 1) as critical infrastructure to guide this transition. The Observatory will report regularly on the strength of the Well-Being Economy as a part of economic reporting (see Table 1, Stream 1); generate the transdisciplinary science needed to inform systemic reforms and coordinated policies that optimize economic, environmental, health and social sectors in balance such as adding Mental Wealth to the system of national accounts (Streams 2–4); and engage in the communication and diplomacy needed to achieve national and international cooperation in transitioning to a Well-Being Economy (Streams 5–6).

This transformative endeavor demands the combined instruments of science, policy, politics, public resolve, social legislation, and international cooperation. It recognizes the interconnectedness of systems and the importance of a systemic and balanced approach to social and economic development in order to build equitable long-term resilience, a current federal interagency priority. The Observatory will make better use of available data from across multiple sectors to provide evidence-based analysis, guidance, and advice. The Observatory will bring together leading scientists (across disciplines of economics, social science, implementation science, psychology, mathematics, biostatistics, business, and complex systems science), policy experts, and industry partners through public-private partnerships to rapidly develop tools, technologies, and insights to inform policy and planning at national, state, and local levels. Importantly, the Observatory will also build coalitions between key cross-sectoral stakeholders and seek mandates for change at national and international levels. 

The American Mental Wealth Observatory should be chartered by the National Science and Technology Council, building off the work of the White House Report on Mental Health Research Priorities. Federal partners should include, at a minimum, the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health (OASH), specifically the Office of the Surgeon General (OSG) and Office of Disease Prevention and Health Promotion (ODPHP); the Substance Abuse and Mental Health Services Administration (SAMHSA); the Office of Management and Budget; the Council of Economic Advisors (CEA); and the Department of Commerce (DOC), alongside strong research capacity provided by the National Science Foundation (NSF) and the National Institutes of Health (NIH).

Operationalizing the American Mental Wealth Observatory will require an annual investment of $12 million from diverse sources, including government appropriations, private foundations, and philanthropy. This funding would be used to implement a comprehensive range of priority initiatives spanning the six streams of activity (Table 2) coordinated by the American Mental Wealth Observatory leadership. Acknowledging the critical role of brain capital in upholding America’s prosperity and security, this investment offers considerable returns for the American people.

Conclusion

America stands at a pivotal moment, facing the aftermath of a pandemic, a pressing crisis in youth mental and substance use disorders, and a growing sense of disconnection and loneliness. The fragility of our health, social, environmental, and political systems has come into sharp focus, and global threats of climate change and generative AI loom large. There is a growing sense that the current path is unsustainable. 

After six decades of optimizing the economic system for growth in GDP, Americans are reaching a tipping point where losses due to systemic fragility, disruption, instability, and civil unrest will outweigh the benefits. The United States government and private sector leaders must forge a new path. The models and approaches that guided us through the 20th century are ill-equipped to guide us through the challenges and threats of the 21st century.

This realization presents an extraordinary opportunity to transition to a Well-Being Economy and rebuild the Mental Wealth of the nations. An American Mental Wealth Observatory will provide the data and science capacity to help shape a new generation grounded in enlightened global citizenship, civic-mindedness, and human understanding and equipped with the cognitive, emotional, and social resources to address global challenges with unity, creativity, and resilience.

The University of Sydney’s Mental Wealth Initiative thanks the following organizations for their support in drafting this memo: FAS, OECD, Rice University’s Baker Institute for Public Policy, Boston University School of Public Health, the Brain Capital Alliance, and CSART.

Summary

Maternal mortality is a crisis in the United States. Yet more than 60% of maternal deaths are preventable—with the right evidence-based interventions. Data is a powerful tool for uncovering best care practices. While healthcare data, including maternal health data, has been generated at a massive scale by the widespread adoption and use of Electronic Health Records (EHR), much of this data remains unstandardized and unanalyzed. Further, while many federal datasets related to maternal health are openly available through initiatives set forth in the Open Government National Action Plan, there is no central coordinating body charged with analyzing this breadth of data. Advancing data harmonization, research, and analysis are foundational elements of the Biden Administration’s Blueprint for Addressing the Maternal Health Crisis. As a data-driven technology, artificial intelligence (AI) has great potential to support maternal health research efforts. Examples of promising applications of AI include using electronic health data to predict whether expectant mothers are at risk of difficulty during delivery. However, further research is needed to understand how to effectively implement this technology in a way that promotes transparency, safety, and equity. The Biden-Harris Administration should establish an AI Center of Excellence to bring together data sources and then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles.  

Challenge and Opportunity

Maternal deaths currently average around 700 per year, and severe maternal morbidity-related conditions impact upward of 60,000 women annually. Stark maternal health disparities persist in the United States, and pregnancy outcomes are subject to substantial racial/ethnic disparities, including maternal morbidity and mortality. According to the Centers for Disease Control and Prevention (CDC), “Black women are three times more likely to die from a pregnancy-related cause than White women.” Research is ongoing to specifically identify the root causes, which include socioeconomic factors such as insurance status, access to healthcare services, and risks associated with social determinants of health. For example, maternity care deserts exist in counties throughout the country where maternal health services are substantially limited or not available, impacting an estimated 2.2 million women of child-bearing age.

Many federal, public, and private datasets exist to understand the conditions that impact pregnant people, the quality of the care they receive, and ultimate care outcomes. For example, the CDC collects abundant data on maternal health, including the Pregnancy Mortality Surveillance System (PMSS) and the National Vital Statistics System (NVSS). Many of these datasets, however, have yet to be analyzed at scale or linked to other federal or privately held data sources in a comprehensive way. More broadly, an estimated 30% of the data generated globally is produced by the healthcare industry. AI is uniquely designed for data management, including cataloging, classification, and data integration. AI will play a pivotal role in the federal government’s ability to process an unprecedented volume of data to generate evidence-based recommendations to improve maternal health outcomes. 

Applications of AI have rapidly proliferated throughout the healthcare sector due to their potential to reduce healthcare expenditures and improve patient outcomes (Figure 1). Several applications of this technology exist across the maternal health continuum and are shown in the figure below. For example, evidence suggests that AI can help clinicians identify more than 70% of at-risk moms during the first trimester by analyzing patient data and identifying patterns associated with poor health outcomes. Based on its findings, AI can provide recommendations for which patients will most likely be at-risk for pregnancy challenges before they occur. Research has also demonstrated the use of AI in fetal health monitoring. 

Figure 1: Areas Where Artificial Intelligence and Machine Learning Is Used for Women’s Reproductive Health

Source: Davidson and Boland (2021). 

Yet for all of AI’s potential, there is a significant dearth of consumer and medical provider understanding of how these algorithms work. Policy analysts argue that “algorithmic discrimination” and feedback loops in algorithms—which may exacerbate algorithmic bias—are potential risks of using AI in healthcare outside of the confines of an ethical framework. In response, certain federal entities such as the Department of Defense, the Office of the Director of National Intelligence, the National Institute for Standards and Technology, and the U.S. Department of Health and Human Services have published and adopted guidelines for implementing data privacy practices and building public trust of AI. Further, past Day One authors have proposed the establishment of testbeds for government-procured AI models to provide services to U.S. citizens. This is critical for enhancing the safety and reliability of AI systems while reducing the risk of perpetuating existing structural inequities. 

It is vital to demonstrate safe, trustworthy uses of AI and measure the efficacy of these best practices through applications of AI to real-world societal challenges. For example, potential use cases of AI for maternal health include a social determinants of health [SDoH] extractor, which combines AI with clinical notes to more effectively identify SDoH information and analyze its potential role in health inequities. A center dedicated to ethically developing AI for maternal health would allow for the development of evidence-based guidelines for broader AI implementation across healthcare systems throughout the country. Lessons learned from this effort will contribute to the knowledge base around ethical AI and enable development of AI solutions for health disparities more broadly. 

Plan of Action

To meet the calls for advancing data collection, standardization, transparency, research, and analysis to address the maternal health crisis, the Biden-Harris Administration should establish an AI Center of Excellence for maternal health. The AI Center of Excellence for Maternal Health will bring together data sources, then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles. The Center should be created within the Department of Health and Human Services (HHS) and work closely with relevant offices throughout HHS and beyond, including the HHS Office of the Chief Artificial Intelligence Officer (OCAIO), the National Institutes of Health (NIH) IMPROVE initiative, the CDC, the Veterans Health Administration (VHA), and the National Institute for Standards and Technology (NIST). The Center should offer competitive salaries to recruit the best and brightest talent in AI, human-centered design, biostatistics, and human-computer interaction.

The first priority should be to work with all agencies tasked by the White House Blueprint for Addressing the Maternal Health Crisis to collect and evaluate data. This includes privately held EHR data that is made available through the Qualified Health Information Network (QHIN) and federal data from the CDC, Centers for Medicare and Medicaid (CMS), Office of Personnel Management (OPM), Healthcare Resources and Services Agency (HRSA), NIH, United States Department of Agriculture (USDA), Housing and Urban Development (HUD), the Veterans Health Administration, and Environmental Protection Agency (EPA), all of which contain datasets relevant to maternal health at different stages of the reproductive health journey from Figure 1. The Center should serve as a data clearing and cleaning shop, preparing these datasets using best practices for data management, preparation, and labeling.

The second priority should be to evaluate existing datasets to establish high-priority, high-impact applications of AI-enabled research for improving clinical care guidelines and tools for maternal healthcare providers. These AI demonstrations should be aligned with the White House’s Action Plan and be focused on implementing best practices for AI development, such as the AI Risk Management Framework developed by NIST. The following examples demonstrate how AI might help address maternal health disparities, based on priority areas informed by clinicians in the field:   

1. AI implementation should be explored for analysis of electronic health records from the VHA and QHIN to predict patients who have a higher risk of pregnancy and/or delivery complications. 
2. Drawing on the robust data collection and patient surveillance capabilities of the VHA and HRSA, AI should be explored for the deployment of digital tools to help monitor patients during pregnancy to ensure adequate and consistent use of prenatal care.  
3. Using VHA data and QHIN data, AI should be explored in supporting patient monitoring in instances of patient referrals and/or transfers to hospitals that are appropriately equipped to serve high-risk patients, following guidelines provided by the American College of Obstetricians and Gynecologists.
4. Data on housing from HUD, rural development from the USDA, environmental health from the EPA, and social determinants of health research from the CDC should be connected to risk factors for maternal mortality in the academic literature to create an AI-powered risk algorithm.
5. Understand the power of payment models operated by CMS and OPM for novel strategies to enhance maternal health outcomes and reduce maternal deaths.

The final priority should be direct translation of the findings from AI to federal policymaking around reducing maternal health disparities as well as ethical development of AI tools. Research findings for both aspects of this interdisciplinary initiative should be framed using Living Evidence models that help ensure that research-derived evidence and guidance remain current.

The Center should be able to meet the following objectives within the first year after creation to further the case for future federal funding and creation of more AI Centers of Excellence for healthcare:

1. Conduct a study on the use cases uncovered for AI to help address maternal health disparities explored through the various demonstration projects.
2. Publish a report of study findings, which should be submitted to Congress with recommendations to help inform funding priorities for subsequent research activities.
3. Make study findings available to the public to help build public trust in AI.

Successful piloting of the Center could be made possible by passage of an equivalent bill to S.893 in the current Congress. This is a critical first step in supporting this work. In March 2021, the S.893—Tech to Save Moms Act was introduced in the Senate to fund research conducted by National Academies of Sciences, Engineering, and Medicine to understand the role of AI in maternal care delivery and its impact on bias in maternal health. Passage of an equivalent bill into law would enable the National Academies of Sciences, Engineering, and Medicine to conduct research in parallel with HHS to generate more findings and to broaden potential impact.

Conclusion

The United States has the highest rate of maternal health disparities among all developed countries. Yet more than 60% of pregnancy-related deaths are preventable, highlighting a critical opportunity to uncover the factors impeding more equitable health outcomes for the nation as a whole. Legislative support for research to understand AI’s role in addressing maternal health disparities will affirm the nation’s commitment to ensuring that we are prepared to thrive in a 21^st century influenced and shaped by next-generation technologies such as artificial intelligence.

This month marks three years since the COVID pandemic took hold of nearly every aspect of American life. In a few more months (May 2023) the coronavirus public health emergency is set to conclude officially, following the Administration’s announcement to wind down the declarations. As the nation grapples with the tragedies and lasting effects of the pandemic, it should also take lessons from the most successful elements of how the government responded to the challenge. The most notable success might be Operation Warp Speed (OWS), the highly successful public-private partnership that produced and distributed millions of live-saving vaccines in record time. Our new memo, How to Replicate the Success of Operation Warp Speed, helps this audience assess how and if they even should attempt to replicate the approach.

The Federation of American Scientists, together with our partners at 1Day Sooner and the Institute for Progress (IFP), convened leadership from the original OWS team, agency heads, Congressional staffers, researchers, and representatives from vaccine manufacturers in November 2022 to reflect on the success of the program and future applications of the model. The memo was developed primarily from notes on presentations, panel discussions, and lively breakout conversations that were both reflective and forward looking. This piece complements other analyses by providing a practical, playbook-style approach. Those looking to replicate the success of OWS should consider the stakeholder landscape and the state of fundamental science before designing a portfolio of policy interventions. 

Assess the stakeholder landscape and science surrounding the challenge

A program on the exact scale of OWS will only work for major national challenges that are self-evidently important and urgent. Designers should assess the stakeholder landscape and consider the political, regulatory, and behavioral contexts. The fundamental research must exist, and the goal should require advancing it for a specific use case at scale. Technology readiness levels (TRLs) can help guide technology assessment—a level of at least 5 is a good bet. All decisions about technology readiness should be made using the best available science, data, and demonstrated capabilities.

Design an agile program by selecting a portfolio of interventions

Choose a selection of the mechanisms below informed by the stakeholder and technology assessment. The organization of R&D, manufacturing, and deployment should be inspired by agile methodology, in which planning is iterative and more risk than normal is accepted. 

1. Establish a leadership team across federal agencies
2. Coordinate federal agencies and the private sector
3. Activate latent private-sector capacities for labor and manufacturing
4. Shape markets with demand-pull mechanisms
5. Reduce risk with diversity and redundancy

Operation Warp Speed was a historic accomplishment on the level of the Manhattan Project and the Apollo program, but the unique approach is not appropriate for everything. Read the full memo to understand the mechanisms and the types of challenges best suited for this approach. Even if a challenge does not meet the criteria for the full OWS treatment, the five mechanisms can be applied individually to better coordinate agencies and the private sector toward solutions.

As the COVID-19 pandemic has clearly shown – American health is crucial to the health of our nation. Yet American health is under threat from all angles, from escalating chronic deadly diseases like cancer to rising mental health challenges and the growing overdose epidemic. All of these threats contribute to the United States ranking 31st in life expectancy at birth, one of the lowest in the developed world, despite having the highest health spending per capita.

At the State of the Union, the Biden Administration presented a bipartisan platform dedicated to securing the health and wellbeing of the American people, from our Veterans to our youth. An agenda is a first step – unified action on public health comes next. Evidence-based science policy can bring us closer to a healthier future. Since 2020, policy entrepreneurs have developed innovative implementation-ready policy proposals through the Day One Project (D1P) to tackle some of the biggest societal problems. Here are a few that speak to the current moment:

To combat cancer…

With the median monthly cost of cancer drugs topping $10,000, many families cannot afford the costs of caring for their loved ones. Yet, there are 1,100 FDA-approved off-patent generics that could be used for treating cancer, at a fraction of the cost. Congress should appropriate $100 million into Phase III clinical trials of off-patent generics for treating a variety of cancers. This funding can go towards the National Cancer Institute and be implemented through an open-source pharmaceutical R&D framework through accelerated progress towards accessible and affordable cures.

Environmental hazards are a growing driver of cancers, and disproportionately impact rural and disadvantaged communities. Air pollution has been linked to lung cancer, the most deadly cancer for both men and women in the US. An interagency collaboration led by National Oceanic and Atmospheric Administration and leveraging funds from the Inflation Reduction Act could deploy a network on low-cost, real-time, ground-based sensors in all 300 US cities with a population above 100,000 to track particulate matter rates. Connecting this data to relevant providers in these cities, such as federally-qualified community health centers, could inform physicians of high-risk sites to target early screening interventions. Further, materials composing American homes, from housing materials to pipe materials, and even water running in the faucets, have been identified as possible sources of carcinogens. The Biden Administration should launch the President’s Task Force on Healthy Housing and Water for Cancer Prevention to coordinate research, develop the statistical database, and prepare for regulatory actions.

Finally, innovations in primary care can also catch cancer at earlier stages in disease progression. Yet, many rural and disadvantaged communities lack access to primary care. The NIH’s $23 million investment investigating telehealth for cancer care will develop the best care strategies – but labor-market, technical, financial/regulatory barriers, and data barriers will remain for scaling to the broad population. The Biden Administration and Congress will need to collaborate to unlock barriers to delivering healthcare services directly to the American home, through reforming licensure, expanding broadband access, investing in new mobile healthcare devices, expanding Medicare and Medicaid reimbursements, and ensuring data interoperability.

To strengthen mental health…

Digital mental health technologies have enormous potential to combat the growing mental health crisis, as evidenced by the Administration’s plan on mental health research and development. Yet more work remains to build a national infrastructure for successful implementation of digital mental health services. The vast majority of digital mental health technologies are unregulated, as existing FDA standards fail to cover these emerging technologies because many do not make treatment claims. Congress should authorize Health and Human Services (HHS) to develop standards for digital mental health products to ensure clinical effectiveness, data safety, and mitigate risk. Technologies that meet these standards should then be reimbursable through Medicare and Medicaid, which will require further congressional action. Finally, the Substance Abuse and Mental Health Services Administration (SAMHSA) should create a National Center for Digital Mental Health to maintain a database of approved digital products, provide training to providers, and ensure compliance of developers with national standards.

Knowing that tech platforms can be harmful to the youth’s wellbeing, the Congress and the Administration can take several steps to protect children’s privacy. Congress can expand the technological expertise at the Department of Education (ED) to protect children’s privacy and security in schools as well as appropriate $160 million funding to the Federal Trade Commission (FTC) to expand Children’s Online Protection Privacy Act (COPPA) enforcement and further investigate technology companies extracting children’s data. The Administration can commission a task force to identify ways to protect children’s data through existing legislation such as the Family Educational Rights and Privacy Act and COPPA.

To tackle the opioid crisis…

The opioid crisis is claiming thousands of lives every year, and there is bipartisan consensus on action. The Centers for Medicare and Medicaid (CMS) has sought strategies to prevent opioid use disorders – which will require reforms to the insurance reimbursement model which less generously covers preventative services. The Biden Administration should pilot a multidisciplinary study group to implement payment for prevention, using opioid use disorders as the test case. Following the guidance of the study group, CMS should provide guidelines to contracts between states and managed care organizations (MCOs) and between MCOs and providers and provide necessary technical assistance to implement these guidelines.

To deliver on care for Veterans…

Five million veterans live in rural areas, and of those, 45% lack access to reliable broadband internet, reducing access to vital health services. To ensure Veterans remain connected to healthcare services wherever they are, the Veterans Health Administration (VHA) should partner with the Postal Service and/or Department of Agriculture to pilot telehealth hubs in rural communities using existing FY23 appropriations for telehealth. An initial focus of care delivery could be on digital mental health and suicide prevention. Going forward, care delivery innovations like this one, if successful, can inspire new policies for the broader population, if the VHA’s health policy mission is expanded. VHA should be added to strategic interagency health policy coalitions such as the ACA interagency working group on healthcare quality and Healthy People 2030 to share data, develop innovative projects, and evaluate progress.

There’s more work to be done to build a healthier future for all Americans – these ideas can be jumping off points for Executive and Congressional action. FAS will continue to develop and surface evidence-based policies that can make a difference, and submissions to the Day One project are always welcome.

For the United States, the economic, societal, and national security benefits of the life sciences are vast. The U.S. bioeconomy – the part of the economy driven by the life sciences and biotech, and enabled by engineering, computing, and information science – is valued at over $950 billion. Life sciences research leads to cleaner crops through pollution-free fertilizers, and access to life-saving vaccines, like those mRNA vaccines that helped counter the devastating impacts of COVID-19. And industries built on the life sciences create good-paying jobs across the country.

The 118th Congress can adopt policy to help drive U.S. biotech and biomanufacturing to grow regional prosperity, deliver on conservation goals, and improve U.S. competitiveness and resilience. Here are some ideas.

Advancing the U.S. Bioeconomy to Create Jobs and Bolster Competitiveness. Many provisions in the bipartisan CHIPS and Science Act are intended to enable the bioeconomy. Implementation should focus on three areas: cutting-edge R&D, fundamental and publicly available tools, and biomanufacturing. To further support fundamental research, Congress could direct the National Institutes of Health (NIH) to aim to maximize returns on its massive R&D budget by piloting novel funding mechanisms with evaluation through randomized control trials, funding more high-risk high-reward research, and dedicating more funding to early-career researchers. Congress could also establish a Plant Genome Research Institute (PGRI) that would drive plant genomics research and centralize federal government activities, helping to promote crop innovation and enable a diversified, localized, and resilient food system. And to ensure all Americans benefit fully, actions should be taken to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases.

To promote U.S. bioindustrial manufacturing scale-up and commercialization, Congress could authorize a Bio for America Program Office at the National Institute of Standards and Technology. With appropriations, the office would house a suite of initiatives:

• A Bioindustrial Production Consortium that coordinates precompetitive efforts helping to address the measurements, tools, and standards needed for advancing both research and commercial products in the bioindustrial production space, and that collaborates with BioMADE, industry, government scientists, and other stakeholders.
  
• BAPO Ventures, which would seed a nonprofit partnership manager to launch a U.S. Bioindustrial Production Investment Portfolio to crowd-in additional capital from non-federal government sources and makes calculated investments in early-stage, domestic bioindustrial production companies that demonstrate credible pathways to product commercialization.
  
• The Bioindustrial Production Scale-up Infrastructure Group, which as an initial step would work with both the interagency and non-federal government partners to conduct a comprehensive analysis of the U.S. bioindustrial production pilot- and intermediate-scale infrastructure landscape in order to develop a precision strategy for moving forward on domestic bioindustrial production scale-up capacity.
  
• A Bioindustrial Production Loan Program Office that relies on partners such as the U.S. Small Business Administration to help it provide debt financing for techno-economically sound, domestic demonstration- or commercial-scale bioindustrial production infrastructure projects.

Importantly, Congress can help prepare and invite more Americans into skilled jobs that support the bioeconomy, building a better future for Americans in all 50 states – including people of color, people with disabilities, and people from economically disadvantaged backgrounds – by funding modernized biology education, establishing world-class entrepreneurial hubs for biotechnology in non-traditional regions of the country, and supporting equitable access to industry-recognized certificates and work-based training.

Biotech can also be leveraged to fast-track our nation’s capability to deliver on conservation goals, remediate contaminated habitats, and detect dangerous environmental toxins and pathogens. To that end, Congress could establish a national center to achieve several important goals:

• Provide competitive grant funding across three key tracks – carbon capture, bioremediation, biomonitoring – to catalyze comprehensive environmental biotechnology research
• House a bioethics council to develop and update guidelines for safe, equitable environmental biotechnology use
• Manage testbeds to efficiently prototype environmental biotechnology solutions; and
• Facilitate public-private partnerships to help transition solutions from prototype to commercial scale.

Safeguarding Americans Against Biological Threats. The human and economic toll of COVID-19 has shown the need to be better prepared for future pandemics and epidemics. And yet, there is currently little to no economic incentive for pharmaceutical companies to engage in vaccine research for infectious diseases that have not, and yet could, cause a pandemic. To address this market failure, the U.S. should incentivize vaccine development for priority emerging infectious diseases through federal financing. Specifically, Congress should authorize and appropriate $10 billion to the Biomedical Advanced Research and Development Authority (BARDA) over 10 years to create an investment fund that would:

• Leverage demand-pull mechanisms to purchase vaccines in bulk during future outbreaks and promote innovation in vaccine R&D
• Support manufacturing and distribution facilities
• Provide limited government guarantees, equities, and securities to investors in vaccine development.

Masks, especially high quality respirators, are disease-agnostic tools that can help reduce infections from respiratory diseases like the flu virus and RSV. In turn, this can reduce the burden on doctors and hospitals, and avoid additional healthcare. To that end, the mail delivery system used to distribute COVID-19 diagnostic tests should be augmented by the addition of a masks via mail program. The COVID-19 test mailing program should be restarted and expanded to include an option for ordering one box of 10 free N95 masks every quarter, for those Americans who wish to participate. Additionally, rotating face-mask inventory from the Strategic National Stockpile in a “first in, first out” method will prevent masks from being stored past their recommended shelf life, and promote continual replenishment of the U.S.’s stockpile. The recent National Strategy for a Resilient Public Health Supply Chain, as well as the bipartisan PPE in America Act (H.R.1436) and the bipartisan PREVENT Pandemics Act (S.3799), all advocate for a rotating stock system; however, steps must be taken to better operationalize its implementation and instate a timeline. Congress should authorize the Administration for Strategic Preparedness and Response to grant the HHS Coordination Operations and Response Element key management and distribution responsibilities for critical diagnostic and preventative measures like tests and masks.

The impact of the COVID-19 pandemic was significantly worsened by the presence of diseases that persist at relatively stable case numbers within a particular region. Additional infections paired with COVID-19 infections can lead to lower survival rates and longer hospital stays, creating a drain on resources as well as higher morbidity and mortality effects. Congress should thus authorize an initiative within the Centers for Disease Control and Prevention that enhances the reporting and tracking of regional diseases and helps reduce the data gap that prevents actions and responses to countering circulating diseases. The initiative could be incorporated into S. 3814, the bipartisan Modernizing Biosurveillance Capabilities and Epidemic Forecasting Act.

Finally, the bipartisan Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) will expire in 2023. This law contains several integral provisions for national health security, public health preparedness, biosurveillance, and emergency medical countermeasures, as well as authorizations for BARDA and the Assistant Secretary for Preparedness and Response (ASPR). Congress should re-authorize PAHPAIA, as it forms the bedrock of America’s pandemic preparedness architecture, and consider expanding its purview to address aspects of other U.S. challenges such as wildfires and antimicrobial resistance.

Appropriations Recommendations

Bioeconomy in CHIPS and Science. There are many provisions critical to the U.S. bioeconomy in the CHIPS and Science Law, which Congress should ensure receive robust appropriations. These include:

• Coordinating and strategy activities in Title IV, focused on Bioeconomy Research and Development;
• Title III, Subtitle G, National Science Foundation Directorate for Technology, Innovation, and Partnerships. The directorate is authorized at $3.4 billion overall in FY 2024. The list of critical technologies the new directorate is intended to advance (Section 10387) includes biotechnology, medical technology, genomics, and synthetic biology, all relevant to the bioeconomy. The directorate also funds the Regional Innovation Engines program promoting biotech partnerships and commercialization efforts across the U.S. in biotech.
• Title II, Section 10221, which directs the National Institute of Standards and Technology to conduct an array of activities in engineering biology and biometrology.
• Title I, Section 10103, Department of Energy (DOE) Biological and Environmental Research (authorized at $947 million in FY 2024), which funds an array of fundamental research in the biosciences.
• Title I, Section 10112, Office of Science Emerging Biological Threat Preparedness Research Initiative (authorized at $50 million in FY 2024), which establishes a cross-cutting program to leverage DOE analytical resources and tools, user facilities, and advanced computational and networking capabilities to support efforts that prevent, prepare for, predict, and respond to biological threats to national security, including infectious diseases.

Congress should provide robust appropriations to all activities, as close to the CHIPS authorizations as possible, to ensure a dynamic and innovative bioeconomy sector.

Bioproduct Pilot Program. The National Institute of Food and Agriculture’s (NIFA) Bioproduct Pilot Program (created in the Infrastructure Investment and Jobs Act, Sec. 70501) is intended to increase economic activity in rural areas of the U.S. while also lowering commercialization risks associated with bringing biobased products to market. The program aims to study the benefits of using materials derived from covered agricultural commodities for manufacture of construction and consumer products. The program’s work also enables the development of a more circular economy, where finite resources are not just extracted and consumed but also regenerated in a sustainable manner. Adopting a more circular economy ensures that wealth and other economic benefits in the form of jobs and other opportunities are created, and stay in, rural communities, while learnings can be shared throughout the U.S. innovation ecosystem.

A total of up to $5 million is available for the program for each of FY 2022 and FY 2023. The availability of funds for the program should be extended through FY 2028, with yearly increases to a level above $5 million per year according to the requests of NIFA/the program team.

Scaling and Regionalizing Networked Bioindustrial Manufacturing. The 2023 NDAA (Division A, Section 215) directs the Secretary of Defense to establish and expand a network of manufacturing innovation institutes and intermediate scale facilities for R&D, piloting, and scaling of innovative bioindustrial manufacturing processes and products. Support for these activities is critical to ensure the industrial base can leverage bioindustrial manufacturing processes for the production of chemicals, materials, and other products necessary to support national security and secure fragile supply chains. Congress should provide $500 million in appropriations across national security bioeconomy activities including $300 million for biomanufacturing innovation institutes, in accord with the NDAA.

Countering Global Malnutrition to Enhance U.S. Security. Due to the COVID-19 pandemic, environmental impacts, and conflicts like the war in Ukraine, global rates of malnutrition are at eight percent and are forecast to become even worse. Providing life-saving treatment around the world serves a core American value of humanitarianism, and a priority for U.S. national security – the newly released National Security Strategy dedicates an entire section to food insecurity.

In 2021 legislation, Congress directed USAID to advance programs to prevent and treat malnutrition around the world and develop a Global Nutrition Coordination Plan. That legislation also directed USAID to create the Nutrition Leadership Council, which can help elevate nutrition programs across U.S. global health interventions and foster collaboration with other sectors, development agencies, partner governments, and local actors. These are important steps to create a centralized food security program with harmonized funding – a system to deploy a more effective response to end global malnutrition and improve U.S. national security.

Congress should work with the Administration to begin scaling up global malnutrition assistance in FY 2024, in accord with the 2021 legislation.

Supporting the U.S. Emergency Response Workforce. The National Disaster Medical System (NDMS) is an integral part of the United States’ pandemic and hazards preparedness and response infrastructure. NDMS has a unique ability to coordinate and deliver emergency medical services to both federal and state, local, tribal, or territorial (SLTT) agencies. During the COVID-19 pandemic, NDMS deployed all across the country to provide training, medical care, coordinate medical supply delivery, and ensure effective communication. Additional appropriations would go toward hiring more personnel and bolstering in-person activities in the wake of COVID-19. Congress should ensure NDMS is funded up to FY 2024 request levels.

Just over a year ago, I found myself pausing during a research lab meeting. “Why were all the subjects in our studies of wearable devices white? And what were the consequences of exclusion?”

This question stuck with me long after the meeting. Digging into the evidence, I was alarmed to find paper after paper signaling embedded biases in key medical technologies. 

One device stuck out amongst the rest – the pulse oximeter. Because of its crucial role in diagnosing COVID-19, it had caught the attention of a diverse group of stakeholders: clinicians looking to understand the impacts on patient care, engineers working to build more equitable devices, social scientists tracing the history of device and examining colorism in pulse oximetry, policymakers seeking solutions for their constituents, and the FDA, which was examining racial bias in medical technologies for the first time. But what I found as I scoped out this policy area is that these stakeholders weren’t talking to one another, at the expense of coordinated progress towards equity in pulse oximetry. 

With all eyes directed towards the FDA’s Advisory Committee meeting on November 1st, 2022, FAS convened a half-day session of stakeholders on November 2nd to chart a research and policy agenda for near-term mitigation of inequities in pulse oximetry and other medical technologies. Eight experts from medicine, engineering, sociology, and anthropology shared insights with an audience of 60 participants from academia, the private sector, and federal government. Collectively, we developed several key insights for future progress on this issue and outlined a path forward for achieving equity now. You can access the full readout here. We’ll dive into the key highlights below:

Key Insights

Through discussions with experts during the forum, three key themes rose to the surface:

• Racial bias in pulse oximetry cannot be fixed by focusing on “race” alone. Existing evidence suggests reducing bias in pulse oximetry requires replacing devices with less-biased ones. This will take time as new devices are developed and will be a significant cost. 
• Better calibration for skin tone is vital, but measurement is complicated. The crux of the problem is a comprehensive standard for quantifying the full range of skin pigmentation. This is vital to understanding how pulse oximeter accuracy varies by melanin content.
• Proactively identifying and addressing bias in medical devices will require system-wide efforts. Identification of bias in medical devices has been piecemeal rather than the outcome of proactive, deliberative efforts. Further efforts to address bias in medical devices should engage diverse stakeholders to establish best practices for ensuring equity in medical devices.

Resolving the problem of bias in pulse oximeter devices will likely take several years. But in the meantime, this issue will continue negatively impacting patients. Our participants urged that we need to think about actions that can be initiated this next year that will advance more equitable care with existing pulse oximeters. 

In-person stakeholders convening a focused conversation on next steps

Motivating Action for Equity Now

While a daunting problem, a collaborative, multi-stakeholder effort can bring us closer to solutions. We can work together to advance equity in standards of care by:

• Gathering evidence on existing pulse oximeter devices and their use in care [ASAP, start early 2023]. More evidence is required to identify the best approaches to equitable care with existing devices. This evidence gathering process should be initiated over the next year to inform clinicians on 
• Establishing consensus to advance the standard of care [start early 2024]. After growing the body of evidence, there will be a need to convene around key conclusions derived from the evidence. Evidence synthesis will need to be generated and care societies will need to make decisions on how clinicians should use pulse oximeters in their care practice.
• Taking action to ensure equitable care nationwide [2024 onwards]. Once the care standards are changed, there is a need for system-wide efforts to communicate these to clinicians nationwide, inform procurement across federal hospitals, and re-evaluate insurance reimbursement standards.

Mapping out a plan of action towards equity

Looking Ahead

This won’t be easy, but it’s 30 years overdue. We believe correcting the bias will pioneer a model that can be readily applied to combatting biases across the medical device ecosystem, something already underway in the United Kingdom with their Equity in Medical Devices Independent Review. Through a systematic approach, stakeholders can work to close racial disparities in the near-term and advance health equity.