From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA holds one of the most important roles as a federal agency which is to ensure public safety when approving vaccines, medical devices, and medicines. The approval of these products usually require extensive trials with data that supports their safety and efficacy. Considering that most of these decisions are complex and multifaceted, the FDA enlists the support of Advisory Committees to assist with their decision-making process. The primary role of FDA Advisory Committee members is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. Although AdComm members serve the FDA in an advisory capacity, their recommendations are non-binding. Therefore, they do not have the final say in the regulatory approval process. 

However, over the years, it has been made evident that the public is unaware of the role of Advisory Committees and ways in which they can engage with the FDA. In this case study, FAS hopes to share the current problem and actionable recommendations to combat public misconceptions regarding FDA AdComm roles and provide guidance on increasing FDA engagement with the public and other relevant stakeholders throughout the regulatory process.

Public Awareness Problems

While AdComm members are experts in their respective fields and volunteer their time to provide advice to the FDA, there are multiple factors that must be considered before making official decisions. The recommendations provided during Advisory Committee meetings are just one aspect that is considered for regulatory decision-making and do not guarantee an official approval or denial of a product by the FDA. During AdComm meetings, the FDA allows the general public to make public comments to the Agency and the AdComm regarding the topic that is being addressed. Despite this, members of the general public have expressed that, on many occasions, they are unaware AdComm meetings are occurring. This, in effect, deprives them of the opportunity to communicate directly with the FDA and the AdComm. Additionally, they feel the FDA fails to engage them in an adequate manner, thereby limiting opportunities for participatory engagement. It has also been noted that most members of the general public are unaware FDA Advisory Committees exist; and, for those who are aware, they are unclear about the capacity of their role within the regulatory process. 

For these reasons, the FDA must take measures to enhance public understanding in an effort to combat misinformation, educate, and raise awareness on the existence of Committees and their purpose.  

Communicating AdComms to the Public

Improving Public Awareness of Advisory Committees and their Role

Improving public awareness on the existence of FDA Advisory Committees and their purpose would assist the FDA with improving public trust and debunking myths and misinformation related to the approval of medical products. Advisory committees operate as an independent party and their recommendations assist with guiding regulatory decision-making. However, their recommendations are non-binding, and FDA leadership must consider additional factors before granting approvals or denials of medical products. 

To increase public awareness on Advisory Committees, it should be made clear that AdComm recommendations are not conclusive, as the FDA considers multiple factors in its official decisions. The FDA can leverage social media platforms to increase awareness and understanding of AdComms through the use of disseminating information via the use of ads and active social media engagement. A survey conducted by Pew Research Center states that eight in ten Americans believe social media platforms are an effective way to bring awareness. In addition, disclaimers should be included on all public facing materials referencing AdComms to indicate their purpose. Clearly communicating this to the public will dispel myths that AdComms make the final call on the approvals of medical products. 

Improving Communication about Advisory Committee Meetings

Encouraging public participation for Advisory Committee meetings will help foster a collaborative and engaged general public who can contribute valuable life experience to the regulatory process. FAS has identified ways in which the FDA can better communicate with the public to inform them of Advisory Committee meetings. First, the FDA can develop a webpage that allows people to receive notifications of upcoming AdComm meetings. The FDA can also establish relationships with state and local public health agencies, as well as advocacy organizations to spread awareness. Through these relationships, the various agencies and organizations can use their networks to disseminate widespread information on AdComm meetings. Public health agencies and advocacy organizations can gauge the best ways in which these communities would like the FDA to engage with them. This understanding of the communities they serve makes them an ideal partner for fostering continuous engagement.  

Policy Recommendations

In an effort to improve public awareness and understanding of AdComms, the potential policy recommendations are as follows: 

• FDA can leverage social media platforms to increase awareness and understanding of AdComms through the use of disseminating information (e.g., engagement, ads, etc.)
• FDA should include a disclaimer on all communications and marketing materials regarding AdComms
  • These disclaimers should be made at all public meetings
  • Disclaimers should emphasize the purpose of AdComm votes. Disclaimers should state that votes allow AdComm members to provide an official stance to the FDA as experts, but votes are non-binding.
• Develop a webpage that allows people to be placed on a listserv regarding upcoming meetings
• Partner with state and local public health agencies and advocacy organizations to spread awareness

Conclusion

Advisory Committees are essential to the FDA regulatory decision-making process. It’s imperative that their role is understood by them and the general public to best move the needle forward. While the FDA currently allows the public to provide public comment at Committee meetings, that alone cannot be considered engaging the community. The FDA must create new opportunities for interpersonal communication which will create an environment of mutual trust and understanding between both parties.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The regulation of medical products is the responsibility of the Food and Drug Administration (FDA). To ensure effective decision-making regarding these products, the FDA recognizes the importance of patient advocacy and the perspectives of patients. In 1988, the FDA initiated the patient engagement process through the Office of Aids Coordination, and within five years, the first patient representative was appointed to an FDA Advisory Committee. Since then, the FDA has significantly enhanced its methods of engaging patients, caregivers, and patient advocates. This includes the establishment of various offices, programs, collaboratives, listening sessions, public guidance, and more.

The Evolution of Patient Engagement at the FDA

The FDA employs several avenues to engage patients in the regulatory process. Some avenues include the Patient Engagement Advisory Committee (PEAC), public comment, the Patient Focused Drug Development Initiative (PFDD), the Patient Listening Session Program, Patient Engagement Collaborative (PEC), and the Patient Representative Program (PRP). This list does not cover all the ways in which the FDA engages patients and advocates but provides an overview of the key operations involved in patient engagement efforts. 

The Patient Engagement Advisory Committee is the only Committee that is completely composed of caregivers, patients, and patient representatives from various organizations, as a way to ensure that the lived experiences of these populations and their opinions are included in the deliberations and regulatory decision-making of medical products. Public comment is a requirement by law for federal agencies, allowing the public to provide feedback on proposed actions or new rules and regulations. Public comment is also sought during Advisory Committee meetings to gather information and perspectives from the public. PFDD meetings provide a platform for the FDA to obtain insights from patients on specific diseases and their treatments. To identify the issues most important to patients, the FDA has a series of guidance documents that are used specifically for PFDD meetings. 

The Patient Listening Session Program facilitates informal meetings between patients, their representatives, and FDA staff. These sessions cover a range of topics, including treatment preferences, quality of life, unmet medical needs, and the impact of diseases and their symptoms. The PEC offers a forum for patients, caregivers, and advocates to discuss patient engagement operations. Lastly, the PRP allows patients, caregivers, and advocates who serve as special government employees the opportunity to provide advice to the FDA’s Commissioner or a designated representative on matters related to medical devices and their regulation.

Although there are various avenues for patient engagement and advocacy participation in the medical product regulation process, there are also ways in which these avenues can be expanded or improved.   

Patient Advocacy Problems

For many years, patients and their caregivers have not seen significant or sustainable treatments that have been developed to treat many illnesses and diseases. Some treatments have proven to be ineffective yet still made it to market approval. On the other hand, there are treatments that met safety and efficacy standards but were not approved. There are also those treatments that are simply not affordable to the populations that need them most. In many of these scenarios, the patient representative voice was lost as they did not have the option to express their concerns or perspectives on certain treatments with decision makers. This further confirms that the role of patient advocacy and allowing space for the patient representative voice is crucial to the regulation process of medical products. 

At the moment, the patient voice is not always heard because there are some FDA Advisory Committees that do not have a patient representative.

While the role of patient advocacy is crucial, it is important to note there should be boundaries in which patient perspective is considered for decision-making. Although patients and their advocates seek treatments that better address their needs, this desire can sometimes obscure their judgment concerning long-term treatment effectiveness. Frequently, patients and their supporters present powerful arguments to Advisory Committees and the FDA for approval of particular medical products which can lead to expedited medical product approval in the absence of supportive evidence. 

The endorsement of eteplirsen, which was intended for the treatment of Duchenne muscular dystrophy (DMD), illustrates this point. Despite a 7 to 3 vote by the FDA’s Advisory Committee against approval due to insufficient evidence of its benefits, opposition from the FDA’s Center for Drug Evaluation and Research’s former leader resulted in the drug’s authorization. This sparked substantial internal and public criticism and led Dr. Ellis Unger from the FDA’s Office of Drug Evaluation to challenge the approval decision. Dr. Unger emphasized that “patient-focused drug development is about listening to patient perspectives about what matters to them; it is not about basing drug approvals on anecdotal testimony that is not corroborated by data.”

This approval was perceived by many as having been heavily influenced by patient advocacy and raised concerns about potential long-term implications for patient health. It also signaled a need to further examine both patient education and the appropriate limits of patient involvement in the regulatory process. This could have been mitigated had there been a list of criteria in place to be followed for public comment. 

Incorporating Patient Perspectives

The Food and Drug Administration (FDA) is committed to understanding the balance of benefits and risks acceptable to patients as they relate to medical products. The FDA defines the role of patient representatives that serve on Advisory Committees as “Special Government Employees” who provide direct input to agency staff and share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information. These representatives are selected by the FDA to serve on Advisory Committees using a specific set of criteria including, but not limited to: 

• “Personal experience with the disease either as a patient or primary caregiver”
• “Knowledge about most treatment options and research for their areas of experience they are representing”
• “Impartiality and compliance with Federal ethics requirements (for example, financial interest, such as stock, in companies that may be affected by FDA decisions)”

This criteria ensures the FDA will understand the patient perspective as it relates to various medical products and ensures those selected to serve on Advisory Committees are knowledgeable about the areas in which they are aiming to provide guidance. Currently, there are some FDA Advisory Committees that do not have a patient representative. Further, the patient representatives serving on committees do not always have voting privileges. The absence of consistent voting privileges for some patient representatives on Advisory Committees and not having a standing patient representative on all committees hinders these individuals from providing an official stance on behalf of the community they represent. Additionally, public comment plays a significant role at Advisory Committee meetings by permitting individuals—including patients, caregivers, and advocacy organizations—to highlight concerns and propose solutions that may not have been previously considered by decision-makers. This process also helps the committee and agency gauge patient acceptance or opposition related to medical products, thereby enhancing their ability to make decisions that more accurately reflect public needs. 

When Sarepta was seeking approval of eteplirsen for the treatment of DMD, a patient advocacy organization brought hundreds of patients, caregivers, and other advocates to the Advisory Committee convening so they could make a public comment to the Committee and the agency. Shortly after, the drug received a swift approval. Although it presented much controversy within the agency and the public, it showed how influential patient advocacy can be. Personal lived experiences, compelling stories of debilitating illnesses, and experiences with current treatment have the ability to impact regulatory decision-making. 

The role of patient advocacy continues to be important in the Advisory Committee process and FDA regulatory decision-making process because it is crucial to assisting with decisions that affect the American public. Patient advocacy can be presented in the form of patient representatives that serve on Advisory Committees, those who make public comments during Advisory Committee convenings, and various outreach programs by advocacy organizations. The role of advocacy gives patients and caregivers support, promotes and protects their rights, and allows broader visibility for the issues that are most important to them. All of these avenues for patient perspective are important to understand how treatments perform, the current needs of the patient population, and how to tailor care for these populations by truly understanding their condition, diagnosis, and current management. Therefore, their voice is critical to truly understanding how various medical products will benefit their population, how they will access and afford these products, and how they will fill an unmet medical need.

Policy Recommendations

In an effort to better leverage Advisory Committee membership, the potential policy recommendations are as follows: 

• Dedicate staff to identifying crucial public comments from patient advocates that should be considered for regulatory decision-making
• Include a patient representative on all committees that are reviewing medical products
  • If possible, ensure that patient representatives selected have basic knowledge of the federal regulation process 
• Establish criteria for which all public comments must abide by
  • This can be done by creating a checklist for the public to review and consider before forming their comment and that clearly delineates the mandatory criteria that a medical product must meet to be considered for approval
  • A disclaimer can also be added to state that there is a specific threshold or sample size of a population who must benefit from the medical product
• Promote patient focused medical product development through the use of incorporating patient perspectives into the life cycle of the regulatory process
  • This can be done through hosting patient town hall discussions for areas such as rare diseases and expanding initiatives such as the Patient Focused Drug Development (PFDD) public meetings
  • Make patient engagement ongoing, rather than only allowing patient engagement quarterly or annually as done with most FDA-led programs and initiatives

Conclusion

The landscape of disease burden and associated symptoms is ever-evolving. To ensure the FDA is best prepared for this changing landscape, patient advocacy and amplifying the patient voice should be considered vital to the development and regulation of medical products. Involving those who are the most impacted by these products is essential. The FDA can further promote the patient perspective and advance patient-centered health through incorporating patient representatives on all Committees that are reviewing medical products, making patient engagement an ongoing process, hosting town halls for patients to allow a broader audience the opportunity to voice opinions, and having dedicated staff to sort through public comments from patients.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA relies on its scientific staff and Advisory Committees to provide conclusions from trial and study data, which aid in the process of regulating and approving medical products. However, there are instances when disagreements arise between the agency’s scientists, statisticians, Advisory Committees, and leadership on the accelerated or full approval of medical products. The resolution of these disagreements present a growing concern about FDA leadership overruling the expert opinions of scientific staff and proceeding with official approvals, thus undermining staff expertise, decreasing agency morale, and potentially diminishing public trust.

When Disagreements Between FDA and AdComms Arise 

The Federal Advisory Committee Act governs the FDA’s Advisory Committees and establishes a process in which the FDA can seek expert advice on various issues related to science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. When the FDA has differing opinions on safety and efficacy requirements of medical products, certain products may be referred to an Advisory Committee for further data review by an impartial entity. To aid in this matter, the FDA has developed guidance detailing the process for assembling Advisory Committees. Since the resources required for convening these committees are significant, the FDA ensures there is substantial uncertainty or disagreement regarding the data. Advisory Committees will discuss the evidence and provide feedback with the goal of producing the most optimal evidence-based resolution. This part of the regulatory process is crucial to the agency’s regulatory decision-making as it involves unbiased parties and leads to transparency, upholding public safety, and maintaining public trust. However, there are times that FDA leadership disagrees with the votes of their Committees and proceeds with controversial approvals. One example of this scenario was approval of the drug Aduhelm. Aduhelm, which was marketed as a treatment for Alzheimer’s, received an overwhelmingly negative vote from the Advisory Committee to move forward with its approval for market distribution. Ten of eleven Committee members stated the data did not support adequate efficacy for approval. Nonetheless, the FDA granted accelerated approval, sparking resignations from a third of their Committee and outrage amongst the public. This disregard for expert opinion was viewed as the FDA exhibiting an approval bias, a perspective the public currently maintains of the FDA. 

In 2023, various organizations and coalitions, such as Doctors for America, Jacob’s Institute of Women’s Health, National Center for Health Research, TMJ Association and more publicly expressed concerns regarding the FDA’s leadership and their approach to drug approvals through a letter addressed to the FDA’s Chief Scientist, Dr. Namandje N. Bumpus. They highlighted FDA leadership had ignored claims by scientific staff that safety and efficacy standards were not being met for the drug Elevidys. Manufactured by Sarepta Therapeutics, Elevidys was granted accelerated approval by FDA leadership. Dr. Bumpus responded to this letter defending the FDA’s approval of Elevidys by referring to the agency’s comprehensive review of the data and consideration of the potential risks of the approved treatment, nature of the disease and its impact on patients, and the limited amount of therapies available. However, the response did little to quell public scrutiny of the controversial approval. Critics were apt to point out that the FDA had a record of approving products in this manner. Years prior, the FDA had approved the drug Eteplirsen for the treatment of duchenne muscular dystrophy (DMD), despite the objections of their scientific staff which disclosed a lack of evidence for the efficacy of this treatment. Criticism was also directed at FDA leadership suggesting the approval of some medical products were potentially due to favoritism toward companies seeking approval.

Resolving Internal FDA Disagreements

While it is acknowledged that the FDA must consider technological and political implications alongside scientific evidence in decision-making, it is essential to address the concerns of these organizations and coalitions. As part of an ongoing project to reform the FDA’s Advisory Committee system and assist the FDA with getting the advice needed to make the best evidence-based decisions, FAS engaged in discussions with current and former Advisory Committee members to seek their input on resolving disagreements between FDA staff and leadership. These conversations highlighted the breach of trust between the FDA, its staff, and the public.

The FDA’s Commissioner has acknowledged the lack of trust within the institution and expressed a commitment to address the issue. There are many reasons for the lack of trust. However, one reason stems from the FDA’s approval of medical products despite clear opposition from its scientists and sometimes Advisory Committee members.

This raises the question of how the FDA intends to address these internal disagreements, which have the potential to impact the health and safety of the American public. Currently, the FDA has implemented a program called Scientific Dispute Resolution (SDR) to handle such conflicts. This document was initially developed in 2009 and recently updated in 2021 with the purpose of outlining the process for communication regarding internal scientific disputes within FDA Centers. It defines scientific disputes as disagreements that arise from the interpretation of science and the resulting decisions. This definition clearly distinguishes the circumstances in which the guidance should be utilized to resolve discrepancies between FDA scientists, statisticians, and their respective Center leadership. The guidance offers valuable examples of best practices for resolving formal and informal scientific disputes within the agency. Some of those best practices include, but are not limited to: 

• Centers employing various mechanisms to disseminate dispute resolution Standard Operating Procedures (SOPs) to employees.
• Requiring Center SOPs for dispute resolution to clearly state that written documentation is the only avenue in which a formal dispute can be triggered (this step ensures appropriate historical documentation).
• Developing several avenues to address scientific issues through the use of regulatory briefings, advisory committees, internal discussions with Center Directors, standing subject matter committees, and multi-disciplinary teams. 

However, it should be noted these best practice recommendations are not obligatory and their adoption is left to the discretion of the individual Centers. Furthermore, the document provides a process by which any of the internal parties involved can appeal the resolution of their dispute if they find it unsatisfactory through the Office of Research  Integrity at Health & Human Services (HHS).

Policy Recommendations

To increase morale and improve the approach and resolution of internal disagreements within the agency, the policy recommendations are as follows:

1. Ensure that all FDA staff and leadership are fully cognizant of the existence and details of the Scientific Dispute Resolution at FDA guidance and the process for submitting disputes for review.
2. Incorporate the Scientific Dispute Resolution at FDA guidance into FDA regulations
   1. Note: To incorporate this guidance into FDA regulations, the FDA will propose the regulation for OMB review. OMB will review and open the regulation up for public comment through the Federal Register. Responses to comments will be developed, and a final draft submitted to OMB for review. If approved, the final regulation will be published in the Code of Federal Regulations (Congressional Research Service, 2013). The involvement of Congress will not be necessary.
3. Amend the Scientific Dispute Resolution at FDA guidance to dictate the mandatory execution of best practices within the dispute resolution process.
   1. This guidance should identify additional non-biased parties (that may not be government-affiliated) to provide impartial guidance on complex scientific matters affecting public safety. 
4. Develop guidance that clearly explains a transparent process to communicate effectively with AdComm members regarding decision making when parties have opposing viewpoints
   1. Implementing a transparent process to communicate with AdComm members regarding differences between the agency and the AdComm will assist in improving morale between both parties, but also encourage continued support of the AdComm.
   2. This recommendation is also supported by a survey conducted by 3D Communications with 400+ AdComm members where 94% of members concurred that the FDA should develop a process to communicate their reasoning for decisions in opposition to Committee recommendations (3D Communications, 2024).

Conclusion

While FDA leadership ultimately holds the authority to grant approvals, it is crucial that the perspectives of all experts are duly considered. This includes the valuable input from the agency’s scientists, statisticians, and advisory committees. To regain public trust and restore integrity, it is imperative to first rebuild trust internally among the dedicated public servants within the FDA. Adoption of the aforementioned recommendations would start the trust-rebuilding process and lead to increased safety and precaution measures when approving drugs and medical devices.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA relies on its scientific staff and Advisory Committees to provide conclusions from trial and study data, which aid in the process of regulating and approving medical products. Discussions have been centered around how to appropriately leverage the membership of Advisory Committee experts to assist with areas of difficulty surrounding the safety and efficacy of medical products. Nonetheless, the methods by which these systems currently generate the evidence the Government needs can be improved. This case study focuses on five key areas we believe can assist in fully utilizing the capacity in which AdComms serve and improve overall engagement with AdComms membership.

AdComm Membership Problems

Advisory Committees serve as the core for expert engagement in the Food and Drug Administration’s (FDA) decision-making processes and are composed of medical professionals, industry representatives, patient advocates, and scientific experts. Their primary role is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction.

The intricacies of being an effective AdComm member, however, have been somewhat overlooked. Conversations with current and ex-members have highlighted areas for enhancement that would strengthen the function of AdComms and enrich the advice provided. Feedback indicated a lack of transparency in the FDA’s recruitment methods for committee positions, insufficient orientation or training for new members, limited understanding of regulatory procedures among members, and an onerous conflict of interest protocol that served as a deterrent for some members who were asked to return or renew their membership. 

Pathways to Improving AdComms Membership

Committee Composition

The composition of Advisory Committees vary depending on the charter that has been set in place. In some cases, committee composition has been set by law. However, where there is flexibility in determining the composition of a committee, consideration should be given to all categories of expertise that should be included and diversity of voices that are selected to participate in these meetings. Committee composition should reflect the diversity of the world and populations of whom their recommendations could potentially affect. For this reason, discussions with current and former Advisory Committee members indicated the need for three additional areas of expertise that should be included on all Committees. Insights discovered that all Committees should include a patient representative who has the knowledge from lived experience and understanding of how treatments affect day-to-day life. This recommendation was further corroborated by a 3D Communications survey conducted with 400+ FDA AdComm members where results indicated that 48% agreed there should be a patient and consumer representative on all Committees. Members also stated that pharmacists should be included because drugs and devices eventually pass through their hands to give to patients. Pharmacologists should serve on the Committee due to their clinical application knowledge of drugs and devices. Finally, a roster of temporary members should be created for varying categories to use when additional expertise is needed on a Committee because of a conflict of interest or when a certain skillset or knowledge base is lacking on the current Committee. 

Role of the Advisory Committee Chair

The FDA describes the purpose of an Advisory Committee chair as one who will “preside at committee meetings and ensure that all rules of order and conduct are maintained during each session”. The chair also has the responsibility of ensuring all recommendations and advice from AdComm members are clear and evidence-based. Moreover, the role of the chair should be used to enhance the overall committee experience as well as be of service to the FDA. Despite these requirements, there’s an underutilization of the chair’s role in terms of communication and stakeholder coordination, as evidenced by the chair not being listed as a primary point of contact for the Advisory Committee and a lack of coordination amongst stakeholders.

Chairpersons are usually selected due to their critical domain knowledge, understanding of best practices, ability to identify risks and keep members engaged, and expansive relationships within their industry. Maximizing the chairperson’s role requires discussion on how to utilize their valuable domain knowledge and professional networks. Chairs possess extensive networks that could support the identification of permanent or temporary expert participants for AdComms, aiding the FDA’s mission to recruit top talent for guidance. This would ensure the FDA’s continued success in recruiting the brightest minds in the industry to assist with providing advice. Additionally, chairs should have oversight in identifying relevant issues or products for their respective committees to appraise, which can provide another layer for the FDA to keep abreast of critical public concerns via appropriate committee evaluation. 

Training

Training is a significant part of many Federal Government service positions. However, besides ethics and conflict of interest trainings, there is no set training program in place for most new Advisory Committee members. Considering Advisory Committee members come from different professional backgrounds with varying levels of expertise, the FDA should develop an onboarding training program to assist with acclimating all new AdComm members into their roles. Many former and current AdComm members mentioned that no formal training was provided as part of the onboarding process. Some members who were new to the FDA AdComm process or who were not physicians or scientists stated they had no knowledge of statistical analyses, clinical trial design, or how the FDA views the role of the AdComm in the regulatory process. 

A foundational training, covering these aspects, would greatly benefit those members such as consumer and patient representatives who may lack this shared base of expertise. An investment in such an onboarding experience would promote stronger rapport among members and guarantee their preparedness in analyzing scientific and technical submissions.

Learning about the FDA Regulatory Process

The Food & Drug Administration (FDA) was established with the purpose of regulating drugs and medical devices to ensure their safety and effectiveness for all citizens in the United States. Many Advisory Committee members join these committees without basic knowledge of the FDA’s regulatory process. During FAS’ discussions with current and former AdComm members, approximately 71% of members stated that basic knowledge of the regulatory process and how the FDA makes their decisions was unknown to them.

Providing AdComm members with an introductory course on the FDA’s regulatory process could enhance their comprehension, potentially allowing them to make more effective contributions and informed clinical decisions (based on their occupation). Although the FDA provides some online resources about its processes, like FAQs and guidelines, an expansion of this material should be considered for inclusion in AdComm orientation activities.  

Conflict of Interest (COI) Process

18 U.S.C. 208(a) prohibits Advisory Committee members who are designated as special government employees (SGE) from serving on federal advisory committees or any other Federal Government form of service that will have a “direct or predictable effect” on their financial interests. Similarly, the FDA describes a conflict of interest as an occurrence “when an individual selected to serve on an advisory committee has financial interests that may be impacted by the individual’s work on the advisory committee”. The auditing process for conflicts of interest is designed to confirm that the members of the advisory committee maintain impartiality and ensure the integrity of public health safety. Prior to any committee gathering, the FDA mandates that each participant, classified as either an AdComm member or SGE, complete an FDA 3410 form that reveals all financial connections that could be seen as potential COIs.

However, the process of what happens after the 3410 form has been completed is ambiguous. In 2007, the FDA submitted draft guidance to the federal register for comment entitled, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees in an effort to determine if there is an inappropriate COI that should exclude members from participating in a committee meeting. Moreover, the official guidance is not easily accessible. Another draft guidance was developed with a detailed listing of considerations to be given when examining conflict of interests can be found in the FDA’s draft guidance on Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.

Discussions with current and former AdComm members about the COI auditing process sparked varying views regarding whether flexibility should be exercised for COIs. 82% of members concurred that while they recognize the necessity for such a system, it tends to be overly demanding due to repetitive paperwork, especially when their circumstances remain unchanged. The strenuous nature of this routine has even deterred some from continuing their membership each year and remains a key aspect as to why members choose to end their service.

Despite having a COI process in place, there are loopholes that allow members with conflicts of interest to remain as voting members for specific AdComm meetings. A certain incident involved an Advisory Committee where 10 members who had financial ties to the sponsor were allowed to participate in an AdComm meeting. These individuals ultimately took part in endorsing the TriClip G4 System by Abbott and unanimously agreed that its benefits outweighed the potential risks. To further complicate matters, this information was not disclosed to the public at the time of approval.

While the COI process has resulted in members being rightfully disqualified from meetings due to actual or apparent conflicts, there is room to refine how these conflicts are identified and the standards employed to judge permissible COIs.

Policy Recommendations

In an effort to better leverage Advisory Committee membership, the potential policy recommendations are as follows:

Committee Composition

• If there is flexibility and committee composition is not bound by law, include a patient representative and pharmacist and/or pharmacologist on each Committee
  • Patient representatives provide a needed perspective due to lived experiences and understanding of how specific drugs and devices affect their day-to-day life
  • Drugs and devices will usually pass through the hands of pharmacists and pharmacologists. Therefore, they should have the opportunity to serve on these Committees and provide feedback. Pharmacologists also understand the clinical application of drugs. 
  • Develop a register of temporary members that can be utilized when additional expertise is needed for Committee meetings or when there is a conflict of interest (COI)

Role of the Chair

• Expand the role of the Committee chair that will encompass the task of recruiting both standing and ad hoc members, as well as identifying prominent issues and products for Committee consideration, thereby allowing for specialized input from their Committee  

Training and Regulatory Process

• Institute a basic 101 training for all newly appointed Advisory Committee members that covers statistical analysis, clinical trial design, and elucidates the partnership between the FDA and AdComm 
• Include an overview of the regulatory process and how the FDA’s decision-making process is performed

COI Auditing Process

• Develop a process that can quickly replace individuals who have a known conflict of interest
• Clearly delineate criteria for committee service acceptance regarding individuals with potential or actual conflicts of interest
• Streamline the COI process to prevent duplicative work that may act as a deterrent to experts volunteering to serve on the AdComm (work with GSA on this matter if necessary)

Conclusion

Advisory Committees are pivotal to maintaining trust with the public. It is essential for public safety to ensure that the most qualified experts are selected to serve on these Committees and that they have the tools to provide the FDA with informed and evidence-based recommendations. In an effort to increase public health safety, the FDA should enhance the AdComm structure by expanding the chair’s role, creating training programs for all new Advisory Committee members, and revising the conflict of interest procedures.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

Advisory Committees (AdComms) serve as the core for expert engagement in the Food and Drug Administration’s (FDA) decision-making processes. These committees are composed of medical professionals, industry representatives, patient advocates, and scientific experts. Their primary role is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. Public meetings led by the FDA with these committees are instrumental in facilitating transparent deliberation between the FDA, the advisory body, and the American public. This practice helps to cultivate a collaborative environment between the FDA, the AdComms, and the public. AdComm recommendations are integral to strengthening public trust and reinforcing the FDA’s credibility. This relationship is corroborated by aligning the counsel of these independent entities with the FDA’s regulatory actions.

Key Problems Facing Advisory Committees

A critical component of the AdComm structure is its voting mechanism, a method by which hand-selected experts offer expert advice or recommendations on questions that have been proposed by the FDA to assist with informing its formal, regulatory decision-making. These questions include a broad range of topics, from evaluating post-market safety data to assessing pre-market product risks and benefits, and gauging whether a product should be approved or withdrawn from the market. The outcomes of the votes serve as barometers for the AdComms official stance on products and provide the FDA with a comprehensive and collective viewpoint. However, the recommendations proposed by AdComms are suggestive rather than prescriptive; ultimately, leaving the final decision to FDA leadership. 

Recent patterns indicate a reduction in the convening of AdComm meetings. In 2010, 55% of FDA-approved drugs were referred to an advisory committee. By 2021, the percentage of FDA-approved drugs with an advisory committee referral had dropped to 6%. The decline of meetings eliminates opportunities for evidence-based evaluation and deliberation that could potentially affect the health and well-being of Americans. Furthermore, the diminishing of these crucial interactions between the FDA, AdComms and the public exacerbates the lack of trust and erodes transparency. Interestingly, while most committees present definitive votes that are supported by explicit justifications for either approving or rejecting items under review, FDA Commissioner Robert Califf has suggested in multiple interviews that AC votes can be useful but are not mandatory for every meeting. This viewpoint raises concerns about the potential removal of voting from the reform agenda, which could undermine AdComms capacity to evaluate intricate topics that affect the American public consumer base. In addition, a survey conducted by 3D Communications with 400+ current and former AdComm members asked about the importance of voting. Results showed that 95% of AdComm members believe that voting should be retained when reviewing the benefits and risks of medical products. Reform discussions have materialized due to these factors, in addition to the FDA’s accelerated approval of Adulhelm (aducanumab) despite clear AdComm opposition. Demand for reform is inevitable and many are urging for there to be an increased number of AC meetings and a thorough reorganization of advisory committee operations and voting protocols. Such reform is not only administrative but also symbolic. This type of reform confirms that decisions affecting public health should be informed and shaped by multidisciplinary expertise. Additionally, it re-establishes the pivotal role of public input in regulatory affairs, which is an indispensable component to maintaining the American public’s trust.

Significance of AdComm Voting

In response to this call for AdComm reform, a project spearheaded by FAS has sought feedback from AdComm members regarding their views on the significance of voting. The intention of engagement is to understand members’ experiences as experts and their perspectives on voting by asking the following questions:

• Describe your Advisory Committee’s voting process.
• On a 1-5 scale, how crucial is it for you to vote on products?

These questions aimed to measure the variability in voting mechanisms across committees and the value members place on voting. Results from 30 participants demonstrate a consensus on the critical role of voting in formulating committee recommendations, with 87% of committee members indicating a five (very important) as their stance on the importance of voting.

Policy Recommendations

To uphold the FDA’s integrity and regain public confidence, retaining voting at AdComm meetings is essential in addition to other recommendations to enhance the advisory committee process. The recommendations are as follows: 

• Maintain voting as an integral function, allowing FDA Advisory Committee members to convey their collective expertise and advice, aiding the FDA in informed decision-making on scientific and regulatory matters. 
• Revise the guidance for FDA Advisory Committee Members and FDA Staff to explicitly define circumstances for which voting should occur, eliminate sequential voting

Conclusion

The recommendations of FDA Advisory Committee members are a pivotal component to the FDA’s regulatory decision-making process. Maintaining the voting protocol for Advisory Committee meetings is essential as members strive toward the continued provision of precise, impartial, and evidence-based counsel to the FDA. This voting mechanism guarantees the inclusion of each member’s perspective and ensures that an official committee stance is taken, offering the FDA definitive and straightforward guidance.

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.