The federal government transfers approximately $1.1 trillion dollars every year to state and local governments. Yet most states and localities are not evaluating whether the programs deploying these funds are increasing community well-being. Similarly, achieving important national goals like increasing clean energy production and transmission often requires not only congressional but also state and local policy reform. Yet many states and localities are not implementing the evidence-based policy reforms necessary to achieve these goals.

State and local government innovation is a problem not only of politics but also of capacity. State and local governments generally lack the technical capacity to conduct rigorous evaluations of the efficacy of their programs, search for reliable evidence about programs evaluated in other contexts, and implement the evidence-based programs with the highest chances of improving outcomes in their jurisdictions. This lack of capacity severely constrains the ability of state and local governments to use federal funds effectively and to adopt more effective ways of delivering important public goods and services. To date, efforts to increase the use of evaluation evidence in federal agencies (including the passage of the Evidence Act) have not meaningfully supported the production and use of evidence by state and local governments.

Despite an emerging awareness of the importance of state and local government innovation capacity, there is a shortage of plausible strategies to build that capacity. In the words of journalist Ezra Klein, we spend “too much time and energy imagining the policies that a capable government could execute and not nearly enough time imagining how to make a government capable of executing them.”

Yet an emerging body of research is revealing that an effective strategy to build government innovation capacity is to partner government agencies with local universities on scientifically rigorous evaluations of the efficacy of their programs, curated syntheses of reliable evaluation evidence from other contexts, and implementation of evidence-based programs with the best chances of success. Leveraging these findings, along with recent evidence of the striking efficacy of the national network of university-based “Agriculture Experiment Stations” established by the Hatch Act of 1887, we propose a national network of university-based “Policy Experiment Stations” or policy innovation labs in each state, supported by continuing federal and state appropriations and tasked with accelerating state and local government innovation.  

Challenge

Advocates of abundance have identified “failed public policy” as an increasingly significant barrier to economic growth and community flourishing. Of particular concern are state and local policies and programs, including those powered by federal funds, that do not effectively deliver critically important public goods and services like health, education, safety, clean air and water, and growth-oriented infrastructure.

Part of the challenge is that state and local governments lack capacity to conduct rigorous evaluations of the efficacy of their policies and programs. For example, the American Rescue Plan, the largest one-time federal investment in state and local governments in the last century, provided $350 billion in State and Local Fiscal Recovery Funds to state, territorial, local, and Tribal governments to accelerate post-pandemic economic recovery. Yet very few of those investments are being evaluated for efficacy. In a recent survey of state policymakers, 59% of those surveyed cited “lack of time for rigorous evaluations” as a key obstacle to innovation. State and local governments also typically lack the time, resources, and technical capacity to canvass evaluation evidence from other settings and assess whether a program proven to improve outcomes elsewhere might also improve outcomes locally. Finally, state and local governments often don’t adopt more effective programs even when they have rigorous evidence that these programs are more effective than the status quo, because implementing new programs disrupts existing workflows. 

If state and local policymakers don’t know what works and what doesn’t, and/or aren’t able to overcome even relatively minor implementation challenges when they do know what works, they won’t be able to spend federal dollars more effectively, or more generally to deliver critical public goods and services.

Opportunity

A growing body of research on government innovation is documenting factors that reliably increase the likelihood that governments will implement evidence-based policy reform. First, government decision makers are more likely to adopt evidence-based policy reforms when they are grounded in local evidence and/or recommended by local researchers. Boston-based researchers sharing a Boston-based study showing that relaxing density restrictions reduces rents and house prices will do less to convince San Francisco decision makers than either a San Francisco-based study, or San Francisco-based researchers endorsing the evidence from Boston. Proximity matters for government innovation.

Second, government decision makers are more likely to adopt evidence-based policy reforms when they are engaged as partners in the research projects that produce the evidence of efficacy, helping to define the set of feasible policy alternatives and design new policy interventions. Research partnerships matter for government innovation.

Third, evidence-based policies are significantly more likely to be adopted when the policy innovation is part of an existing implementation infrastructure, or when agencies receive dedicated implementation support. This means that moving beyond incremental policy reforms will require that state and local governments receive more technical support in overcoming implementation challenges. Implementation matters for government innovation. 

We know that the implementation of evidence-based policy reform produces returns for communities that have been estimated to be on the order of 17:1. Our partners in government have voiced their direct experience of these returns. In Puerto Rico, for example, decision makers in the Department of Education have attributed the success of evidence-based efforts to help students learn to the “constant communication and effective collaboration” with researchers who possessed a “strong understanding of the culture and social behavior of the government and people of Puerto Rico.” Carrie S. Cihak, the evidence and impact officer for King County, Washington, likewise observes, 

“It is critical to understand whether the programs we’re implementing are actually making a difference in the communities we serve. Throughout my career in King County, I’ve worked with  County teams and researchers on evaluations across multiple policy areas, including transportation access, housing stability, and climate change. Working in close partnership with researchers has guided our policymaking related to individual projects, identified the next set of questions for continual learning, and has enabled us to better apply existing knowledge from other contexts to our own. In this work, it is essential to have researchers who are committed to valuing local knowledge and experience–including that of the community and government staff–as a central part of their research, and who are committed to supporting us in getting better outcomes for our communities.” 

The emerging body of evidence on the determinants of government innovation can help us define a plan of action that galvanizes the state and local government innovation necessary to accelerate regional economic growth and community flourishing. 

Plan of Action 

An evidence-based plan to increase state and local government innovation needs to facilitate and sustain durable partnerships between state and local governments and neighboring universities to produce scientifically rigorous policy evaluations, adapt evaluation evidence from other contexts, and develop effective implementation strategies. Over a century ago, the Hatch Act of 1887 created a remarkably effective and durable R&D infrastructure aimed at agricultural innovation, establishing university-based Agricultural Experiment Stations (AES) in each state tasked with developing, testing, and translating innovations designed to increase agricultural productivity. 

Locating university-based AES in every state ensured the production and implementation of locally-relevant evidence by researchers working in partnership with local stakeholders. Federal oversight of the state AES by an Office of Experiment Stations in the US Department of Agriculture ensured that work was conducted with scientific rigor and that local evidence was shared across sites. Finally, providing stable annual federal appropriations for the AES, with required matching state appropriations, ensured the durability and financial sustainability of the R&D infrastructure. This infrastructure worked: agricultural productivity near the experiment stations increased by 6% after the stations were established.

Congress should develop new legislation to create and fund a network of state-based “Policy Experiment Stations.”

 The 119th Congress that will convene on January 3, 2025 can adapt the core elements of the proven-effective network of state-based Agricultural Experiment Stations to accelerate state and local government innovation. Mimicking the structure of 7 USC 14, federal grants to states would support university-based “Policy Experiment Stations” or policy innovation labs in each state, tasked with partnering with state and local governments on (1) scientifically rigorous evaluations of the efficacy of state and local policies and programs; (2) translations of evaluation evidence from other settings; and (3) overcoming implementation challenges. 

As in 7 USC 14, grants to support state policy innovation labs would be overseen by a federal office charged with ensuring that work was conducted with scientific rigor and that local evidence was shared across sites. We see two potential paths for this oversight function, paths that in turn would influence legislative strategy.

Pathway 1: This oversight function could be located in the Office of Evaluation Sciences (OES) in the General Services Administration (GSA). In this case, the congressional committees overseeing GSA, namely the House Committee on Oversight and Responsibility and the Senate Committee on Homeland Security and Governmental Affairs, would craft legislation providing for an appropriation to GSA to support a new OES grants program for university-based policy innovation labs in each state. The advantage of this structure is that OES is a highly respected locus of program and policy evaluation expertise. 

Pathway 2: Oversight could instead be located in the Directorate of Technology, Innovation, and Partnerships in the National Science Foundation (NSF TIP). In this case, the House Committee on Science, Space, and Technology and the Senate Committee on Commerce, Science, and Transportation would craft legislation providing for a new grants program within NSF TIP to support university-based policy innovation labs in each state. The advantage of this structure is that NSF is a highly respected grant-making agency. 

Either of these paths is feasible with bipartisan political will. Alternatively, there are unilateral steps that could be taken by the incoming administration to advance state and local government innovation. For example, the Office of Management and Budget (OMB) recently released updated Uniform Grants Guidance clarifying that federal grants may be used to support recipients’ evaluation costs, including “conducting evaluations, sharing evaluation results, and other personnel or materials costs related to the effective building and use of evidence and evaluation for program design, administration, or improvement.” The Uniform Grants Guidance also requires federal agencies to assess the performance of grant recipients, and further allows federal agencies to require that recipients use federal grant funds to conduct program evaluations. The incoming administration could further update the Uniform Grants Guidance to direct federal agencies to require that state and local government grant recipients set aside grant funds for impact evaluations of the efficacy of any programs supported by federal funds, and further clarify the allowability of subgrants to universities to support these impact evaluations.

Conclusion

Establishing a national network of university-based “Policy Experiment Stations” or policy innovation labs in each state, supported by continuing federal and state appropriations, is an evidence-based plan to facilitate abundance-oriented state and local government innovation. We already have impressive examples of what these policy labs might be able to accomplish. At MIT’s Abdul Latif Jameel Poverty Action Lab North America, the University of Chicago’s Crime Lab and Education Lab, the University of California’s California Policy Lab, and Harvard University’s The People Lab, to name just a few, leading researchers partner with state and local governments on scientifically rigorous evaluations of the efficacy of public policies and programs, the translation of evidence from other settings, and overcoming implementation challenges, leading in several cases to evidence-based policy reform. Yet effective as these initiatives are, they are largely supported by philanthropic funds, an infeasible strategy for national scaling.

In recent years we’ve made massive investments in communities through federal grants to state and local governments. We’ve also initiated ambitious efforts at growth-oriented regulatory reform which require not only federal but also state and local action. Now it’s time to invest in building state and local capacity to deploy federal investments effectively and to galvanize regional economic growth. Emerging research findings about the determinants of government innovation, and about the efficacy of the R&D infrastructure for agricultural innovation established over a century ago, give us an evidence-based roadmap for state and local government innovation.

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

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

Current hiring processes for political appointees are opaque and problematic; job openings are essentially closed off except to those in the right networks. To democratize hiring, the next administration should develop a public jobs board for non-Senate-confirmed political appointments, which includes a list of open roles and job descriptions. By serving as a one-stop shop for those interested in serving in an administration, an open jobs board would bring more skilled candidates into the administration, diversify the appointee workforce, expedite the hiring process, and improve government transparency.

Challenge and Opportunity

Hiring for federal political appointee positions is a broken process. Even though political appointees steer some of the federal government’s most essential functions, the way these individuals are hired lacks the rigor and transparency expected in most other fields.

Political appointment hiring processes are opaque, favoring privileged candidates already in policy networks. There is currently no standardized hiring mechanism for filling political appointee roles, even though new administrations must fill thousands of lower-level appointee positions. Openings are often shared only through word-of-mouth or internal networks, meaning that many strong candidates with relevant domain expertise may never be aware of available opportunities to work in an administration. Though the Plum Book (an annually updated list of political appointees) exists, it does not list vacancies, meaning outside candidates must still have insider information on who is hiring.

These closed hiring processes are deeply problematic because they lead to a non-diverse pool of applicants. For example, current networking-based processes benefit graduates of elite universities, and similar networking-based employment processes such as employee referral programs tend to benefit White men more than any other demographic group. We have experienced this opaque process firsthand at the Aspen Tech Policy Hub; though we have trained hundreds of science and technology fellows who are interested in serving as appointees, we are unaware of any that obtained political appointment roles by means other than networking.

Appointee positions often do not include formal job descriptions, making it difficult for outside candidates to identify roles that are a good fit. Most political appointee jobs do not include a written, formalized job description—a standard best practice across every other sector. A lack of job descriptions makes it almost impossible for outside candidates utilizing the Plum Book to understand what a position entails or whether it would be a good fit. Candidates that are being recruited typically learn more about position responsibilities through direct conversations with hiring managers, which again favors candidates who have direct connections to the hiring team.

Hiring processes are inefficient for hiring staff. The current approach is not only problematic for candidates; it is also inefficient for hiring staff. Through the current process, PPO or other hiring staff must sift through tens of thousands of resumes submitted through online resume bank submissions (e.g. the Biden administration’s “Join Us” form) that are not tailored to specific jobs. They may also end up directly reaching out to candidates that may not actually be interested in specific positions, or who lack required specialized skills.

Given these challenges, there is significant opportunity to reform the political appointment hiring process to benefit both applications and hiring officials.

Plan of Action

The next administration’s Presidential Personnel Office (PPO) should pilot a public jobs board for Schedule C and non-career Senior Executive Service political appointment positions and expand the job board to all non-Senate-confirmed appointments if the pilot is successful. This public jobs board should eventually provide a list of currently open vacancies, a brief description for each currently open vacancy that includes a job description and job requirements, and a process for applying to that position.

Having a more transparent and open jobs board with job descriptions would have multiple benefits. It would:

• Bring in more diverse applicants and strengthen the appointee workforce by broadening hiring pools; 
• Require hiring managers to write out job descriptions in advance, allowing outside candidates to better understand job opportunities and hiring managers to pinpoint qualifications they are looking for; 
• Expedite the hiring process since hiring managers will now have a list of qualified applicants for each position; and 
• Improve government transparency and accessibility into critical public sector positions.

Additionally, an open jobs board will allow administration officials to collect key data on applicant background and use these data to improve recruitment going forward. For example, an open application process would allow administration officials to collect aggregate data on education credentials, demographics, and work experience, and modify processes to improve diversity as needed. Having an updated, open list of positions will also allow PPO to refer strong candidates to other open roles that may be a fit, as current processes make it difficult for administration officials or hiring managers to know what other open positions exist.

Implementing this jobs board will require two phases: (1) an initial phase where the transition team and PPO modify their current “Join Us” form to list 50-100 key initial hires the administration will need to make; and (2) a secondary phase where it builds a more fulsome jobs board, launched in late 2025, that includes all open roles going forward. 

Phase 1. By early 2025, the transition team (or General Services Administration, in its transition support capacity) should identify 50-100 key Schedule C or non-career Senior Executive service hires they think the PPO will need to fill early in the administration, and launch a revised resume bank to collect applicants for these positions. The transition team should prioritize roles that a) are urgent needs for the new administration, b) require specialized skills not commonly found among campaign and transition staff (for instance technical or scientific knowledge), and c) have no clear candidate already identified. The transition team should then revise the current administration’s “Join Us” form to include this list of 50-100 soon-to-be vacant job roles, as well as provide a 2-3 sentence description of the job responsibilities, and allow outside candidates to explicitly note interest in these positions. This should be a relatively light lift, given the current “Join Us” form is fairly easy to build.

Phase 2. Early in the administration, PPO should build a larger, more comprehensive jobs board that should aim to go live in late 2025 and includes all open Schedule C or non-Senior Executive Service (SES) positions. Upon launch, this jobs board should include open jobs for whom no candidate has been identified, and any new Schedule C and non-SES appointments that are open going forward. As described in further detail in the FAQ section, every job listed should include a brief description of the position responsibilities and qualifications, and additional questions on political affiliation and demographics.

During this second phase, the PPO and the Office of Personnel Management (OPM) should identify and track key metrics to determine whether it should be expanded to cover all non-Senate confirmed appointments. For example, PPO and OPM could compare the diversity of applicants, diversity of hires, number of qualified candidates who applied for a position, time-to-hire, and number of vacant positions pre- and post-implementation of the jobs board. 

If the jobs board improves key metrics, PPO and OPM should expand the jobs board to all non-Senate confirmed appointments. This would include non-Senate confirmed Senior Executive Service appointee positions.

Conclusion

An open jobs board for political appointee positions is necessary to building a stronger and more diverse appointee workforce, and for improving government transparency. An open jobs board will strengthen and diversify the appointee workforce, require hiring managers to specifically write down job responsibilities and qualifications, reduce hiring time, and ultimately result in more successful hires.

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

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

How hard can it be to hire into the federal government? Unfortunately, for many, it can be very challenging. A recent conversation with a hiring manager at a federal regulatory agency, shed light on some of the difficulties experienced in the hiring process.

A Hiring Experience

This hiring manager – let’s call her Alex – needed to hire someone to join her team and support environmental review efforts (e.g., reviewing the impact of building a road near a wetland) towards the end of 2023. It was a position she had hired for previously, and she had a strong understanding of the skills and knowledge that a candidate would need to be successful in the role. 

Luckily, she did not need to create a new job description, classify the position, or create a new assessment. Instead, she was able to use the previous job description, job analysis, and assessment, only making small tweaks. This meant that she just needed to work with the HR Specialist (personnel who provide human resource management services within their agency) to finalize the Job Opportunity Announcement (JOA). 

This was happening in December and given the holidays, she decided to wait on posting the JOA until the new year. They posted the announcement in early January and closed the application a week later. Alex publicized the opening through her network on LinkedIn and through other LinkedIn pages.

Anxious to bring a new teammate on board, Alex was quite frustrated to not receive a certified list of candidates from the HR Specialist until four months later. And when she began her review of the candidates, she was surprised to find only one applicant with the experience and skills she was looking for in the role. Alex reached out to the candidate, but learned that they had already accepted a different role.

Feeling disheartened, Alex contacted the HR Specialist to ask for a second list of candidates, explaining the incompatibility of the other applicants in the initial list. Alex waited until June to receive the second list, now six months past the posting date, but she was excited to see several qualified candidates for the role. 

Following their evaluation process, Alex made an offer to a candidate from the list. With the tentative offer accepted, they started the background check, which took about two months. The candidate finally started in September, nine months after posting the position.

Now, what happened? Why did it take nine months to fill this position, especially when the job announcement only required small changes?

Mapping the Hiring Process

In our recent blog post, we shared how difficult it is to hire into the federal government and cited a number of different challenges (e.g., outdated job descriptions, reclassifying roles, defining an assessment strategy, etc.) hindering the government from building talent capacity. We decided to map out the federal government’s competitive hiring process to illustrate how the hiring process typically works and where pain points often emerge. Through research (e.g., OPM’s Hiring Process Analysis Tool), expert feedback, and practitioner discussions (e.g., interviews with hiring managers, HR specialists, and leaders involved in permitting activities), we outlined the main steps of the hiring process from workforce planning through candidate selection and onboarding. And we found the process to look similar to a game of Chutes and Ladders. 

As you’ll see, the hiring process is divided into four major phases: (1) aligning the workforce plan and validating the hiring need, (2) developing and posting a job opportunity announcement, (3) assessing the candidates, and (4) selecting a candidate and making an offer. Distributed throughout this process, we identified nine primary pain points that drive the majority of delays experienced by civil servants.

See full-sized, interactive map here

In the first phase, the major challenges experienced are receiving the funding to begin the hiring process and realigning the workforce plan to account for the new role, especially when there is a talent surge that was unanticipated. In the case of environmental permitting, the Inflation Reduction Act (IRA) and Bipartisan Infrastructure Law (BIL) provided significant funding to support talent acquisition, but agencies had not planned for the talent surge. These new talent needs did not align with their existing workforce plans nor their capacity to recruit, source, assess, and bring new staff onboard. 

Additionally, budget availability has also caused a number of delays. The new legislation only provides short-term funding for talent or in other cases, is unclear how the funds can be used for staffing. As a result, agencies have hesitated in hiring. They are left weighing the tradeoffs of hiring for full time employees with uncertain future funding or hiring for term positions (i.e., roles with a limited duration). Analyzing retention and retirement rates have helped some agencies navigate this decision, but the desire to avoid future layoffs combined with the risk averse culture has made the process difficult. Some have decided to hire for term positions, but have struggled in recruiting talent interested in a short-term role. Ultimately, this short-term funding does not help address long-term talent capacity gaps.

In the second phase of the process, the pain points center around developing and preparing the final job opportunity announcement (JOA). This can be delayed if there is not a position description that accurately captures the role, there is not a strong assessment strategy, or the HR Specialist and Hiring Manager disagree on the language to be used in the announcement. 

With permitting-related positions, many agencies have been looking to hire for interdisciplinary positions that have a range of expertise. OPM, the Permitting Council, and agencies have worked to create interdisciplinary position descriptions and announcements across technical disciplines. Developing the job descriptions, confirming the job duties, and formulating an assessment strategy takes more time, ultimately resulting in a longer time to hire. 

Even for positions that are more regularly used across agencies (e.g., Environmental Protection Specialist) descriptions may be available and up to date, but there may not be an assessment for a particular grade. For example, OPM and the Permitting Council collaborated to create a pooled hiring, cross-government announcement for a multi-grade Environmental Protection Specialist (EPS). This allowed for one JOA to produce a list of candidates that many agencies could use for hiring. Yet the assessment remained somewhat of a bottleneck because there were not standard assessments available for each grade (e.g., GS-5-14) in the JOA, which required more time for assessment development. This is not unique; for many positions, standard assessments do not exist for each grade.

In the third phase, the primary challenge is a lack of qualified candidates. Hiring managers receive a list of candidates (i.e., certificate list) who should meet the requirements of the position, but that is not always the case. This can result from a number of issues ranging from the use of self-assessments and HR Specialists lacking the expertise to screen resumes to insufficient recruiting efforts. 

In discussions with civil servants looking to hire for permitting-related positions, we have heard these challenges. Some agencies have struggled to make time for efforts given their limited capacity, resulting in a limited applicant pool. Alex’s story provides another example. Alex and their HR Specialist selected a self-assessment strategy, where applicants report their level of experience and skills on a number of questions related to the role. Both self-inflation and humility can distort these scores, resulting in qualified candidates not making it through the process. In reviewing the first certification list, Alex explained being surprised to see individuals with resumes unrelated to the role. This likely resulted from inaccurate self-assessment scores combined with a lack of expertise among the HR Specialist to effectively screen the resumes for the position. Receiving a certificate list with unqualified candidates can significantly delay the process, and in Alex’s case, result in another two month delay.

In the last phase of the process, delays often result from candidates declining their offer and the time required for background checks. Candidate declines can be very demotivating for a Hiring Manager who is excited to bring on the candidate they selected. Candidate declinations are a challenge for permitting-related positions. This is often due to constraints in negotiating salaries and relocation requirements, especially when candidates are asked to move to an area with a high cost of living. With today’s high interest rates, some candidates are just unable to move given the federal government’s stagnant pay structure. 

Improving Alex’s Experience

Thinking back to Alex, this process highlights some areas where the process went astray, particularly with the assessment and HR Specialist screening. These issues can be solved through skills-based hiring and better assessment tools such as Subject Matter Expert Qualification Assessment (SME-QA) (i.e., a process that incorporates subject matter expert resume reviews into the screening process). However, an often-overlooked challenge, not highlighted in the process map, is the relationship between the Hiring Manager and HR Specialist. 

The breakdown in communication between HR Specialists and Hiring Managers is not uncommon. Building a strong relationship and shared ownership across the hiring process is key to success. In Alex’s case, she was discouraged from reaching out to the HR Specialist with questions because of the HR team’s limited capacity; the team was centralized across their organization and responsible for servicing many offices. This left Alex frustrated. The process felt like a black box, leaving her with no insight as she waited for her certificate list to eventually arrive. A kickoff meeting with the HR Specialist to align on a timeline, establish roles and responsibilities, and form a line of communication to share updates throughout the process could have helped open and shine light in the black box, fostering a collaborative relationship to identify and mitigate issues as they arose throughout the process.

Summary

When we take a step back and look at this hiring process, it can feel daunting. The average time to hire one candidate is 101 days. In comparison, the private sector takes less than half the time. While it may not be possible for this current process to meet the private sector’s timeline, there are things that can be done to streamline today’s process. In our next series of blog posts, we will dive into each phase in more detail and highlight short-term solutions for hiring managers, HR specialists, program managers, and budget personnel to bypass these chutes — and focus on the ladders.

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 for the executive level, for the executive level, that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. In this toolkit, we build off of those discussions by providing you with actionable policy reform recommendations. We hope that these recommendations catapult the Advisory Committee structure into one best suited to equip all AdComms with the necessary tools needed to continue providing the government with the best advice.

Download a PDF version of these recommendations on the left.

Recommendations and Best Practices for Actionable Policy Implementation

Voting for FDA Advisory Committees

Update Type: Process

• 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 and eliminate sequential voting

Best Practices for Implementation 

The United States Food and Drug Administration can uphold their voting mechanism by updating their document entitled, “Guidance for FDA Advisory Committee members and FDA staff: Voting Procedures for Advisory Committee Meetings” to include language that clearly states a vote should be taken at all Advisory Committee meetings where a medical product is being reviewed. This guidance should also indicate that the absence of voting should only occur if an Advisory Committee meeting has been convened to discuss issues of policy. Further, this guidance should be considered a level 2 guidance as it falls into the category of addressing a “controversial issue”. To effectuate these changes, a notice of availability (NOA) may be submitted to the Federal Register for public input (public input is not a requirement before implementation). 

Potential Language to be Utilized for Guidance 

In an effort to continue to allow Advisory Committee members to provide unbiased, evidence-based feedback and uphold such an integral part of the Advisory Committee process, voting is hereby mandatory for all Advisory Committee meetings that are convened where the purpose is to review and assess the safety and efficacy of medical products. 

Involved Stakeholders

In order for this process to successfully occur, the FDA will need to amend their guidance with the aforementioned updates. Consideration should be given to incurred costs for personnel required to complete these updates. Personnel needed for these amendments may include, but are not limited to, the (a) Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, (b) Center for Devices and Radiological Health, (c) Center for Biologics Evaluation and Research, and (d) Center for Drug Evaluation and Research.

FDA Staff, Leadership, and AdComm Disagreements

Update Type: Process

• 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.
• Develop guidance that clearly explains a transparent process to communicate effectively with AdComm members regarding decision making when parties have opposing viewpoints

Best Practices for Implementation 

Implementing these recommendations will improve conflict resolution internally and between the Agency and Advisory Committee members. Best practices for implementation include (a) building the Scientific Dispute Resolution at FDA guidance into the official FDA onboarding process for new hires to raise awareness, (b) provide annual employee trainings in an effort to stay up-to-date with dispute resolution processes and procedures, and (c) develop a guidance that delineates the process for resolving conflicts between the Agency and Advisory Committees when there are differing opinions. 

Note: Guidance for resolving disputes between the Agency and Advisory Committees should be submitted to the Federal Register for public comment. Guidance should also include plain language that designates the avenue to be used for official decision notifications, the timeliness of these notifications after convenings have concluded, and circumstances in which the FDA cannot notify Advisory Committees that their decision is in direct opposition of the Committee’s vote (e.g., – if this notification would breach a confidentiality agreement with the applicant). 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.

Involved Stakeholders 

Successful implementation of these recommendations will require the capacity of human resources personnel and individual center leadership. 

Update Type: Regulatory

• Incorporate the Scientific Dispute Resolution at FDA guidance into FDA regulations
• Amend the Scientific Dispute Resolution at FDA guidance to dictate the mandatory execution of best practices within the dispute resolution process
  • 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. 

Best Practices for Implementation

Center leadership can assign FDA staff to make the necessary guidance amendments which should include the requirements for inclusion in the onboarding of all FDA employees. Staff should also be responsible for obtaining feedback on amendments from all necessary internal parties and submitting proposed amendments to OMB for review and addition to the Federal Register. Federal register comments will then be reviewed by FDA staff, guidance will be updated accordingly, and a final draft submitted to OMB for review. If approved, the final regulation will be published in the Code of Federal Regulations. Congressional involvement should not be necessary.

FDA Center leadership should delegate the task of creating an annual mandatory training program for all FDA employees to review this guidance in an effort to stay abreast of the procedures for dispute resolution. 

Involved Stakeholders 

FDA Center leadership, FDA staff, and the Office of Management and Budget (OMB) are the intended stakeholders for implementation of these recommendations. To incorporate this guidance into FDA regulations, Center leadership will need to assign FDA staff to amend guidance and submit to OMB.

Leveraging AdComm Membership

Update Type: Process

Expanding Committee Representation

• 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. 
  • Have a roster of temporary members that can be used when additional expertise is needed for Committee meetings or when there is a conflict of interest (COI)

Amplifying the 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  

Establishing Training and Regulatory Procedures for Incoming Members

• 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

Best Practices for Implementation

With respect to Committee composition, the FDA should consider adding patient representatives to all Committees that review medical products. The addition of a patient representative will ensure that the voice of the population who the medical product affects is heard. The FDA can select individuals best suited to fill these roles through connecting with patient advocacy organizations. If patient representatives are selected, the FDA should develop an onboarding program to familiarize the patient representative with basic knowledge of the federal regulation process. This program should educate the patient representative on (a) the types of questions presented to Advisory Committees, (b) how the FDA views the role of the patient representative in the process, (c) the internal review process for data that is submitted, and (d) other pertinent topics related to medical product regulation.

Leveraging the role of the Advisory Committee Chair can help the FDA fully optimize the use of their Committee. “Chairs possess extensive networks that could support the identification of permanent or temporary expert participants for AdComms” (Banks, 2024). Allowing Chairs the ability to identify relevant issues or products for their respective committees to review can provide an additional layer for the FDA to keep abreast of critical public concerns via appropriate committee evaluation (Banks, 2024).

Finally, while Committee members may be experts in their own right, training should be provided for all. The FDA should provide basic 101 training courses that can cater to the needs of members with various knowledge bases. Training should include information on the relationship between the FDA and Advisory Committee members, best practices for understanding statistical analysis, and the different types of clinical trial designs. Training should provide real-world examples of statistical analysis and trial design in use (this can be done by providing examples from prior medical product review). 

Involved Stakeholders

FDA Center staff (including statisticians and scientists for the development of training programs).

Conflict of Interest (COI) Auditing

UPDATE TYPE: 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 actualconflicts of interest

Best Practices for Implementation

To prevent recurring COIs, the FDA should develop a database of experts for various categories of expertise that can be selected to replace those with known COIs. This database should include names, contact information, credentials, all areas of expertise for each expert, and should link to public financial interest databases that can serve as a source for identifying conflicts (e.g., Open Payments, Dollars for Docs).

To prevent public confusion, the FDA should amend their Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers to specify circumstances that warrant a COI waiver being administered. This will increase transparency and help Advisory Committee members and the public understand the reasoning in allowing members with conflicts to participate in meetings. This guidance can then be submitted to the Federal Register for public comment

UPDATE TYPE: PROCESS | REGULATORY

• 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)

Best Practices for Implementation

Streamlining the COI process will assist the FDA with retention efforts for Advisory Committees while maintaining compliance with conflict of interest regulations. A digital system should be developed that allows Advisory Committee members to select whether their financial information has changed through the use of a dropdown or check box. This will prevent duplicative work and also contribute to a sustainable (green) process.

Involved Stakeholders

The Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy would be the interested stakeholder to issue updates to the COI policy and would work with the General Services Administration if necessary. 

The Role of Patient Advocacy in the AdComm Process

Update Type: Process

• 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

Best Practices for Implementation

Public comments are a crucial part of the regulatory process. The FDA should focus on increasing participation in this process, as well as notifying participants of what should be expected from the public comment period. By law, the FDA must allow a public comment period for all Advisory Committee convenings. To increase participation, the FDA should allow public comments to be vocalized in-person and virtually, in addition to the submission of public comments to the docket. 

Regarding Committee composition, please refer to Best Practices for Implementation under Leveraging AdComm Membership for information on the addition of patient representatives to Advisory Committees (see prior section above).

Patient engagement in the regulatory process is necessary to inform evidence-based decisions. While the FDA currently has ways to engage these communities through the use of public comment and initiatives such as Patient Focused Drug Development (PFDD), engagement should be an ongoing process. As mentioned, the FDA can develop and leverage existing relationships with public health agencies and advocacy organizations who can then serve as the liaison of feedback to the FDA. The FDA can also consider expanding their current initiatives and programs to engage communities twice a quarter instead of quarterly or annually. Consistent engagement in this form will help to establish trust between the FDA and the public who they serve, as well as give them the needed information from the communities who are most impacted from their decisions.  

Involved Stakeholders

Implementation of these recommendations and expansion of current initiatives will require the involvement of FDA Center leadership and Center staff.

Improving Public Awareness and Understanding of Advisory Committees

Update Type: Process

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

Best Practices for Implementation

The FDA should develop a monthly content plan to utilize its current interactive and social media outlets and disseminate information related to the role of Advisory Committees and their convenings, while also maintaining compliance with the FDA’s social media policy. The social media content plan should be centered around (a) what an Advisory Committee is, (b) how members are selected, (c) information regarding votes of Advisory Committees and how they are specific to safety and efficacy, but are not voting on the approval of a medical product, (d) discussing upcoming Advisory Committee meetings, their location, and inviting the public to participate via public comment, (e) sharing information about what a public comment is, requirements for making public comments, and how the FDA reviews them, and (f) sharing a webpage where the general public can input their personal email to be notified of upcoming Advisory Committee meetings.

FDA staff should develop a plain language disclaimer to be placed on all social media posts, meeting materials, and websites related to Advisory Committees. This disclaimer should illustrate that Advisory Committee members will provide unbiased expertise to assist the FDA with their decision. However, while the Committee’s vote is included in consideration for the decision, their vote is non-binding which leaves the FDA as the final decision maker for approval.

Finally, the FDA should identify state/local public health agencies, as well as advocacy organizations that they can potentially partner with to disseminate information more broadly. These agencies and advocacy organizations have strong relationships with various communities who should be engaged in the regulatory process. Developing a relationship with these agencies and organizations in an attempt to engage the community will assist the FDA with building connections and trust, as well as mutual understanding of Advisory Committee roles. Potential partners can be identified using the linked list under involved stakeholders. 

Involved Stakeholders

Implementation of these recommendations and expansion of current initiatives will require the involvement of FDA Center leadership, Center staff, Office of External Affairs (OEA) Web and Digital Media staff, Office of Information Management and Technology (OIMT), state/local public health departments, and advocacy organizations.

Note: These listings of state/local public health departments and advocacy organizations are intended to be used as a starting point in the identification of potential partners and not to be considered an exhaustive list.

For questions related to this toolkit, please contact

Cheri Banks
Health Regulatory Specialist
cbanks@fas.org

Grace Wickerson
Health Equity Policy Manager
gwickerson@fas.org