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  4. Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees - 06/13/2024
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Meeting | Virtual

Event Title
Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees
June 13, 2024

Listening Session

Date:
June 13, 2024
Time:
9:00 a.m. - 4:00 p.m. ET

The FDA will hold a virtual listening session on June 13, 2024. 

The purpose of the listening session is to solicit feedback on the Agency’s use of and processes for its advisory committee system.   

Advisory committees comprised of external advisers support the FDA’s mission of protecting and promoting the public health by providing us with independent advice on scientific, technical, and policy matters. The FDA makes the final decisions on any matters considered by an advisory committee.  

Committees are either mandated by statute or established at the FDA’s discretion. Advisory committees must meet the requirements set forth in the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). General procedures for FDA advisory committees are included in the FDA’s regulations at 21 CFR Part 14.  

The products the FDA regulates can impact the daily lives of the American public, and advisory committees are an important part of the FDA’s regulatory processes. While the Agency hears frequently from certain groups about advisory committees, we are interested in more broadly hearing from all parties interested in the advisory committee process and how advisory committees inform the FDA’s decisions. We are hosting this virtual public meeting to give an open and transparent platform for feedback on advisory committees. 

Commenting & Registration Deadlines

May 13, 2024, at 3 p.m.: Deadline to request to speak at the listening session. 

June 7, 2024:  Deadline for persons selected to speak at the listening session to submit all presentation materials, in PDF format, to ACFeedback@fda.hhs.gov. We ask that all presentation materials also be submitted to Docket No. FDA-2024-N-1809. 

June 13, 2024: Deadline to register to attend the listening session; registration may be performed at any time before or during the listening session. 

August 13, 2024: Deadline to submit written/electronic comments to Docket No. FDA-2024-N-1809. Additional information on commenting is available in the Federal Register notice. 

Topics  

To facilitate input, the FDA developed a series of topics covering the types of information that we are interested in obtaining:   

Topic 1: Composition of Advisory Committees 

  1. The membership of a committee, which is set by each committee's charter, typically varies depending on the focus of the committee and topics for particular meetings. In some cases, the composition of a particular committee may be set by law. To the extent there is flexibility in determining the composition of a committee or the expertise present at particular meetings: 
    • What are the categories of expertise, viewpoints, or voices that are particularly important for representation on advisory committees?  
    • What are the categories of expertise, viewpoints, or voices that may not be relevant given the topic or product type that is the focus of the committee?   
  2. Are there ways that FDA can better ensure that a variety of diverse perspectives and experiences are incorporated into advisory committee meetings, and if so, how? 
  3. In some cases, there is a legal requirement to include a consumer or patient representative on advisory committees. In other cases, the charter of an advisory committee may allow for there to be a consumer or patient representative who is a voting member of the committee. Consumers and patients may also participate in the open public hearing or submit written comments to the docket for a particular advisory committee meeting. Are there ways that FDA can better incorporate the consumer or patient voice into advisory committee meetings, and if so, how?  

Topic 2: Service on an Advisory Committee as a Special Government Employee (SGE) 

  1. Service on an advisory committee as an SGE gives individuals an opportunity to provide advice and recommendations on decisions that are often critical to protecting public health, but we understand that administrative burdens (e.g., amount of onboarding paperwork and processing time) are sometimes a deterrent to SGE service.  FDA is exploring ways to streamline the administrative requirements on SGEs for initial hiring and meeting preparation. While FDA must remain in compliance with federal laws around federal service, how might we mitigate administrative barriers to service for SGEs? 
  2. How can FDA otherwise improve the experience of advisory committee members? 

Topic 3: Public Perception and Understanding of Advisory Committees

  1. What do you perceive to be the public’s awareness and understanding of the role of FDA advisory committees? 
  2. What steps can FDA take to improve public awareness and understanding of advisory committees and their role in providing advice and recommendations for FDA to consider in its decision-making? 
  3. How can FDA better communicate with the public about advisory committee meetings? 
  4. FDA’s regulatory decisions are often, but not always, aligned with advisory committee recommendations. What steps can FDA take to clarify for the public that its regulatory decisions take the committee’s recommendation into account, but that the committee’s recommendations are only one of several factors considered? 
  5. There appears to be a persistent misconception that advisory committee votes are the final decision of the Agency on the matter considered by the committee.  Is there a way that FDA could adjust the processes for discussion and/or voting that would improve public understanding of how FDA receives external advice through the exchange of information at advisory committee meetings, and the ultimate import of the advisory committee’s discussion? 

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