Today, the U.S. Food and Drug Administration announced it will host a listening session in June as part of its broader work to optimize the use of, and processes for, advisory committees. This virtual public meeting will focus on the composition of advisory committees, ways to improve the experience for members serving on committees and ways to ensure public awareness and understanding of the role of FDA advisory committees.

Advisory committees are typically made up of technical, scientific, public health and medical experts, as well as representatives of industry, consumer organizations and patients. They provide the FDA with independent advice on many topics, including the development, use and evaluation of drugs, biological products, medical devices and tobacco products, as well as broader scientific, medical and public health topics. Advisory committees provide non-binding recommendations to the agency, and final decisions are made by the FDA.

“The FDA regulates products that impact the everyday lives of the American people, and advisory committees play a key role in that process. It’s important we have the right expertise, diverse viewpoints and other processes in place to ensure the agency gets timely and sound advice,” said FDA Commissioner Robert M. Califf, M.D. “We are hopeful this listening session will provide valuable feedback on optimizing the advisory committees’ role in the agency’s science-based decisions and its mission in protecting and promoting public health.”

For the listening session, the agency is seeking input on whether there are ways the FDA can better incorporate a variety of diverse perspectives and experiences, as well as consumer and patient voices into advisory committee meetings. The FDA also wants feedback on how it could streamline any administrative burdens (e.g., the amount of onboarding paperwork and processing time) that may make it less likely for an individual to want to serve on a committee. Additionally, the agency is interested in hearing about how it could improve the public’s awareness and understanding of the role of FDA advisory committees. For example, the FDA is seeking input on if it could update any processes on advisory committee discussion and/or voting that would clarify any misconception that advisory committee votes are binding on the agency’s final decision rather than recommendations that are only one of several factors considered in the FDA’s decisions.

“Although all decisions are made by FDA staff, the discussions that take place at advisory committee meetings are important pieces that are considered as part of the FDA’s decision-making,” said FDA Principal Deputy Commissioner Namandjé Bumpus, Ph.D. “Gathering broad feedback on the advisory committee process and how these committees inform agency decisions in an open and transparent platform will inform our work to further enhance how the FDA uses the input of our external experts.”

The FDA is currently considering how advisory committee policies and practices can be optimized. These efforts include: (1) initiatives to modernize systems to reduce paperwork burden and streamline processes; (2) exploring ways to improve the utility of advice received from advisory committees; (3) considering ways to amplify recruitment of potential committee members, possibly through increasing dedicated staff and engaging existing committee members; (4) establishing mechanisms to share and standardize certain practices and procedures across the agency; and (5) working to improve public understanding of advisory committees and the roles they play. Although some of these potential initiatives are geared toward internal processes, the FDA expects to engage the public and committee members through the course of these efforts when appropriate, including through the public listening session.

The agency will hold the virtual listening session on June 13 from 9 a.m. to 4 p.m. ET. To register for the free public meeting, please visit the FDA’s website. Input from the public may be provided orally or written; however, in all cases, the FDA encourages participants to provide the specific rationale and basis for their comments, including any available supporting data and information. Those interested in making an oral presentation at this public meeting must register by 3 p.m. ET on May 13. The FDA is establishing a public docket for this listening session. Electronic comments must be submitted to the https://www.regulations.gov electronic filing system on or before August 13, 2024. Registration to speak at the meeting is based on space availability, with priority given to early registrants. Information on requests for special accommodations due to a disability will be provided during registration.

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