FDA Advisory Committees: The Importance of Meeting

Food and Drug Administration (FDA) advisory committees are often a key component of the process the agency uses to evaluate drugs, devices and other medical products, as discussed previously in Worst Pills, Best Pills News.[1] Public Citizen frequently participates in these advisory committees and testifies during the open public hearing that is part of each meeting.

In 2024, under the Biden Administration, the main policy issue for FDA advisory committees was voting questions and whether the agency would maintain, expand or de-emphasize voting.[2] In 2025, under the Trump Administration, the main policy issue is how frequently FDA advisory committees will meet, or whether they will even meet at all.

In 2024 the FDA convened 38 meetings of its advisory committees. From January to November 6, 2025, the agency convened only 11 meetings and had scheduled two meetings for later in the year.[3] The FDA has more than 30 advisory committees; one committee, the Medical Devices Advisory Committee, has 18 panels.[4]

Federal advisory committees meet in public, follow rigorous administrative procedures under the Federal Advisory Committee Act and, as their name implies, are advisory. Typically the members of FDA advisory committees are independent experts on scientific, technical and policy issues. The committees’ recommendations are nonbinding; the FDA regularly follows their recommendations but is not legally required to do so. For years the agency has generally posed written questions to its advisory committees, some of which are for discussion and at least one of which is for a vote.[5]

Two recent developments are particularly concerning. First, FDA Commissioner Martin Makary has convened “expert panels” as an alternative to advisory committees, on such topics as selective serotonin reuptake inhibitors and pregnancy, menopause and hormone replacement therapy for women, and food allergies.[6] The panels are touted as “independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action.”[7]

In fact, panel members are handpicked by FDA leadership with insufficient attention to conflicts of interest and to ensuring a broad range of scientific expertise.[8] The panels bypass the rigorous advisory committee process and limit the participation of FDA scientists and the public. The FDA can use the panels to advance preconceived agendas, such as removing the boxed safety warnings on menopause hormone therapy products.[9] Panel members with conflicts of interest may stand to gain financially from the recommendations they discuss.[10]

Second, George Tidmarsh, who was until recently the director of the FDA’s Center for Drug Evaluation and Research, has reportedly said the agency “‘would like to get away’ from assembling panels of experts to examine and vote on individual drugs, because ‘I don’t think they’re needed.’” Tidmarsh reportedly said that advisory meetings on specific drugs were “redundant” and “a tremendous amount of work for the company and for the FDA. We want to use that work and our time to focus on the big questions.”[11]

Although the FDA’s recent decision to publish complete response letters about drugs the agency has rejected is an important step forward,[12] releasing the letters does not make advisory committees redundant. The letters reflect the FDA’s thinking. Advisory committee discussion of individual drugs reflects the thinking of outside experts and provides the agency with indispensable input before reaching a final decision. The meetings strengthen public understanding and the FDA’s credibility.

De-emphasizing votes by FDA advisory committees and now de-emphasizing the meetings themselves are bad ideas. The FDA should reconsider, and soon.
 

References

[1] Steinbrook R. FDA advisory committees: the importance of voting. Worst Pills, Best Pills News. 30(8): August 2024.

[2] Ibid.

[3] Food and Drug Administration. Advisory Committee Calendar. https://www.fda.gov/advisory-committees/advisory-committee-calendar. Accessed September 29, 2025.

[4] FDA Advisory Committees and Meeting Materials. https://www.fda.gov/advisory-committees/committees-and-meeting-materials. Accessed September 29, 2025.

[5] Steinbrook R. FDA advisory committees: the importance of voting. Worst Pills, Best Pills News. 30(8): August 2024.

[6] FDA expert panels. https://www.fda.gov/patients/fda-expert-panels.  Accessed September 22, 2025.

[7] Ibid.

[8] Robertson R. FDA ‘expert panels’ raise concerns of evading regulations, ethics. MedPage Today, July 24, 2025. https://www.medpagetoday.com/washington-watch/fdageneral/116662. Accessed September 29, 2025.

[9] Riddle K. Doctors urge FDA to remove black box warning on hormone replacement therapy for menopause. NPR Shots-Health News. https://www.npr.org/sections/shots-health-news/2025/07/25/nx-s1-5477644/menopause-hormone-therapy-fda-health. Accessed September 29, 2025.

[10] Rabin RC. F.D.A. panelists call for removal of warnings on menopause treatments. New York Times. July 19, 2025. https://www.nytimes.com/2025/07/17/health/hormone-therapy-menopause-fda.html. Accessed September 29, 2025.

[11] Allen A. Under Trump, FDA seeks to abandon expert reviews of new drugs. KFF Health News. September 12, 2025. https://kffhealthnews.org/news/article/fda-advisory-committee-meetings-response-letters-makary-transparency-drugs/. Accessed September 29, 2025.

[12] Steinbrook R. Improved public information about FDA rejection letters. Worst Pills, Best Pills News. November 2025.