FDA Advisory Committees: the Importance of Voting

The independent expert advice on scientific, technical and policy issues provided by advisory committees in public meetings is one of the great strengths of the process by which the Food and Drug Administration (FDA) evaluates drugs, devices and other medical products. Advisory committees, as the name implies, are advisory. The committees make nonbinding recommendations; the agency generally follows the recommendations but is not legally bound to do so. Typically, the agency poses written questions to the advisory committee, some of which are for discussion and at least one of which is for a vote.

In June 2024, the FDA held a “listening session” on improving the agency’s “use of and processes for advisory committees.” It will also accept electronic or written comments until Aug. 13, 2024.[1]

Because Public Citizen frequently participates in these advisory committees and testifies during the open public hearing sessions, we share the agency’s goal of improving the public perception and understanding of these meetings.

At the listening session, I emphasized the importance of maintaining or perhaps even expanding voting questions.[2]

Comments from Robert M. Califf, M.D., the FDA commissioner, had raised concerns that advisory committees will be asked to vote less frequently on central questions, such as whether a drug is effective for the treatment of a disease, whether the benefits of a drug outweigh its risks and whether the drug should be approved. In February 2023, Califf said the following at an industry meeting: “The purpose of the advisory committee is not to produce gladiator votes, so people say the FDA does not agree with its advisory committees. The purpose is to get advice, and the best advice is not whether this drug should be approved. That decision should be made by full-time civil servants.”[3] In May 2024, Califf made a similar comment at a Senate hearing.[4]

Voting is an integral part of the approval process because it allows committee members to record their overall view after a long and detailed discussion of the pluses and minuses of a drug or device. Importantly, without a vote, it would be easier for the FDA or the sponsor of a marketing application to spin the discussion as they wish and to disregard the committee’s advice. Moreover, a vote, particularly in instances when the FDA does not follow the committee’s recommendations, increases the chances that the agency will clearly and publicly state why it reached a different decision.

De-emphasizing votes by FDA advisory committees is a bad idea. As the saying goes, “if it ain’t broke, don’t fix it.” The FDA should recognize the importance of voting questions and leave them alone.
 

References

[1] Food and Drug Administration. Listening session: optimizing the Food and Drug Administration’s use of and processes for advisory committees; public meeting; request for comments. April 30, 2024. https://www.federalregister.gov/documents/2024/04/30/2024-09014/listening-session-optimizing-the-food-and-drug-administrations-use-of-and-processes-for-advisory. Accessed June 21, 2024.

[2] Steinbrook R. Comments at the FDA’s public meeting: optimizing FDA’s use of and processes for advisory committee meetings. June 13, 2024. https://www.citizen.org/article/comments-at-the-fdas-public-meeting-optimizing-fdas-use-of-and-processes-for-advisory-committees/. Accessed June 21, 2024.

[3] Eglovitch JS. Califf: Advisory committee meeting structure needs an overhaul. Regulatory News. February 14, 2024. https://www.raps.org/News-and-Articles/News-Articles/2023/2/Califf-Advisory-committee-meeting-structure-needs. Accessed June 21, 2024.

[4] Eglovitch JS. Califf grilled on avian flu, drug shortages, and adcomms during senate appropriations hearing. Regulatory News. May 8, 2024. https://www.raps.org/news-and-articles/news-articles/2024/5/califf-grilled-on-avian-flu,-drug-shortages,-and-a Accessed June 21, 2024.