Is Now the Time to Reshape the FDA’s Advisory Committees?

The federal advisory committees that provide recommendations to the Food and Drug Administration ( FDA ) are essential in the agency's mission for protecting public health. The external experts that make up these committees help evaluate evidence that inform whether or not a new drug or device should be approved for use with patients.?

The agency isn’t required to agree with the advisory committee’s ruling. However, the FDA’s decision in 2021 to authorize an Alzheimer’s drug despite recommendations against approval from the advisory committee drew national headlines.

Instances like this have led both policymakers and the public to question how the agency is using its advisory committees and whether those committees are functioning as well as they could.?

Arnold Ventures supports research and policy development aimed at strengthening the FDA advisory committee process, including more transparency into financial conflicts of interest among committee members, the frequency and timing of committee meetings, and with what regularity the agency’s decisions are out of alignment with those of the advisory committee.

Last month we convened a panel of experts?including Genevieve Kanter PhD, from the 美国南加州大学 ; Sean Tunis , MD, MSc, former FDA and Centers for Medicare & Medicaid Services official; and @Joseph Daval, JD, former fellow at the Program on Regulation, Therapeutics, and Law (PORTAL) at Harvard University.? The discussion, part of ISPOR 2024?in Atlanta, GA, focused on topics including the role of expert advice in government decision-making, historical and emerging concerns about FDA advisory committees, and ways to improve the process.

Now, the FDA has announced a public virtual listening session?on June 13, 2024 to solicit feedback on their use of and processes for its advisory committee system. We are encouraged by this news and hope the listening session will aid in the optimizing the advisory committee’s role in the FDA’s science-based decisions.

For more information or to participate: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/public-meeting-optimizing-fdas-use-and-processes-advisory-committees-06132024?

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Written by: Erin Jones

Health Care Manager, Drug Pricing at Arnold Ventures