FDA officials argue for retaining advisory committee votes, welcome return to face-to-face meetings

WASHINGTON – Officials from the US Food and Drug Administration (FDA) argued that advisory committees should retain their voting procedures on whether to recommend drugs and said that such votes offer clarity on the committees’ deliberations.

Agency officials made these assertions at the 2024 Biopharma Congress meeting on 26 February. The officials also noted that there will be a return to face-to-face advisory committee meetings this fall. During the meeting, which was moderated by Kate Rawson of Prevision Policy, officials were asked to address a wide range of issues related to advisory committees, such as whether advisory committees should continue to vote on the safety and efficacy of products brought before the committees, the return of face-to-face meetings, and plans to retain the “point-counterpoint” discussion summarizing the reasons to approve or reject drugs under development.

Since last February, FDA Commissioner Robert Califf has expressed interest in reforming the advisory committee meeting structure to allow fuller and more comprehensive discussion of the issues surrounding medical products and has said that meetings should focus less on the voting outcomes. (RELATED: Califf: Advisory committee meeting structure needs an overhaul, Regulatory Focus 14 February 2023)

Yet other FDA officials disagreed with Califf’s views and said the voting system should be retained.

Peter Stein, director of FDA’s Office of New Drugs, stated that “the vote is important … the benefit of taking a vote is that if you say no, you have to explain why it’s no, and if you say yes, you have to explain why its yes.”

Richard Pazdur, director of the Oncology Center of Excellence (OCE) also expressed support for retaining the vote. He noted that companies tend to hear “what they want to hear” during meetings with the review team, but the vote is more final.

“People will hear what they want to hear [during review meetings]. When we come back after a vote, these drug companies turn into fire breathing dragons.… Its’s a very contentious thing. They are spending millions of dollars on a drug that will not be approved.”

He added that “at the end of the day, we have to have clarity on what was said at that meeting and that vote gives us clarity.”

FDA’s interest in reforming its advisory committee system was prompted from the recent decision to grant accelerated approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) in 2021, despite an advisory committee voting against its approval. In late January, Biogen announced it would discontinue Aduhelm sales to focus on its other Alzheimer’s treatment, Leqembi (lecanemab), and other newer candidates.

Return of in person meetings

Officials also welcomed the return of face-to-face advisory committee meetings. Stein said that in the current virtual era when “cameras are off” human interaction is missing. He added that “I’m hoping that by the fall, most of our meetings will be in person.”

Pazdur concurred, saying “the dynamics of a meeting is lost when people have their cameras turned off. There has to be more of a conversation.”

There was also some discussion on whether to retain the “Point-Counterpoint” section of the advisory committee meeting package. For this package, FDA prepares a list of reasons for either approving or rejecting the drug under consideration while the company prepares a document summarizing why the drug should be approved.

Pazdur said the document should be retained. He said that “advisory committee members really like” the document.

Yet Johns Hopkins University’s Caleb Alexander did not support the idea of having this document, saying it was too subjective. “I would advise against it.”

The panel’s moderator said that “in the case of Adulhem, it was a missed opportunity for FDA to explain. This was the only time a point/counterpoint was not used,” said Rawson.

BioPharma Congress

FDA officials argue for retaining advisory committee votes, welcome return to face-to-face meetings

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