Zachary Brennan, Endpoints News, July 7, 2023
As the FDA explores how to reform its advisory committees in ways to ensure the agency receives more timely and sound advice — a process the agency acknowledges is ongoing and not easy — new research points to a decline in adcomms in recent years, and an FDA commissioner who has insisted there may be fewer votes at future meetings, too.
From 2010 to 2021, the FDA held 409 adcomms related to human drugs, but the meetings were convened “less frequently over time, from a high of 50 in 2012 to a low of 18 in 2020 and 2021,” researchers from Harvard’s Program on Regulation, Therapeutics, and Law (PORTAL) wrote in JAMA Health Forum today. “Much of this decrease occurred at committee meetings involving votes on initial approvals, which declined from a high of 26 in 2012 to a low of 8 in 2021.”
Adcomms in general have become slightly less controversial than the fever pitch of critiques the agency faced after several members of the adcomm that voted unanimously against Biogen’s Alzheimer’s drug Aduhelm (aducanumab) resigned in protest of its accelerated approval.
The adcomm that recently reviewed Aduhelm’s successor, Leqembi, which won a full approval yesterday, sailed through with a unanimous vote, but with just six voting members on the committee, and not without controversy.
The FDA had sought but then reversed course at the last minute on adding David Weisman, a neurologist with Pennsylvania-based Abington Neurological Associates who worked on clinical trials for Eisai and Biogen, for the Leqembi (lecanemab) adcomm meeting. Weisman had received tens of thousands of dollars from Eisai and partner Biogen over the last five years, and been vocal about his support for lecanemab, making his impartiality a question mark.
“The fact that FDA and Dr. Weisman apparently consider this a ‘potential’ conflict of interest, rather than an obviously outrageous conflict of interest, tells us that FDA needs to hire some bioethicists to help them vet Advisory Committee members,” Diana Zuckerman, president of the National Center for Health Research, said via email.
But dismissing industry favoritism with its adcomm process may be a tall task for FDA as so far this year, 18 of 19 drug-related adcomms have ended with a positive result for industry.
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