FDA Plans Major Reforms to Advisory Committee Process, Aiming for Enhanced Expert Involvement
January 31, 2024
The FDA is planning significant reforms to its advisory committee process, as announced by Commissioner Rob Califf. While specifics are scarce, these changes are spearheaded by Namandjé Bumpus, the FDA’s chief scientist, and newly appointed deputy commissioner.
Califf noted improvements in the current advisory committees, mentioning better expertise and a more focused discussion. He believes that votes are only sometimes necessary in committee meetings, though they can be crucial in certain situations. This view aligns with previous comments where he questioned the need for votes by external advisors on drug approvals.
Janet Woodcock, the outgoing principal deputy commissioner, preferred advisory committees (adcomms) to be more involved in the development process. She criticized the current “courtroom-style drama” of up-or-down votes on drug approvals, suggesting that adcomms should contribute earlier on aspects like study endpoints and protocol designs.
In 2024, the FDA has been more deliberate in scheduling meetings for individual products. The tone of these meetings has shifted, becoming less contentious compared to past high-profile cases. Notably, most drug-related advisory committee meetings in the previous year concluded with favorable outcomes for the pharmaceutical industry.
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[Source: Endpoints, January 31st, 2024]
