Changes to the FDA Advisory Committee process

It appears changes are coming to the FDA Advisory Committee process for evaluating new drugs.

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.

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