Califf says major effort underway to reform advisory committee meetings

US Food and Drug Administration (FDA) Commissioner Robert Califf said that “systemic” efforts are underway to reform advisory committee meetings and reiterated his belief that it is not necessary to take a vote at most meetings. Yet the FDA chief offered few other details about the reforms at a 31 January seminar sponsored by the Alliance for a Stronger FDA.

Califf also asserted that there is a need for greater integration of real-world evidence (RWE) in the postmarketing space to plug in some of the data holes for drugs with accelerated approval.

Since last February, Califf has been saying the advisory committee meeting structure needs to be changed to allow fuller and more comprehensive discussion of the issues surrounding medical products under review and that meetings should focus less on the outcomes. (RELATED: Califf: Advisory committee meeting structure needs an overhaul, Regulatory Focus 14 February 2023).

One of the factors prompting these calls for reform was FDA’s accelerated approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), despite an advisory committee vote against recommending the drug for approval. This week, Biogen announced it would discontinue Aduhelm sales to focus on its other Alzheimer’s treatment, Leqembi (lecanemab), and other newer candidates.

When asked to address the progress of these reforms, Califf said “we’ve done a lot of work on advisory committees behind the scenes and have worked with the centers who each have had their own systems for advisory committees. If you look at it right now, you’ll see that the system is working better and we’re getting better experts. This is complicated because of a conflict of interest and navigating, and getting the right people who actually know the field and can help the FDA with good advice.”

He added that “I think this issue of whether to take a vote or not, the discussion of it has sharpened the way the meetings are held. By the way, I still believe we don’t have to take a vote at most meetings. There are some where a vote is crucial and helpful. But we have some systemic efforts that I can’t talk about yet because we are trying to reach an agreement internally on what we might do.”

Califf also discussed the need for RWE in the postmarket space, especially to for drugs with accelerated approval.

“In the postmarket space, there is no one in that space in term of the standards, we have so many questions that do not get answers that are critical to public health and critical for ongoing safety. The more accelerated approvals we have the more we need post market data that is reliable.”

On the premarket side, Califf said “our contention is that premarket drug and device development, it is not as perfect it can be, and a lot of things can be better. But it is a space where we can work more efficiently.”

Califf said that other priorities are fighting misinformation related to vaccines. “I still don’t think that we are winning the misinformation battle.”

He was also asked to address how FDA addressing ongoing uncertainty related to FY 2024 funding, and the fact that the continuing resolution extends through 1 March. He said that “we have veteran staff at FDA who have been through this before … it has almost become an expectation that we wind up in this situation.”

Another priority is to address knowledge gaps in understanding how medications affect pregnant people. He said that fear of liability prevents many companies from enrolling pregnant patients in clinical studies.

Califf said he has a daughter who was born with congenital heart disease, and that when she was pregnant it was difficult to get information on drug interactions. He added that using artificial intelligence such the use of digital twins, would help to fill in these knowledge gaps.

Califf says major effort underway to reform advisory committee meetings

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