FDA working to streamline adcomm system, hybrid model here to stay

The US Food and Drug Administration (FDA) is streamlining how experts participate on advisory committees and rethinking what topics the committees are asked to advise on, according to the agency’s top scientist.

During a webinar on 2 August hosted by the Alliance for a Stronger FDA, FDA Chief Scientist Namandjé Bumpus said her office is working on ways to improve its advisory committee system.

The role FDA’s advisory committees play in the review process has been a thorny topic in recent years, following the agency’s controversial decision to grant accelerated approval to Biogen’s Alzheimer’s disease drug Aduhelm (aducanumab) despite its Peripheral and Central Nervous System Drugs Advisory Committee voting overwhelmingly that they did not find the sponsor had provided primary evidence of effectiveness for the drug. (RELATED: FDA defends Aduhelm's accelerated approval, while others call for reform, Regulatory Focus 14 July 2021)

FDA Commissioner Robert Califf has said he wants to revamp the advisory committee system and has expressed that he doesn’t find advisory committee votes useful. Other top FDA officials have indicated they want advisory committees to continue to retain their voting capability. (RELATED: FDA’s Marks weighs in on adcomm reform, Regulatory Focus 21 July 2023)

Bumpus emphasized that while FDA values the advice of external experts on the panels, the decision to approve or reject a premarket submission is up to its own internal experts. She said she wants to optimize the advisory committee process to ensure FDA continues to get the expertise it needs from its committees. To that end, her office is working to figure out how to ensure they are identifying the right experts on any given topic and engaging with them in the most effective way.

“Part of that also is ensuring that those folks have a streamlined way to participate in advisory committees as far as ensuring that it's not cumbersome,” said Bumpus. “They're busy people, they've got many things that they're doing.”

Bumpus said that FDA is working to update the logistics behind onboarding panel experts so that the process is not as burdensome, the experts have all the information they need to understand their role on the advisory committee and ensure they stay engaged.

“A lot of the work is really inward looking at our processes, trying to see how we can make them the most effective and just relieve any type of extra effort that we might be asking for advisory committee members, at least from the logistical standpoint,” she added. “A lot of it is process work that we're doing, but we also are thinking through the types of topics that we utilize them for.”

Bumpus said she often thinks about how advisory committee experts can be used by FDA to get feedback on broader scientific topics, while noting that the agency already has a Science Board that advises the commissioner and other officials on complex scientific issues. However, she thinks there are questions, such as designing clinical studies, that experts can help the agency with.

“We're thinking through how we leverage [the experts], especially for some of these crosscutting scientific issues, thinking about how we utilize them for emerging science and understand where the emerging areas are,” she added.

On the issue of whether advisory committees should continue to vote on topics, Bumpus said her job is really focused on how to get expert information that can be used by FDA to make its decisions which ultimately lie in the hands of its review staff.

“Our decision-making really is made by career employees who are deep experts in these areas, who work in these areas and are focused on them and have a lot of understanding of needs and knowledge gaps and latest research, but certainly can always use interactions with experts to bolster that,” said Bumpus.

“I don't want to simplify it down to a conversation about voting or not,” she added. “I think it's really how do we leverage advisory committees more effectively? How do we really ensure that we're fully using them … That's really where my focus has been, and I think that we will be able to have some enhancements that we roll out in the future.”

During the COVID-19 pandemic, advisory committee meetings, like other meetings the agency organizes, were switched to a virtual format. Bumpus said these meetings will continue to use a hybrid model going forward. She noted that this allows experts who are not conveniently located, have conflicting availability and who have significant time constraints to participate in the meetings that typically take place in the DC, Maryland, and Virginia region.

Bumpus also said that the flexibility of hybrid or virtual meetings helps address issues of diversity, equity and inclusivity to open opportunities for people to participate in the discussions happening at FDA.

"There also is value obviously in in-person interactions as well, so we'll see different formats I think for different meetings,” she added. “It's really going to depend on the meeting and what works logistically.”

FDA working to streamline adcomm system, hybrid model here to stay

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