The FDA on Thursday heard feedback from a slew of stakeholders on potential upcoming changes to the advisory committee process — and the reviews were mixed.
The meeting was held to glean public input on the composition of advisory committees, committee members’ roles as special government employees and how the agency should handle votes.
The FDA has floated changes to the process that could include fewer votes, though they likely won’t be completely removed. Officials are also considering increasing the number of in-person meetings and issuing joint FDA-industry briefing documents ahead of meetings.
FDA Commissioner Robert Califf said at the meeting the FDA is looking for ways to better communicate the role of advisory committees to the public.
“I also hope that disagreements in interpretation between our staff and advisors should not always be regarded as a negative,” he said. “If we always agreed, we wouldn’t need advice.”
Reshma Ramachandran, a professor of medicine at Yale University and the chair of the Doctors for America FDA task force, said that holding votes during advisory committee meetings helps bolster public trust. She said the FDA is typically making binary decisions when reviewing product applications or deciding on new regulatory standards.
“Convening outside, independent experts and asking them to vote on these issues and make a similar binary decision reflects their best judgment in the evidence available,” she said.
Several presenters at the meeting spoke about conflict of interest rules on advisory committees, which prevent some experts from serving on the panels if they work in the specific area in question.
Steven Berman, deputy vice president of science and regulatory affairs at BIO, said the FDA needs to loosen its conflict of interest rules surrounding advisory committees to bolster expertise.
“Consequently, FDA advisory committee members may lack the necessary experience or expertise to effectively advise the agency on matters such as the safety, efficacy and benefit risk assessment of investigational medicines,” Berman said.
Aaron Kesselheim, a professor of medicine at Harvard University who in 2021 publicly left an advisory committee after Biogen’s Alzheimer’s drug Aduhelm won approval, has a different view. He said that the agency should more closely screen for conflicts of interest and that he’s confident the agency can tap enough experts that don’t have a conflict.
He added that the FDA should consider cutting down the time for industry to make presentations and instead allow for more discussion time during the meetings.
“Similarly, the experience of being an advisory committee member would be enhanced with guidance about how to consider the sometimes hours of personal, individual testimony provided by patients,” he said. “It’s hard to know how to take those personal statements and weigh them against the clinical trial data that the advisory committee has been organized to assess.”