A majority of former and current FDA advisory committee members surveyed in July supported remote participation in meetings and better communication, as the FDA considers reforms to its committees of outside experts.
More than 400 past and present committee members weighed in on key topics raised during a public FDA meeting in June on “optimizing” the use and process of its advisory committees. The survey was conducted by 3D Communications, a consultancy that works with companies participating in advisory committees.
While FDA Commissioner Robert Califf has previously questioned the necessity of committee votes, 95% of survey respondents agreed or strongly agreed that the agency should continue to have a voting question on benefit and risk. Top FDA officials suggested in February that changes to the advisory committee process won’t completely eliminate votes.
When it comes to the composition of advisory committees, 90% of respondents said the FDA should allow subject matter experts with a conflict of interest to participate. However, most said participants with conflicts should do so as a non-voting member.
“Especially when it comes down to the area of orphan diseases or rare diseases, it’s often hard to find experts who aren’t conflicted,” 3D Communications co-founder Jim DiBiasi told Endpoints News on Tuesday. “There may only be a handful of treating physicians in the country, and those physicians are normally involved in the clinical trials.”
A majority of respondents (74%) also agreed that the FDA should continue to allow remote participation at meetings, following agency proposals to return to in-person meetings.
Peter SteinPeter Stein, director of the FDA’s Office of New Drugs, said at an event in February that FDA wants to increase the number of experts who can participate in meetings.
Respondents also weighed in on rare circumstances when the FDA doesn’t agree with an advisory committee’s recommendations. A total of 94% said the FDA should establish “clear public communication procedures explaining their reasoning” when they disagree with committee votes.
The FDA aligned with 88% of 409 advisory committee votes between 2010 and 2021, according to a study conducted by Harvard’s Aaron Kesselheim and his team. Kesselheim publicly left an advisory committee in 2021 after Biogen’s Alzheimer’s drug Aduhelm won approval against the recommendation of committee members.
Califf has previously said the FDA is looking for ways to better communicate the role of advisory committees to the public, stressing that the committee’s purpose is to give advice.
“I also hope that disagreements in interpretation between our staff and advisors should not always be regarded as a negative,” he said at a June meeting. “If we always agreed, we wouldn’t need advice.”
A majority of respondents also called for FDA to take “more proactive steps to inform patients and consumers of advisory committee meetings and encourage participation during the public comment period.” Seventy-four percent said the agency should share public meeting materials earlier than two days before the meeting occurs.
The FDA told Endpoints on Tuesday that it relies on “many advisory committees to help us make sound decisions based on the best science available.”
“FDA advisory committees give our own agency experts outside, independent, and professional advice on various complex scientific, technical, and policy issues,” an agency spokesperson said in an email.