New Survey of 400+ FDA Advisory Committee Members Weigh in on Recommendations for Reforms

Respondents show strong alignment on key changes under consideration for FDA advisory committee meetings.

WASHINGTON, DC, August 13, 2024 – A survey reflecting the opinions of more than 400 current and former FDA advisory committee members about issues impacting FDA Advisory Committee meetings, was submitted to the FDA docket today. 3D Communications, a communications consultancy with clients who appear before FDA Advisory Committees, conducted the survey from July 11-23, 2024.   

The survey summarized 10 key recommendations generated from comments and suggestions of participants made during the FDA’s public meeting held on June 13, 2024, or that were posted to the public docket. The FDA described the meeting as a listening session “to solicit feedback on the Agency’s use of and processes for its advisory committee system.” Survey topics included: how to balance attracting additional subject matter experts (SMEs) and managing conflict-of-interest rules; issues regarding the practice of voting questions; and suggestions for how the FDA can better communicate with the public before and after the meetings.   

“We decided to conduct the survey following the mid-June FDA meeting because it was clear that advisory committee members’ voices were missing from the conversation,” said Jim DiBiasi, 3D Communications Co-Founder. “The FDA’s public listening session resulted in important recommendations. We felt it was essential for the advisory committee members to weigh in on those recommendations. We were thrilled with the robustness of the response to our survey, both in terms of the number of members responding and their comments.”  

Advisory Committee members showed strong agreement in many areas. Notable topline survey results including the following findings—    

Issues related to voting questions:  

• 95% agreed or strongly agreed that the FDA should continue to have a voting question on a product’s benefit/risk when deciding whether a product should be approved.   

• 86% agreed or strongly agreed that the FDA should present the proposed verbatim indication or intended use of products and ask advisors to vote on the appropriateness of that wording based on the available evidence.  

Issues related to the composition of advisory committee members, conflicts of interest and format of the meeting:  

• 84% agreed or strongly agreed that the FDA should include subject matter experts (SMEs) who are treating physicians with therapeutic expertise as voting members at advisory committee meetings.  

• 90% thought SMEs who had a conflict of interest should be allowed to participate in the meeting, although most said that those with conflicts, even if disclosed, should participate as a non-voting member. There were also many comments that participation should be decided on a case-by-case basis.  

• 48% agreed or strongly agreed that all advisory committees should have both a voting patient representative and a voting consumer representative; an additional 30% neither agreed or disagreed.   

• 72% agreed or strongly agreed that meetings should be modified to allow for adequate time for sponsors to comprehensively address all questions and concerns raised by committee members.  

Issues related to public communication about advisory committee meetings:

• 94% agreed or strongly agreed that the FDA should establish clear public communication procedures explaining their reasoning when they disagree with advisory committee votes.   

• 61% agreed or strongly agreed that the FDA should take more proactive steps to inform patients and consumers of advisory committee meetings and encourage participation during the public comment period.  

• 74% agreed or strongly agreed that the FDA should continue to allow remote participation at meetings, as it did when COVID 19 restrictions were in place, to increase public participation.  

• 74% agreed or strongly agreed that FDA should share the meeting materials earlier than two days before the meeting as is now done.  

Participants surveyed included those who served on advisory committees for drugs, biologics and medical devices. Specifically—

• 86% served as voting members;  

• 56% participated in one to three advisory committee meetings in the last three years; and 

• 21% having participated in four or more advisory committee meetings.    

Results did not vary materially when looking at responses by committee member experience.

To view full results of the survey with all comments, click here. Subgroup analyses is available upon request.

About 3D Communications

For more than 20 years, 3D has partnered with pharmaceutical, biotech, and medical device companies to prepare for high-stakes interactions and build the skills they need to communicate effectively. 3D’s science, communications, regulatory, and market access experts leverage their proven 3D ACT^® process and state-of-the-art technology to help clients transform complex information into clear and convincing messages and presentations—and deliver with confidence and purpose.