Most public speakers at FDA advisory committees support drug approval

U.S. Food and Drug Administration (FDA) advisory committees play a key role in evaluating the efficacy and safety of new drugs. They include open public hearing sessions, whereby patients, clinicians, and advocates share input. To assess the experiences and perspectives of public speakers, Mass General Brigham researchers reviewed minutes and transcripts from 161 FDA Human Drug Advisory Committee meetings held from 2015 to 2023 and found that most public speakers support drug approval - especially patients or family members with personal experience using the drug and those who reported conflicts of interest (COI). Findings are published in JAMA Internal Medicine.

The study found 96% of meetings included public speakers. When assessing the 1,481 testimonies from 1,217 unique individuals, researchers discovered patients and family members accounted for the highest percentage of speaker testimonies (48%), followed by clinicians (21%), public health advocates who didn't come from organizations that represented specific diseases (13%), and patient advocates (10%).

Overall, 82% of the speakers supported drug approval and 43% disclosed a COI, typically that they or the organization they represent have received financial support from a drug manufacturer. The authors note COI reporting is not mandatory and this number may be an underrepresentation. Speakers with a COI were 11% more likely to support the drug than those who did not report a COI. For most speaker types, the majority supported approval; the lone exception was that 72% of testimonies by public health advocates did not support drug approval. Support was highest among patients and family members with personal experience using the drug – often through clinical trials. Of this group, 99% supported approval.

"The voices of patients and advocates are vital, but to ensure more balanced input, the FDA should seek contributions from a broader range of perspectives and strengthen efforts to monitor and mitigate conflicts of interest among public participants ," said lead author Leah Rand, DPhil, a research scientist in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Mass General Brigham Department of Medicine.

The authors recommended more robust transparency measures, such as mandatory COI disclosures and methods to independently assess potential conflicts, such as through Open Payments platform for clinicians or organizations' tax filings. They also called on the FDA to consider strategies to solicit input from a broader array of stakeholders.

The study was not designed to determine the degree to which public comments influence committee votes or FDA decisions.