FDA Policy/General

Study Finds Public Speaker Conflicts at FDA Panel Meetings

A new analysis of nearly a decade of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval — and many have financial conflicts of interest (COI), according to research published in JAMA Internal Medicine.

Researchers from Mass General Brigham examined transcripts from 161 FDA human-drug advisory committee meetings held between 2015 and 2023, involving 1,481 public testimonies from 1,217 unique individuals. Their analysis shows:

82% of speakers voiced support for drug approval.
43% of speakers disclosed a conflict of interest (COI), most commonly that they or their organization received financial support from a drug manufacturer.
Speakers with a disclosed COI were 11% more likely to back approval than those without reported ties.

The study also broke down speaker roles: nearly half (48%) were patients or family members with personal experience using the drug under discussion; clinicians made up 21%, unaffiliated public health advocates 13%, and patient-advocacy group representatives 10%.

Lead author Leah Z. Rand argued that while patient voices are essential, the study highlights a need for broader diversity of perspectives and stronger transparency around financial ties. The authors recommend mandatory COI disclosures and independent verification of those ties, for example via public reporting platforms. Notably, the authors did not study whether public comments actually sway FDA decisions.

This research adds to longstanding concerns over bias in public engagement at FDA advisory meetings. Previous studies have also flagged undisclosed financial associations among speakers.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome