Conflicts of Interest in FDA Advisory Committees: A Systematic Literature Review.

OBJECTIVES To systematically review empirical evidence on the prevalence and influence of conflicts of interest (COIs) among members and public speakers of US Food and Drug Administration (FDA) advisory committees.

METHODS Following PRISMA guidelines, we searched MEDLINE, PubMed, and Cochrane Library from inception to November 2024 for peer-reviewed studies reporting quantitative data on COIs in FDA advisory committees. Eligible studies examined prevalence, type, or impact of COIs among voting members or public speakers. Data extraction and quality assessment were conducted independently by two reviewers using the Joanna Briggs Institute checklist for cross-sectional studies.

RESULTS Eighteen studies published between 2006 and 2022 were included, covering committee activity from 1997 to 2022. COIs among voting members ranged from 15% to over 70% of meetings, while 25% of public speakers disclosed financial COIs, most commonly consulting fees, research funding, and stock ownership. Evidence linking member COIs to voting outcomes was mixed, with some studies finding no significant association. In contrast, public speakers with financial COIs were consistently more likely to deliver favorable testimony, with odds ratios ranging from 3.0 to 6.1. Several studies suggested a decline in member COI prevalence after the 2007 FDA Amendments Act, but no similar trend was observed among public speakers.

CONCLUSIONS COIs remain prevalent in FDA advisory committees, particularly among public speakers, where they are strongly associated with favorable testimony. These findings underscore the need for stronger and more consistent COI disclosure and management policies that include both committee members and public speakers to protect decision-making integrity.