2025 Spring Seminar Series Seminar: Genevieve Kanter University of Southern California

Industry Influence in FDA Advisory Committees

Abstract: The FDA frequently convenes advisory committees consisting of outside experts to offer guidance in the review of drug products. There have been long-standing concerns that some of these experts have financial ties to pharmaceutical companies, leading to biased recommendations. Using 20 years of data on FDA advisory committee members and several quasi-experimental strategies, I examine whether the industry financial ties of members are associated with biased voting. I find that members who have financial ties to the firm sponsoring the drug under review are more likely to vote in ways favorable to that firm. This biased voting is not observed in drug approval meetings but is seen in post-marketing evaluation meetings (i.e., for drugs already on the market that are re-evaluated). In addition, only some types of financial ties are associated with bias. These findings can guide policy makers in developing effective targeted reforms to address conflicts of interest in FDA advisory committees.