Managing Conflicts of Interest and Industry Influence in Government Advisory Committees: The Case of the FDA

• In Event: Conflicts of Interest and Professional Misconduct in Health Care

Abstract

The FDA frequently convenes advisory committees consisting of outside experts to offer guidance in the review of prescription drugs. There have been long-standing concerns that some of these experts have financial ties to pharmaceutical companies, leading to biased recommendations. Using 21 years of data on FDA drug advisory committee meetings, I examine whether the industry financial ties of  committee members are associated with biased voting. Using exogenous within-person variation in the scheduling of drug reviews relative to members’ industry relationships, I find that members who have ties to the drug sponsor are 15 percentage points more likely to vote in favor of the sponsor compared to members without any financial ties. In contrast, members with financial ties to competitor firms do not vote differently from those with no financial ties. This pro-sponsor bias is concentrated in votes on non-approval questions (e.g., post-market safety deliberations), rather than on drug approval questions.

I also examine the effect of changes in meeting-level conflicts of interest – specifically, the share of members with industry financial ties – on the probability that a majority (>50%) of members vote favorably for the sponsor. Using two novel instrumental variables, I find that increases in the share of members with ties to the sponsor lead to increases in the likelihood of favorable voting. By contrast, the share of members with ties to competitor firms has  no effect – positive or negative -- on voting in favor of the sponsor. Taken together, these findings suggest that management of conflicts of interest on advisory committees need not require banning all industry ties. Bias from conflicts of interest can be mitigated by reducing the participation of members with ties to the sponsor, while still allowing participation of members with ties to competitors, who can offer similar relevant expertise.

Author

• Genevieve P Kanter, University of Southern California
  Presenting Author