FDA Advisory Committee and Conflicts of Interest

The Searle Civil Justice Institute has commissioned a task force of legal and economic scholars to examine the Food and Drug Administration’s use of advisory committees (ACs) to determine the extent to which committee members’ financial interests affect their voting behavior.

The FDA’s drug approval determinations are made by advisory committees comprised of a limited pool of technical experts from industry, academia and consumer groups. Often these experts have various financial interests tied to industry participants that raise potential conflicts with regard to their voting behavior. However, the actual existence, scope and direction of potential biases are largely based on conjecture.

This initiative is the largest empirical project that attempts to comprehensively determine the existence of voting bias among the independent experts that serve on FDA advisory committees and to provide a statistical analysis of the direction and extent of biases that are identified.

This large-scale, data-driven project will be conducted in two phases.  In the first phase of the report, the report found that there were no statistically significant relationships between the presence of a conflict and the odds of voting for drug approval.

The second phase of the report makes a more rigorous argument.  Utilizing an event study, the second phase of the report looks to see if there are any statistically significant changes in the stock prices of companies after an advisory committee makes a decision on a drug.

Members of the task force include:

  • Joseph Golec, Professor of Finance, University of Connecticut School of Business
  • James C. Cooper, Director, Research & Policy, Law & Economics Center and Lecturer in Law, George Mason University School of Law

FDA Advisory Committees: An Empirical Examination of Conflicts of Interest (2013)

FDA Advisory Committees: Conflicts of Interest and Voting Relative to Benchmarks (2015)