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 uses independent expert advice to help determine whether it should approve new drugs. Because of the technical nature of the products, ACs are generally comprised of consumer and patient representatives as well as scientists with highly specialized skills and experience. Due to the limited pool of scientific experts, advisory committee members may also have financial interests in the industry. Commentators have expressed concern that financial interests will result in biased votes. However, the existence, scope, and direction of potential biases have largely been the subject of conjecture.
The Searle Civil Justice Institute has undertaken a large scale, empirical project to study the potential for bias in the AC voting process. If biases do indeed exist, the SCJI will further determine whether they are statistically significant and whether they are positive or negative; that is if biases result in drugs reaching consumers that otherwise would not, or if these biases prevent otherwise safe drugs from entering the market. These findings will add substance to the debate and will inform policymakers as to the actual effect that conflicts of interest in advisory committee voting has on consumers.
The Searle Civil Justice Institute Task Force on FDA Advisory Committee Conflicts of Interest will produce a comprehensive, peer-reviewed Policy Report in 2012. Members of the task force include:
- Joseph Golec, Associate Professor, University of Connecticut
- John Vernon, Assistant Professor, University of North Carolina
For additional information regarding the Searle Civil Justice Institute or the Task Force on FDA Advisory Committee Conflicts of Interest please call 703-993-8040.