Project Grant 2214796

The National Bureau of Economic Research, Inc. (NBER) received a three-year, $441,000 Project Grant award from the National Science Foundation's (NSF) Social, Behavioral, and Economic Sciences program (CFDA 47.075) to evaluate decision-making by the U.S. Food and Drug Administration's (FDA) advisory committees. NBER will conduct three research papers analyzing how FDA advisory committees collect and use information to make recommendations on new drug, biological and medical device approvals. The first paper will use a game theory model and committee meeting transcripts to study how institutional changes could impact correct recommendation outcomes. The second will examine the effect of diversity representation mandates on deliberations. The third will assess long-term recommendation quality by comparing post-approval product performance to a counterfactual scenario. Insights from this research could inform FDA process improvements and apply to other regulatory and policymaking bodies. The grant was awarded on August 1, 2022 and is scheduled to be completed by July 31, 2025.