User Fees and the Food and Drug Administration: Deliberation, Transparency, and Public Trust

This project aims to critically examine the development of user fee legislation for the U.S. Food and Drug Administration (FDA) through the reauthorization of the Prescription Drug User Fee Act (PDUFA). Through document analysis and key informant interviews, Prof. Schwartz and colleagues will seek to examine ethical issues related to deliberation, public participation, and transparency in the PDUFA reauthorization process and its outcomes. The team aims to develop recommendations for how FDA and Congress can undertake this work in ways that enhance trust in FDA and advance its critical work promoting public health and the public good.