Daniel G. Aaron (University of Utah, S.J. Quinney College of Law) and Grant Boyden (Spencer Fane) have posted Reimagining FDA’s Corporate Funding: Pathways to Reform or Abolition of User Fees on SSRN. Here is the abstract:
The U.S. Food and Drug Administration derives most of its drug regulatory budget from “user fees” paid by pharmaceutical companies. This White Paper lays out a foundation to understand drug user fees, assesses the controversies surrounding them, and offers a menu of ways to reform or abolish them to protect public health, ensure regulatory integrity, promote public trust, and encourage innovation. Ideas were drawn in part from a June 9, 2026 workshop held at the Boston University School of Law, entitled Reimagining FDA Funding in a Post-PDUFA World.
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Lawrence Solum