Date of Award
January 2025
Document Type
Open Access Thesis
Degree Name
Master of Public Health (MPH)
Department
School of Public Health
First Advisor
Jason Schwartz
Abstract
The Prescription Drug User Fee Act (PDUFA) has had a critical role in funding the Food and Drug Administration (FDA) through the form of industry user fees since 1992 with user fees comprising 48% of the FDA’s Fiscal Year 2024 budget. As the FDA faced pressure from Congress and the pharmaceutical industry to reduce drug application review times, the legislation was enacted to provide a funding source in addition to Congressional appropriations so the agency could meet proposed review time goals. As the FDA began to hire additional review staff, reduce application review times, and increase the number of pharmaceuticals approved, PDUFA was reauthorized in 1997, and Congress continues to reauthorize the legislation every five-years based on a sunset provision clause. PDUFA has significantly evolved since its original enactment, with each cycle detailing specific goals for the FDA and purposes for which user fees will serve in the agency’s regulatory activities. Analyses of each PDUFA cycle will outline the evolution of user fees, the rationale for the legislation, and challenges associated with funding the FDA in this capacity. History of the concept of user fees and the passage of the legislation will be examined. The performance goals, expectations, and legislative procedures of the FDA for each PDUFA cycle will be analyzed. Policy concerns and recommendations associated with user fees will be provided. With the PDUFA VII cycle concluding in 2027, the subject of user fees will be debated again by the FDA, industry, and Congress in the forthcoming years. Policy implications include increasing transparency in the PDUFA negotiation process, increasing the number of outside stakeholders involved in discussions, and ensuring that added pressure to increase review times does not alter the FDA’s mission and purpose. Examining the enactment and evolution of PDUFA through the various reauthorization cycles highlights policy issues that have arisen from industry user fees and can help inform policy efforts to shape future reauthorization cycles.
Recommended Citation
Ziaks, Therese, "The Prescription Drug User Fee Act (pdufa): The Design, Evolution, And Challenges Of User Fees And The Reauthorization Process" (2025). Public Health Theses. 2577.
https://elischolar.library.yale.edu/ysphtdl/2577
This Article is Open Access
Comments
This is an Open Access Thesis.