Wedoany.com Report-Dec.7, The U.S. Food and Drug Administration (FDA) is considering a proposal to restructure user fees under the next Prescription Drug User Fee Act (PDUFA VIII) to encourage clinical drug development within the United States.

According to a summary of the FDA-Industry Steering Committee meeting held in November 2025, the agency plans to lower application fees for programmes that conduct Phase 1 trials in the United States while increasing fees for programmes that perform early-stage trials exclusively abroad. In addition, programmes without U.S. Phase 1 studies would face new annual fees after filing an Investigational New Drug (IND) application.

The stated objective is to strengthen domestic clinical research activity by providing financial incentives for sponsors to include U.S. sites in early development.

During the meeting, industry representatives questioned the choice of user-fee adjustments as the primary tool to promote U.S.-based research. They suggested that operational improvements to shorten review timelines might be more effective. The FDA acknowledged interest in such measures but noted that they fall outside the scope of user-fee negotiations.

Industry participants also requested clarification on implementation details, including eligibility criteria for reduced fees, payment schedules, and potential effects on small and medium-sized companies. The FDA agreed to develop a detailed plan for further discussion.

User fees currently represent approximately half of the FDA’s annual budget, which reached $47 billion in 2024. The current PDUFA agreement expires on 30 September 2027, and PDUFA VIII will take effect the following day. Formal negotiations with industry began in autumn 2025, with the November session concluding the first round of talks.

FDA Commissioner Marty Makary has publicly supported an overall reduction in user-fee levels, stating that lower costs would help smaller organisations advance innovative candidates into clinical testing more easily.

The Pharmaceutical Research and Manufacturers of America (PhRMA) emphasised the importance of the PDUFA framework in a recent statement: “The PDUFA system is essential to America’s edge in drug development and patient access.” The organisation noted that before PDUFA was introduced, roughly 70% of new medicines were approved first outside the United States; today, approximately 70% receive initial approval in the U.S.

Negotiations on PDUFA VIII fee structure and performance goals will continue through 2026, with final recommendations expected to be submitted to Congress in early 2027.