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# User Fees Could Incentivize U.S. Drug Development
- URL: https://www.fdaweb.com/user-fees-could-incentivize-u-s-drug-development/
- Published: 2025-12-04T12:00:00.000Z
- Updated: 2026-09-14T15:28:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160327

FDA told an 11/6 Industry Steering Committee meeting as part of the discussions toward the 2027 reauthorization of the Prescription Drug User Fee Act that it intends to present a proposal to charge different user fees depending on whether a company conducts Phase 1 trials in the U.S. or overseas. The *Pharmaphorum* online platform says FDA also said that in addition to higher user fees if clinical trials are not conducted in the U.S., it would introduce additional fees after an IND is filed.

The industry representatives present at the meeting reportedly asked why FDA was focusing on user fees to incentivize domestic drug development rather than introducing efficiencies that could accelerate the time required for drug development and review. FDA reportedly said it is also interested in such steps, but that they are outside the scope of PDUFA reauthorization.

FDA commissioner **Marty Makary** reportedly has said he generally favors a reduction in user fees as a way to make it easier for smaller companies to advance promising drug development programs.