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# User Fee Negotiations Are Hung Up on America First Proposals
- URL: https://www.fdaweb.com/user-fee-negotiations-are-hung-up-on-america-first-proposals/
- Published: 2026-02-27T12:00:00.000Z
- Updated: 2026-09-14T13:34:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160738

FDA and drug industry negotiators working on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) confronted lingering divisions over FDA’s “America First” proposals and the structure of hiring commitments, according to just-posted [meeting minutes](https://www.fda.gov/media/191321/download?attachment&ref=fdaweb.com) from a 1/29 virtual steering committee meeting. A central focus of the meeting was the FDA’s “America First” package, which includes a proposal to limit small business fee waivers to U.S.-based applicants and to create fee incentives aimed at encouraging domestic drug development, particularly early-stage clinical trials.

Industry representatives reiterated support for strengthening U.S.-based development but raised feasibility concerns about the agency’s proposal to assess certain IND-related fees prior to the submission of a marketing application. According to the meeting minutes, companies said they are still awaiting answers to detailed feasibility questions posed earlier in January.

Industry officials warned that elements of the proposal could have unintended consequences, potentially discouraging development in the United States rather than promoting it. They emphasized that decisions about where to launch Phase 1 trials are driven primarily by development efficiency, including regulatory predictability and operational speed.

Companies also argued that new or front-loaded fees could disproportionately affect small biotech firms. In the case of over-the-counter switches, they noted, the applicant seeking marketing approval may not have controlled where earlier development activities occurred.

FDA agreed to consider the feedback. However, the minutes indicate the two sides have reached an impasse over the aspect of the proposal that would require fees to be assessed before submission of a marketing or licensing application.

During the session, the agency also outlined its proposed approach to the hiring section of the PDUFA VIII commitment letter, asserting that fulfillment of negotiated program enhancements depends on both fee collection and meeting staffing targets. FDA officials said that deadlines for commitments requiring additional staff should be structured to allow time to recruit and train personnel. The agency characterized this framework as consistent with PDUFA VII and prior authorizations. Industry asked clarifying questions, and the FDA agreed to draft specific language for inclusion in the commitment letter.

The discussion followed concerns raised earlier in the month that some FDA subgroups might not be negotiating under the assumption that the program would be staffed to its funded capacity. The agency confirmed it intends to staff the PDUFA program to the capacity funded under PDUFA VII, with any new activities under PDUFA VIII requiring additional negotiated resources.

Subgroup leaders from the pre-market, post-market safety, chemistry, manufacturing and controls (CMC), and finance teams summarized recent progress and outlined next steps. Beyond the fee dispute, the broader conversation turned to shared goals around efficiency.

Industry representatives said they are prioritizing both operational efficiency within the FDA and broader drug development efficiency. They argued that increased transparency and information sharing by the agency could streamline development programs, align submissions more closely with FDA expectations, and potentially reduce the number of formal meeting requests.

FDA officials countered that some industry proposals designed to speed development could, from the agency’s perspective, reduce operational efficiency within the review program.

The outcome of the talks will shape the next five-year authorization of PDUFA, which underpins the FDA’s ability to collect user fees from drug manufacturers in exchange for meeting performance goals tied to application review timelines and other regulatory commitments.