Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA proposal made during the negotiation process for the eighth cycle of the user fee program.
The FDA is proposing raising user fees for companies conducting Phase I clinical trials outside the U.S. in a bid to boost domestic drug development.
Speaking to industry representatives on Nov. 6, agency officials said “programs that do not conduct Phase 1 clinical trials in the U.S. would experience higher fees,” according to the minutes of that meeting. The move, the FDA said, will help “anchor clinical development in the United States.”
Industry groups—including the Biotechnology Innovation Organization, Pharmaceutical Research and Manufacturers of America and Consumer Healthcare Products Association—asked why the FDA chose to change the user fee structure instead of “leveraging efficiencies” to speed up drug reviews. The regulator said that that approach is also “of interest,” though it falls “outside of scope of the PDUFA negotiations.”
FDA officials were also unable to provide specifics about how it plans to implement these fee changes, noting that those details will be determined in future negotiation meetings.
The Nov. 6 meeting comes as the FDA and the industry negotiate the terms of the eighth cycle of the agency’s prescription drug user fee program, which is set to begin in late 2027. The scheme allows the regulator to collect certain fees from drugmakers that want to have their products reviewed. Importantly, this payment does not guarantee a favorable result, but instead gives companies certain standards to which they can hold the FDA accountable, including turnaround times and access to meetings with the regulator.
Last month, Commissioner Marty Makary floated the idea of different fees for companies conducting domestic development versus those with overseas early-stage programs. “If your Phase I trial is not in the United States, maybe you should pay a higher user fee,” Makary said during his speech at a workshop by the National Academies of Sciences, Engineering, and Medicine. He called this push the FDA’s “America-first agenda.”
Makary has also previously said he wanted to see lower user fees, noting in July that this would lower the barrier of entry for smaller drug developers, such as “small companies and individual investors and people in academics.” This idea has yet to be formally proposed as of the Nov. 6 meetings, according to the minutes that have been released so far, though it remains unclear whether the FDA has already raised it with the industry in subsequent talks.
