The U.S. Food and Drug Administration (FDA) is considering an increase in user fees for companies that conduct Phase I clinical trials outside the United States. The agency says this move aims to encourage more drug development activities within the country.
During a meeting with industry representatives on November 6, FDA officials stated, “programs that do not conduct Phase 1 clinical trials in the U.S. would experience higher fees.” According to the agency, this policy change is intended to “anchor clinical development in the United States.”
Industry groups such as the Biotechnology Innovation Organization, Pharmaceutical Research and Manufacturers of America, and Consumer Healthcare Products Association questioned why the FDA was altering its fee structure instead of seeking process efficiencies to accelerate drug reviews. In response, the FDA acknowledged that increasing efficiency is also “of interest,” but clarified it is “outside of scope of the PDUFA negotiations.”
Details about how these fee changes would be implemented have not yet been finalized. FDA officials indicated that further discussions will determine specifics during future negotiation meetings.
The November 6 discussion took place as part of ongoing negotiations between the FDA and industry stakeholders regarding the eighth cycle of the Prescription Drug User Fee Act (PDUFA), which is scheduled to start in late 2027. Under this program, drugmakers pay fees for their products to be reviewed by the regulator. Payment of these fees does not guarantee approval but provides companies with certain service standards from the FDA, including timelines for review and opportunities for meetings.
Last month, Commissioner Marty Makary suggested charging different fees based on whether early-stage clinical development occurs domestically or overseas. During a workshop hosted by the National Academies of Sciences, Engineering, and Medicine, Makary said: “If your Phase I trial is not in the United States, maybe you should pay a higher user fee.” He described this approach as part of an “America-first agenda.”
Makary has also expressed support for lowering user fees overall to reduce barriers for smaller developers such as small companies and academic researchers. However, according to available meeting minutes from November 6, no formal proposal on reducing fees has been introduced at this stage.
