FDA could hike user fees for ex-US drug programmes

The next iteration of FDA user fees could see the charges for programmes that run clinical early-stage trials in the US fall, and rise for those in which studies are conducted abroad, in a bid to incentivise domestic drug development.

The proposal, shared in a summary (PDF) of an FDA and Industry Steering Committee meeting held last month, aims to "anchor clinical development in the […] US" by reducing the application fee for programmes that conduct phase 1 trials there.

At the same time, the FDA would not only raise the user fees for overseas programmes that do not include phase 1 trials in the US, but would also introduce additional annual fees after an Investigational New Drug (IND) application is filed.

The move is being viewed as another element of the US reacting to the threat of losing its position in biopharma R&D to other countries, particularly China, which has emerged as a major source of new therapeutic candidates in recent years.

According to the document, industry representatives asked the agency why it was focusing on user fees to incentivise domestic drug development, rather than introducing "efficiencies that could accelerate the time required for drug development and review."

According to the regulator, such measures are also of interest, but lie outside the scope of the user fee negotiations.

The industry reps also asked for details of how the changes would be implemented – for example, the criteria for reduced application fees, the timing of fee payments, and the impact on small and midsize companies – and the FDA "agreed to propose a plan for future discussions about the fee incentives proposal."

User fee programmes accounted for a little less than half of the FDA's overall funding of $47 billion in 2024, and are authorised in five-year blocks, with the next for prescription drugs (PDUFA VIII) due to come into effect on 1st October 2027. Negotiations with industry are now underway, and the November meeting marked the end of the first week of talks.

Ahead of the talks, FDA Commissioner Marty Makary said he was in favour of reduced user fees overall as it would make it easier for smaller companies to advance promising programmes into the clinic.

In a recent blog post, the PhRMA industry organisation said that the PDUFA system is "essential to America's edge in drug development and patient access," pointing out that 70% of medicines were approved first in other countries before it was introduced, and now 70% are cleared first in the US.

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