Trump administration puts "America First" twist on drug reviews
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The Trump administration's push to reshore drug development is becoming part of efforts to renew the user fee system that pays for review of new medicines.
Why it matters: "America First" incentives the administration is proposing would add a political twist to what's been a bipartisan process, but could gain favor as policymakers look for ways to reduce dependence on China.
Driving the news: The administration wants to cut Food and Drug Administration new drug application fees in half for companies that include data from at least one early-stage clinical trial anchored in the United States after Oct. 1, 2027.
- It also would offer a 50% reduction for applications to expand the use of an "orphan drug" for a rare condition to a second disease.
- And it would restrict eligibility for waivers exempting small businesses from application fees so that they only go to U.S. companies.
The proposals are part of a package of changes that Congress is due to take up before the FDA user fees expire in September 2027, according to a Federal Register filing last week.
- The agency and industry groups including PhRMA and the Biotechnology Innovation Organization have been negotiating elements of a five-year renewal agreement since early this year.
- But those talks have come as the administration presses to shift more pharma manufacturing and research to the U.S. Former FDA commissioner Marty Makary outlined steps including priority vouchers that cut review times for manufacturers making critical drugs in the U.S.
Yes, but: Some past efforts have raised questions from Democrats about whether the administration is putting politics over science or could favor drug companies liked by President Trump.
- The "America First" provisions would change the application fee structure by tying cut rates to the location of clinical trials.
- Congress in the past has been willing to preserve the underlying user fee structure on a bipartisan basis while changing or stripping out more politically charged provisions, Raymond James analyst Chris Meekins wrote in a note.
- "As a result, we would expect the core [user fee] agreement to remain largely intact, while the America First provisions face some greater uncertainty," Meekins wrote.
The FDA included financial incentives for sponsors in the agency's user fee agreement "to deliver on the Trump administration's commitment to bring drug development back to the United States," Department of Health and Human Services spokesperson Emily Hilliard said.
- It dovetails with a broader effort dubbed "Operation TrialBlazer" aimed at accelerating clinical research and addressing an industry shift that's seen a growing share of early-stage clinical research move overseas.
What's next: The FDA has scheduled a Sept. 16 public meeting to discuss the user fee reauthorization.
- China hawks in Congress also are pushing legislation that would require the Treasury Department to review U.S. pharmaceutical licensing deals, joint ventures and equity investments with Chinese companies.
- This would be the same scrutiny that's required for semiconductors, quantum information technology, and AI.
