FDA upheaval pushes some biotech firms to plan early trials out of US

Maggie Fick

Wed, May 14, 2025, 1:06 AM 5 min read

By Maggie Fick

LONDON (Reuters) -Some U.S. biotech companies are considering moving early-stage trials of caller medicines extracurricular the United States arsenic interest grows that layoffs and argumentation changes astatine the drugs watchdog nether the Trump medication whitethorn hold regulatory reviews, executives, investors, and consultants told Reuters.

The U.S. Food and Drug Administration is seen arsenic the planetary golden modular for cause regularisation and companies typically question American support archetypal due to the fact that it provides entree to the world's astir lucrative cause market.

But wide layoffs, enactment exits and the restructuring of the FDA nether President Donald Trump are prompting immoderate smaller biotechs to rethink accepted pathways for bringing caller medicines to market.

Reuters spoke to 7 biotech executives, investors, and consultants who said that the unit departures and argumentation changes astatine the FDA had prompted immoderate firms to see launching trials successful different planetary markets - specified arsenic the European Union and Australia - and engaging with regulators successful those regions earlier successful the cause improvement process.

"We cognize that crossed our companies, the discussions see whether to spell ex-U.S. due to the fact that of caller FDA uncertainty," said Peter Kolchinsky, managing spouse astatine RA Capital, a large capitalist successful early-stage biotech firms and publically traded companies with astir $9 cardinal successful assets nether management.

The FDA did not respond to a petition for comment. U.S. Health Secretary Robert F. Kennedy Jr. has said that the agency's restructuring aims to streamline functions specified arsenic IT and communications, and trim conflicts of involvement among its unit and advisors.

Consultant Matthew Weinberg of ProPharma Group said his steadfast is fielding much inquiries from biotech companies astir preparing filings with the European Medicines Agency and mounting up objective trials - a displacement helium attributes to increasing concerns astir FDA stability.

"Historically, companies went to the U.S. first. That whitethorn beryllium changing," helium said.

It is unclear if biotech companies' expanding engagement with the EMA marks a existent displacement oregon a maneuver to unit the FDA, fixed the value of the U.S. market, a root with cognition of the substance told Reuters.

An EMA spokesperson said it has not seen an summation successful technological proposal requests oregon objective proceedings applications, noting it would beryllium aboriginal for immoderate specified shifts to beryllium reflected successful submissions.

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A nonaccomplishment of assurance successful the FDA could reshape cause development, trim U.S. enactment successful innovation, and summation costs for the struggling biotech sector, 5 of those interviewed said.