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

Some U.S. Biotech companies plan to run early-stage clinical trials outside the U.S. Due to recent FDA uncertainty and restructuring impacts in 2025.
This shift arises from concerns about FDA staffing cuts, policy changes under the Trump administration, and slower regulatory reviews causing loss of confidence.
Executives and investors report Europeans markets like the EU and Australia offer more stability and cost advantages, prompting firms to reconsider traditional U.S.-first approval routes.
A biotech CEO highlighted that postponements of just a few weeks in obtaining FDA regulatory approval might threaten a company's viability, while noting that conducting clinical trials in Europe can reduce expenses by 30% to 40%.
The increasing tendency to start clinical trials outside the U.S. May alter the drug development landscape and diminish American dominance in the field, though companies generally plan to conduct late-stage trials and launch products within the United States.

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