Opinion: Former FDA commissioners: Heidi Overton has an opportunity to strengthen the FDA — SkimNews
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- Heidi Overton faces a Senate health committee confirmation hearing Thursday to lead the FDA, with former commissioners urging her to rebuild a gutted agency and sustain biomedical innovation review.
- China now hosts more Phase 1 clinical trials than the U.S., delivering innovations that once reached American patients first, the former FDA chiefs wrote.
- The FDA lost approximately 3,500 employees in April 2025 layoffs plus additional voluntary departures, eliminating entire offices that drafted policy and project managers who kept reviews on schedule.
- Acting Commissioner Kyle Diamantas has begun rebuilding with new job postings, and this month FDA leadership made permanent the acting heads of the drug, biologics, and tobacco centers — two of whom are agency veterans.
- Scott Gottlieb (FDA commissioner 2017-2019) and Mark McClellan (2002-2004) wrote the opinion, urging Overton to restore vaccine regulation to 'predictable, science-driven processes' and address preventable deaths from combustible tobacco.
Why it matters: The FDA's ability to review gene therapies, AI medical tools, and new vaccines depends on retaining career physicians and scientists after April's 3,500-worker reduction. Overton's Thursday hearing is the first test of whether a permanent commissioner can restore morale, refill gutted policy offices, and respond to China's accelerating clinical trial dominance before the U.S. loses more ground in biomedical innovation.
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