Marty Makary resigned as FDA commissioner on May 12, 2026, following clashes with the Trump administration over policies such as fruit-flavored vapes and mifepristone, as well as internal agency turmoil and layoffs.
The "Makary era" was characterized by informal policy changes, expedited drug review pilots, priority review vouchers, reduced clinical trial requirements, and controversial vaccine and food-regulation decisions that were often announced via press release or podcast rather than formal rulemaking.
His departure has unlocked an opportunity to unwind or reverse many of these initiatives, since they were not codified in formal guidance or regulations and can be easily revised by a new leadership team.
Kyle Diamantas, previously FDA’s deputy commissioner for food, became acting commissioner, signaling a shift in emphasis toward food safety and more conventional regulatory processes.
The Trump administration is now in a search for a new, permanent FDA commissioner, targeting someone who can rebuild trust with staff, stabilize the agency, and potentially reorient its drug-approval reforms and vaccine policies, effectively closing the chapter on the Makary era.
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[PDF] Highlights from FDA Commissioner Dr. Marty Makary's First 100 Days