FDA Makes Leadership Overhaul Following Commissioner Makary’s Departure: Report
Key Takeaways
- Sudden vacancies at the top raise near-term risks for review-cycle continuity, policy coherence, and external stakeholder confidence across drugs, biologics, and vaccines.
- Makary’s departure followed internal disputes over approval decisions and Covid-19 vaccine posture, catalyzing a rapid cascade of acting appointments.
FDA undergoes leadership upheaval, leaving key drug and biologics divisions under interim control and raising concerns over regulatory continuity amid turnover at the agency’s highest levels.
FDA underwent yet another round of leadership changes, one that has left the agency without a permanent commissioner, a permanent deputy commissioner, or permanent leadership at two of its most consequential divisions.
Within days, a combination of firings and forced resignations rushed through the agency's highest ranks,
What triggered the latest round of FDA departures?
The week's turbulence traces back to
His removal set off a chain reaction that would reach aspect of the agency's leadership structure.
Kyle Diamantas, previously the FDA's top food regulator and deputy commissioner, was named acting commissioner to fill Makary's seat.2 But that appointment did little to stabilize the agency, as further departures followed in rapid succession.
Why was Tracy Beth Høeg fired from CDER?
Days after Makary's exit, Tracy Beth Høeg, the acting director of the Center for Drug Evaluation and Research (CDER), was fired. Høeg announced her dismissal via a post on X on Friday, May 16, saying, "I was fired."3 According to The Guardian, she told the New York Times and other outlets that she refused to resign before being let go.
Høeg's background was unconventional for someone leading the nation's drug regulation center, as a sports medicine physician and epidemiologist, she rose to national prominence during the Covid-19 pandemic. She had previously served as an adviser to Makary before being elevated to
Høeg was the fifth person to lead CDER in the span of a year, following high-profile departures including those of
What happened at CBER, the FDA's biologics and vaccines center?
The Center for Biologics Evaluation and Research (CBER), the division responsible for overseeing vaccines and biologics, is also seeing its leadership upended. Katherine Szarama, who had only recently stepped into the acting director role following the
Szarama has been in the position for just 10 days. According to an internal FDA memo obtained by CNBC, she will remain at the agency in a different capacity.2
Karim Mikhail, who’s been working at the FDA as an adviser after previously serving as CEO of the pharmaceutical company Amarin, has been named acting director of CBER.1
Who else was removed from FDA?
The departures were not limited to CDER and CBER. Jim Traficant, the FDA's chief of staff who had previously been chair and CEO of Citadel Sciences before joining the agency in March 2025, was also removed from his position.3 He is reportedly staying on in an advisory role, according to a Department of Health and Human Services official.1
Lowell Zeta, who had been serving as the FDA's deputy commissioner and special counsel, was named acting chief of staff to fill Traficant's vacancy.1
Sources
1. FDA drug center head fired after commissioner's exit Reuters May 16, 2026,
2. FDA shuffles top drug and biologics regulators after Makary departure CNBC May 16, 2026,
3. FDA drug chief Tracy Beth Høeg fired; vaccines chief Katherine Szarama also out The Guardian May 16, 2026,
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