A Quick Explainer on the FDA's Leadership Shakeups
There's been a lot happening. Here's a simple guide for catching up with recent personnel changes.
It’s been hard to keep up with all the personnel changes at the FDA recently. In the last few weeks alone, the agency has lost its commissioner, the heads of both its drug and biologics review centers, and its chief of staff.
Here’s what happened and who’s sitting in which chair right now in case you’ve been too busy to be following the news.
Makary resigns as commissioner
On May 12, FDA Commissioner Marty Makary resigned after a little over a year in the role. The sort of “proximate” cause was an acute clash over the agency’s first-ever authorization of flavored e-cigarettes. Multiple outlets reported that President Trump pressured Makary to approve fruit-flavored vapes from Glas Inc., which Makary opposed. Rather than testify before Congress the next day defending a decision he didn’t support, he stepped down.
Makary’s tenure has been pretty bumpy from the start. Mass layoffs hit the agency under DOGE, senior career officials left or were reportedly pressured out, and the agency drew criticism from both industry and public health groups over inconsistent drug review decisions. Career FDA staff told CBS News there was widespread relief inside the building when he resigned.
Kyle Diamantas, the FDA’s deputy commissioner for food, stepped in as acting commissioner. Diamantas is a lawyer, not a physician or scientist, which is unusual for the role. According to CNN, the White House hopes to nominate a permanent replacement by early June. No candidate has been publicly named.
Høeg leaves CDER
Three days after Makary’s exit, Tracy Beth Høeg was, in her own words, fired as acting director of CDER, the center responsible for reviewing prescription and OTC drugs, generics, and biological therapeutics.
Høeg had held the role since December 2025 and was the fifth person to occupy it during the Trump administration.
Here’s the full CDER leadership chain since January 2025:
Jacqueline Corrigan-Curay (acting)
George Tidmarsh (resigned amid a personal conduct probe in November 2025)
Richard Pazdur (retired after a brief stint)
Høeg, and now Michael Davis.
Davis is a longtime FDA career official and psychiatrist who served as CDER’s deputy center director. He has an MD/PhD from Case Western Reserve and spent years in CDER’s Office of New Drugs reviewing psychiatric drugs before moving into senior leadership. He is the new acting CDER director.
Høeg was known for her skepticism toward vaccines and some antidepressants, positions aligned with HHS Secretary Robert F. Kennedy Jr. During her time at FDA, she led an overhaul of the childhood immunization schedule that reduced the number of recommended vaccines for children. That drew strong criticism from mainstream public health organizations.
Szarama replaced at CBER (after 10 days)
Over at CBER, which oversees vaccines, gene therapies, blood products, and biologics, Katherine Szarama was replaced as acting director after roughly 10 days on the job. Szarama had stepped in when Vinay Prasad left at the end of April.
Prasad’s own CBER tenure was a saga. He was first appointed in May 2025 after Peter Marks resigned over vaccine policy disagreements with RFK Jr. Prasad left in July 2025, then came back two weeks later, then departed again in April 2026, officially to return to his faculty position at UCSF.
Szarama’s replacement is Karim Mikhail, a former biopharma executive who spent 20+ years at Merck and later served as CEO of Amarin Corporation. He joined the FDA last year as a senior advisor in the Office of the Commissioner and is now CBER’s fourth acting director and sixth leader since January 2025.
Other changes
The agency’s chief of staff, Jim Traficant, was also removed. Lowell Zeta is now acting chief of staff. Rich Danker, a top HHS spokesman who had worked with Makary on communications strategy, resigned over the flavored e-cigarette decision. HHS Director of Public Strategy Mitchell Hailstone also departed recently.