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STAT·May 12·2 min read
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STAT+: Makary departs FDA amid turmoil as Diamantas, agency’s top food official, steps in

Food and Drug Administration Commissioner Marty Makary is resigning from his role after a tumultuous tenure.

May 12, 2026·read at STAT ↗

STAT PlusBreaking News Makary departs FDA amid turmoil as Diamantas, agency’s top food official, steps in His tenure was marked by personnel departures and drama, and controversies over political pressure Manage alerts for this article Email this article Share this article By Lizzy LawrenceMay 12, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.

WASHINGTON — Food and Drug Administration Commissioner Marty Makary is resigning from his role, according to an administration source familiar with the matter. Kyle Diamantas, the top food regulator at the agency, will step in as acting commissioner. Makary has served in the role for a little over a year.

The White House and spokespeople for Makary and Health and Human Services Secretary Robert F. Kennedy Jr. didn’t respond to messages seeking comment.Advertisement A group within HHS was unhappy with Makary’s leadership and had been looking into ways to remove him for months, FDA sources told STAT.

Speculation that Makary would depart intensified on Friday after the Wall Street Journal and others reported that President Donald Trump planned to fire him. HHS officials had started thinking about Makary’s replacement, according to sources familiar. STAT+ Exclusive Story Already have an account?

Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%!

Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In biotechnology, Donald Trump, drug development, FDA, HHS, Pharmaceuticals, Policy, RFK Jr., STAT+, White House Submit a correction requestReprints Lizzy Lawrence FDA Reporter Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration.

She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Newsletter The latest updates in federal health agencies, research institutes, and U.S.

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Ultragenyx Pharmaceutical Inc.2ASTELLAS
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Rare Disease2
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Rare Disease2Gene Therapy (AAV)

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