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FDA Commissioner Marty Makary Resigns, Kyle Diamantas Steps In as Acting Head
After roughly 14 months leading the agency and recent reports of the Trump administration planning his removal, FDA Commissioner Marty Makary, MD, MPH, has resigned.
US Food and Drug Administration (FDA) Commissioner Marty Makary, MD, MPH, resigned from his position on May 12, 2026, following weeks of reports that the Trump administration was planning his removal. Kyle Diamantas, JD, the Agency's Deputy Commissioner for Food, has been named acting commissioner while a permanent replacement is identified.
The resignation marks one of the fastest commissioner departures in modern FDA history. Makary served in the role for just over a year, having been confirmed on March 25, 2025, by a bipartisan vote of the US Senate as the 27th Commissioner of Food and Drugs.
Pressure Preceded the Departure
Reports of Makary's potential exit emerged publicly in early May after the Wall Street Journal and other outlets reported that US President Donald Trump had authorized a plan to remove him. According to Newsmax, citing the Wall Street Journal, Trump grew frustrated with Makary over delays related to flavored vaping products.
Sources within HHS had reportedly been exploring ways to remove Makary for months prior to his departure. His tenure was marked by internal disagreements, complaints from regulated industries, and staff turnover across several program areas.
Makary's Tenure and Regulatory Record
Prior to leading the FDA, Makary was a surgical oncologist and chief of Islet Transplant Surgery at Johns Hopkins University School of Medicine, where he held an endowed chair in gastrointestinal surgery and was a full professor with tenure.
During his tenure, Makary advanced several positions that drew significant attention from the medical and scientific communities, including calls for large placebo-controlled trials of COVID-19 vaccines in lower-risk age groups and policy shifts in the Agency's approach to drug approvals. In May 2025, Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, MD, published a perspective in the New England Journal of Medicine announcing that the FDA would restrict COVID-19 vaccine recommendations to adults 65 years of age and older or those at high risk of serious illness, while requiring manufacturers to conduct additional studies evaluating vaccine benefits in children and healthy younger adults.
Makary's time at the Agency also coincided with significant workforce reductions, turnover among senior staff, and ongoing debate about the appropriate role of regulatory and scientific independence at the FDA.
What Comes Next for the FDA
Diamantas brings a legal and policy background to the acting commissioner role. As Deputy Commissioner for Food, he led the FDA's Human Foods Program, overseeing nutrition and food safety activities, resource allocation, and risk-prioritization strategy. He has also served as a liaison between the FDA, HHS, and the White House, and has represented the Agency in dealings with foreign governments and international organizations.
Names reported to be under consideration for the permanent commissioner role include former FDA Commissioner Stephen Hahn, MD, who led the Agency from 2019 to 2021, and former Acting Commissioner Brett Giroir, MD.
For clinicians, the period of transition raises practical questions about the pace and predictability of therapeutic approvals, vaccination policy guidance, and regulatory decision-making across FDA centers, several of which are currently operating under acting leadership. The direction a permanent commissioner will bring to these functions remains to be seen.
References
STAT News. FDA Commissioner Marty Makary resigns, replaced by Kyle Diamantas. May 12, 2026. Accessed May 12, 2026. https://www.statnews.com/2026/05/12/fda-commissioner-marty-makary-resigns-kyle-diamantas-acting/
FDA. Martin A. Makary, MD, MPH, Sworn in as FDA Commissioner. April 2025. Accessed May 12, 2026. https://www.fda.gov/news-events/press-announcements/martin-makary-md-mph-sworn-fda-commissioner
Pharmaceutical Executive. President Trump Planning to Fire FDA Commissioner Marty Makary: Report. May 2026. Accessed May 12, 2026. https://www.pharmexec.com/view/president-trump-planning-fire-fda-commissioner-marty-makary-report
FDA. Kyle Diamantas J.D. April 9, 2026. Accessed May 12, 2026. https://www.fda.gov/about-fda/fda-organization/kyle-diamantas
