Trump Ousts FDA Commissioner Marty Makary After Industry and White House Pressure

CNBC reported Tuesday that FDA Commissioner Dr. Marty Makary has been removed from his post, ending a turbulent stretch atop the nation’s top drug and food regulator. President Donald Trump confirmed the departure to reporters, describing Makary as “a wonderful man” who would “go on and lead a good life.” Multiple outlets indicated Makary had resigned, though reporting in the days prior suggested the White House was already preparing to fire him.

Diamantas Steps In as Acting Commissioner

Kyle Diamantas, who previously led food policy functions at the FDA, is set to assume the acting commissioner role on a temporary basis, according to reports cited by CNBC. Trump did not name Diamantas directly when addressing reporters. The agency faces a delicate transition period, including sensitive ongoing negotiations over reauthorization of the Prescription Drug User Fee Act, which determines the fees drugmakers pay to fund FDA reviews.

A Tenure Defined by Controversy

Makary, a surgical oncologist who built a public profile criticizing pandemic-era government policy, spent just over a year running an agency responsible for regulating drugs, food, and medical devices. His time in office was marked by significant internal turmoil, including staff layoffs and the exodus of veteran scientists. Longtime cancer regulator Dr. Richard Pazdur departed and publicly cited Makary’s leadership as his reason for leaving. Morale among remaining staff reportedly deteriorated sharply.

Makary’s regulatory record drew fire from multiple directions. Drugmakers and patient advocates pushed back against high-profile rejections of rare disease treatments. The White House grew frustrated over what it viewed as sluggish movement on priority initiatives, particularly efforts to legalize flavored vapes. The anti-abortion group Susan B. Anthony Pro-Life America separately demanded his removal, alleging he had delayed a safety review of the abortion pill mifepristone.

Industry Wary Despite the Shake-Up

One of Makary’s most polarizing personnel decisions was the appointment of Dr. Vinay Prasad to oversee vaccines and biotech reviews. Prasad, an academic and prominent podcaster, stepped down at the end of April following sustained criticism from the pharmaceutical and biotech industries. Under his watch, the FDA initially declined to review a Moderna flu vaccine before reversing course, and it twice rejected a Replimune melanoma drug candidate. A uniQure Huntington’s disease gene therapy rejection also drew sharp public criticism.

Despite the upheaval, the pharmaceutical sector has expressed caution about another leadership change at such a consequential moment for regulatory policy. Makary had promoted a priority voucher program designed to accelerate review timelines as among his key achievements. His successor now inherits both the unfinished mifepristone review and an agency workforce navigating sustained uncertainty.

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