Marty Makary Resigns as FDA Commissioner
CNBC reported Tuesday that FDA Commissioner Marty Makary has resigned, ending a fractious tenure at the top of America’s most powerful drug regulator. President Donald Trump announced the departure on Truth Social and named Kyle Diamantas, a former senior food official at the agency, as acting commissioner.
A Tenure Defined by Conflict
Makary, a surgical oncologist who built his public profile criticising the government’s pandemic response, held the role for just over a year. His time leading the Food and Drug Administration was defined by internal disorder, mass departures of career scientists, and escalating friction with drugmakers and patient advocacy groups. Several high-profile rejections of rare disease treatments drew particular condemnation from the pharmaceutical sector.
The White House grew frustrated with Makary’s pace on key political priorities. Chief among them was the legalisation of flavoured vapes, a move Trump has pushed aggressively. The influential Susan B. Anthony Pro-Life America group separately called for his removal over how the FDA handled the abortion pill mifepristone. Makary had reportedly delayed a safety review of the drug, which can be mailed into states restricting abortion access.
Leadership Turmoil Had Been Building for Months
Staff morale inside the FDA had been deteriorating well before the resignation. Waves of layoffs and voluntary departures stripped the agency of experienced regulators. Dr. Richard Pazdur, a longtime cancer treatment official, cited Makary’s leadership directly when he announced his own exit.
Among the most divisive figures Makary brought in was Vinay Prasad, who oversaw vaccines and biotech approvals before leaving at the end of April. Prasad drew fire for initially blocking a review of Moderna’s flu shot, a decision later reversed, and for rejecting a Huntington’s disease gene therapy from uniQure. The pharmaceutical sector viewed his tenure as deeply disruptive.
What Comes Next for the Agency
Health and Human Services Secretary Robert F. Kennedy Jr. made the final call to replace Makary, a senior administration official confirmed to CNBC. The White House said it hopes to announce a permanent nominee within weeks, though no names have been put forward.
Makary’s successor will inherit unresolved business on multiple fronts. The mifepristone review carries significant political risk. The pharmaceutical industry is also in the middle of negotiating reauthorisation of the Prescription Drug User Fee Act, which governs the fees drugmakers pay to fund FDA reviews. Industry groups appear uneasy about further instability at the top of the agency.
The FDA vacancy adds to a broader pattern of leadership gaps across federal health and regulatory bodies, raising fresh questions about institutional continuity at a critical moment for drug approval pipelines.
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