Marty Makary, the commissioner of the Food and Drug Administration (FDA), is stepping down after just over a year in the role, the White House confirmed Tuesday (May 12). The resignation comes amid months of turmoil at the agency, with staff turnover, leadership changes, and public clashes over key health and regulatory decisions. According to a White House official, the decision was linked to “process at the FDA” rather than a specific controversy, and there is “no bad blood” between President Donald Trump and Makary. Robert F. Kennedy Jr., Secretary of Health and Human Services, reportedly pressed for Makary’s departure.
Kyle Diamantas, currently the FDA’s chief for foods and an attorney with ties to Donald Trump Jr., will serve as acting commissioner until a permanent replacement is nominated and confirmed by the Senate. The FDA oversees billions of dollars in medicines and consumer goods, and its top job often involves balancing scientific standards and political demands.
Makary’s tenure was marked by deep staff dissatisfaction and a string of high-profile controversies. Nearly all senior career officials at the FDA either resigned, retired, or were pushed out during the first year of President Trump’s second term. The agency saw rapid changes in leadership, particularly in its drug and vaccine divisions.
Makary, a former Johns Hopkins surgeon who rose to prominence criticizing COVID-19 health measures, struggled to win the confidence of FDA staff. His efforts to speed up drug reviews and incorporate artificial intelligence into evaluations were met with skepticism by pharmaceutical executives, who prioritize consistency and predictability. Some initiatives, like faster drug review programs, drew questions from Congress about their legality.
He also faced criticism from anti-abortion groups for what they saw as slow action on the abortion pill mifepristone, and from vaping industry leaders who accused him of blocking new product approvals. Just last week, the FDA reversed its position and authorized the first fruit-flavored e-cigarettes, a move widely seen as resulting from direct pressure by President Trump.
Makary’s deputy, Dr. Vinay Prasad, was twice forced out over disputes with specialty drugmakers and rare disease patient groups. Prasad’s controversial vaccine policies led to further confusion, including a now-reversed decision not to consider Moderna’s mRNA flu vaccine. These ongoing controversies and staff departures resulted in what many described as “endless chaos” inside the FDA.
Moving forward, the fate of many of Makary’s initiatives is uncertain, as most have not gone through the formal rulemaking process and could be easily overturned.
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