FDA commissioner is set to resign after tumultuous tenure

Dr. Marty Makary will resign as FDA commissioner, effective Tuesday, according to a federal health official. The decision follows pressure from the White House regarding the approval of fruit-flavored vapes, an issue that reportedly led to his departure. Makary, a surgeon and health policy researcher formerly at Johns Hopkins, was confirmed in March 2025 but faced criticism from both proponents of rapid regulatory changes and traditionalists. His tenure was turbulent, marked by conflicts with the 'Make America Healthy Again' movement, led by Health Secretary Robert F. Kennedy Jr., over vaccine policies and abortion-related drug approvals. Makary approved updated mRNA COVID-19 vaccines, angering some anti-vaccine advocates, and authorized a generic version of mifepristone, disappointing opponents of abortion access. Additionally, he delayed a promised safety review of mifepristone, drawing criticism from Senator Hawley. Makary attempted to streamline FDA processes, such as consolidating adverse event reporting systems, but faced backlash for inconsistent decisions. His agency initially rejected Moderna’s mRNA flu shot application due to study design issues before reversing the stance days later, raising concerns about regulatory predictability. The rare disease community also expressed frustration over denials under his leadership, particularly under Dr. Vinay Prasad, director of the Center for Biologics Evaluation and Research. The resignation comes amid broader instability at the FDA, including mass layoffs under the Department of Government Efficiency earlier this year. Makary’s approach—pushing for single clinical trials to speed up drug approvals while also requesting additional studies—highlighted internal contradictions. His departure leaves the agency in a transitional phase, with a deputy commissioner temporarily taking over.