Makary resigns as FDA head

Dr. Marty Makary has resigned as commissioner of the FDA, ending his 13-month tenure as head of the agency.

Kyle Diamantas, deputy commissioner for food, will serve as the acting head of the agency until a permanent replacement is found, Trump confirmed in a social media post.

Makary initially gained favor among Republicans as an outspoken critic of public health measures during the COVID-19 pandemic. He later clashed with MAHA supporters after the FDA approved updated mRNA COVID vaccines, and again with anti-abortion advocates when the agency approved a second generic version of mifepristone.

According to an AP News source, Makary resigned under pressure from Health Secretary Robert F. Kennedy Jr. and the decision was backed by the White House. An NPR source said it came down to an issue with the fruit-flavored vapes, and the pressure on Makary from the White House to authorize their sales earlier this month.

Makary often voiced the need for regulatory flexibility in the cell and gene therapy space. Under his lead, CDER and CBER jointly proposed the Rare Disease Evidence Principles (RDEP) process to facilitate the approval of drugs to treat rare diseases with very small patient populations. CBER then issued three rare disease-focused draft guidances, emphasizing greater regulatory flexibility with respect to the development and post-approval studies of CGTs.

Makary’s resignation comes after a string of departures from the agency, including Dr. Vinay Prasad, who stepped down as head of CBER for a second time in March 2026. Makary initially named Prasad, a hematologist-oncologist, CBER director in May 2025. In July 2025, Prasad resigned from CBER for the first time amid political controversy after becoming tangled in a public dispute with Sarepta, after the company refused to halt shipments of Elevidys despite an FDA request that cited recent patient deaths.