Makary resigns as commissioner of US FDA

Dr Marty Makary has resigned as the US Food and Drug Administration (FDA)’s Commissioner after a 13-month tenure.

The agency’s Deputy Commissioner for Food, Kyle Diamantas, is stepping in acting FDA Commissioner.

The news follows earlier reports by media outlets, including the Wall Street Journal, of President Trump signing off firing Dr Makary. On the commissioner’s resignation, Trump said on Truth Social, that the former commissioner had “done a great job at the FDA. So much was accomplished under his leadership.”

Dr Makary proposed several policies as commissioner, including a plausible mechanism framework, the FDA’s first pathway that supports ultra-rare disease drugmakers along their approval journey.

Trump’s decision resulted partly from his previous disagreement on Dr Makary’s concerns about authorising fruit-flavoured e-cigarettes in the US. The president ultimately applied pressure and these products were later approved.

Writing on LinkedIn, Dr Richard Graham, Co-founder of clinical trials platform provider, TruTechnologies, remarked that Dr Makary’s resignation “comes just weeks after the agency announced major steps toward “real-time” clinical trials. Regulatory progress must be sustained through leadership transitions, and the long-term goal of modernising clinical trials can’t depend on a single leader.

“For the US to remain competitive, modernisation can’t be limited to ‘real-time’ clinical trials — it has to extend to how trials are designed, conducted and monitored in real time… Sponsors cannot control every leadership transition or shift in regulatory priorities. But they can control the quality, integrity, and speed of their own clinical trial execution.”

Dr Makary inherited an FDA in crisis after the DOGE changes, which included the firing of thousands of employees…what we need now is strong, stable and science-driven leadership at the FDA”

Staffing pressures, driven by other key leadership changes were a recurring feature during Dr Makary’s tenure. Most recently, the exit of former head of the Center for Biologics Regulation and Evaluation (CBER), Dr Vinay Prasad. Last December, Dr Richard Padzur retired after less than a month as director of the Center for Drug Evaluation and Research (CDER). Dr Tracy Beth Hoeg took the helm as the agency’s fifth CDER leader in 2025. The division’s former director, George Tidmarsh resigned that November.

John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), said: “Dr Makary inherited an FDA in crisis after the DOGE changes, which included the firing of thousands of employees. These staffing and morale challenges were compounded by constant leadership changes over the past year and questions around shifting FDA standards for drug approvals. What we need now is strong, stable and science-driven leadership at the FDA.”