Makary exits FDA after turbulent tenure

WASHINGTON – Dr. Marty Makary has resigned as the Food and Drug Administration’s commissioner after just over a year at the helm, marking another major leadership shakeup within the Trump administration’s health apparatus.

Marty Makary’s future at the FDA hangs in the balance

Reports that President Trump approved plans to remove FDA Commissioner Marty Makary have fueled uncertainty around the agency as disputes over vaping, abortion pills and drug approvals intensify.

Chain Drug ReviewThorvardur de Shong

Multiple media outlets reported Tuesday that Makary stepped down amid mounting pressure from within the Department of Health and Human Services and mounting criticism of several high-profile regulatory and policy decisions. Kyle Diamantas, the FDA’s deputy commissioner for food, will serve as acting commissioner.

President Donald Trump confirmed Tuesday afternoon that Makary had departed, calling him “a wonderful man” and indicating that the agency’s deputy would temporarily assume leadership duties.

Makary, a Johns Hopkins surgeon and professor emeritus who became nationally known during the COVID-19 pandemic for criticizing aspects of the federal response, took over the FDA in 2025. His tenure was marked by internal upheaval, staffing turnover and growing tensions with lawmakers, industry stakeholders and White House officials.

According to reports, frustration within the administration intensified over several issues, including the FDA’s handling of flavored vape authorizations and the agency’s ongoing review of abortion-pill regulations tied to mifepristone. Anti-abortion groups and Republican lawmakers increasingly pressured Makary to restrict telehealth access to the drug, while vaping advocates criticized what they viewed as delays in approving flavored e-cigarettes.

Makary also faced backlash from parts of the biopharmaceutical industry over what companies described as inconsistent regulatory standards for drug approvals, particularly for rare-disease treatments. Several controversial FDA decisions during his tenure drew criticism from patient advocacy groups and biotech firms.

At the same time, Makary promoted initiatives to accelerate certain drug approvals, including a priority voucher program intended to expedite reviews of therapies deemed strategically important while encouraging lower drug costs.

The FDA also saw significant personnel turnover under Makary’s leadership, including the departures of longtime officials such as former Oncology Center of Excellence Director Richard Pazdur and other senior regulators. Staff morale reportedly declined after layoffs and organizational changes tied to broader HHS restructuring.

Diamantas, who joined the FDA in 2025 after a corporate law career, currently oversees the agency’s food safety and nutrition programs. He has emerged as a key figure in the administration’s “Make America Healthy Again” agenda and has recently taken a more prominent public role in discussing FDA policy priorities.

The FDA and HHS have not issued formal comments on the leadership change.