Trump Confirms Makary Exit; Diamantas Named Acting Chief

• Marty Makary has resigned as FDA commissioner after 13 months, with Kyle Diamantas — a corporate lawyer with no medical degree — stepping in as acting commissioner
• The FDA now has no permanent leaders at the commissioner level, CDER, or CBER, compounding an already significant leadership deficit at the agency

FDA Commissioner Marty Makary resigned Tuesday, May 12, ending a turbulent 13-month tenure marked by mass layoffs, drug review controversies, and escalating political pressure from multiple directions. Kyle Diamantas, the agency’s deputy commissioner for food, will serve as acting commissioner while the White House searches for a permanent replacement.

Politico reports cited an administration official who said HHS Secretary Robert F. Kennedy Jr. made the call, though the White House signed off. Reuters reported that Trump told reporters Makary “was having some difficulty,” while later posting on Truth Social that he had “done a great job at the FDA.” Makary, for his part, submitted his resignation via text message to Trump, touting reforms including reduced drug review timelines and new guidance on psychedelics and hormone therapies.

According to Reuters and NBC News, the immediate trigger was the flavored vapes dispute. Trump had pressured Makary to authorize fruit-flavored nicotine products after a meeting with a tobacco industry representative, and when the FDA ultimately approved them — mango, blueberry, and menthol vapes from LA-based company Glas — Makary reportedly chose to resign rather than defend the decision at a scheduled congressional appearance. A source close to HHS leadership told NBC that Makary opposed the authorization and resigned ahead of that testimony. “It really came down to the fruit-flavored vapes issue,” a source familiar with Makary’s thinking told Reuters. “He is a principled guy, didn’t want to sign off on something he doesn’t believe in.”

But as Pharmaphorum noted, the friction predates the vape controversy. Politico had reported last fall that Makary and Kennedy were at odds over FDA vaccine policy and personnel decisions — a tension that appears to have been building throughout his tenure. Makary also faced pressure from anti-abortion Republicans pushing for tighter restrictions on mifepristone, criticism from pharmaceutical companies over inconsistent drug reviews, and scrutiny over the repeated turnover in the CBER director role, which saw five different vaccine chiefs in under a year, including Vinay Prasad’s departure, rapid reinstatement, and then final exit in April.

Despite the turbulence, Makary drove a recognizable reform agenda. As Pharmaphorum reported, his tenure saw the introduction of the Commissioner’s National Priority Voucher, which cut approval timelines for select drugs; the deployment of the ELSA AI tool to accelerate scientific review; and the launch of a real-time clinical trial reporting pilot with Amgen and AstraZeneca. “We are seeing prolonged time and wasted steps result in a lack of investment,” he said at a BIO event last year, per Pharmaphorum. Whether those initiatives survive under new leadership is an open question.

Diamantas joined the FDA in February 2025 from corporate law firm Jones Day, where he advised food and beverage clients on regulatory matters. He previously represented Abbott during litigation stemming from its infant formula recall. As Pharmaphorum noted, he is a personal acquaintance of Donald Trump Jr. and has no medical or scientific credentials — a departure from historical norms for FDA leadership. Kennedy expressed “full confidence” in Diamantas in a post on X, citing his work on food safety and the MAHA agenda. But as Public Citizen’s health research group director Robert Steinbrook told one outlet, Diamantas “had little experience regulating food when he was named the FDA’s Deputy Commissioner for Food in 2025, and he has even less experience regulating drugs, devices, and other medical products.”