After a turbulent 13 months at the helm, Food and Drug Administration (FDA) Commissioner Marty Makary has resigned, marking the end of a tenure characterized by controversy, high-profile clashes, and a revolving door of agency leadership. President Donald Trump confirmed Makary’s departure on Tuesday, May 12, 2026, just before departing for a diplomatic trip to China, bringing a dramatic close to weeks of speculation and mounting pressure from within and outside the administration.
Kyle Diamantas, the FDA’s deputy commissioner for Food, will now serve as acting commissioner, according to multiple reports from Politico, Reuters, and STAT. Diamantas steps into the role at a critical juncture for the agency, as it faces both internal upheaval and intense scrutiny over its recent decisions on drug and product approvals.
Makary’s resignation follows a series of contentious agency moves and escalating tension with top White House and Department of Health and Human Services (HHS) officials. According to Reuters, Makary had been at odds with a growing number of advisers, including Health Secretary Robert F. Kennedy Jr., as well as influential Republican lawmakers, anti-abortion groups, and even the editorial board of The Wall Street Journal. The pressure campaign reached a fever pitch in early May, culminating in President Trump’s decision to sign off on a plan to remove Makary, as reported by The Wall Street Journal and confirmed by administration sources cited in Politico.
“He’s going to go on and he’s going to lead a good life,” President Trump told reporters on Tuesday, as quoted by STAT. “He was having some difficulty. He’s a great doctor. He’s going to go on and do well. Everybody wants that job.” Trump’s comments reflected a measure of personal respect for Makary, even as he acknowledged the challenges that had defined the commissioner’s turbulent tenure.
Makary, a surgical oncologist and former faculty member at Johns Hopkins University School of Medicine, was confirmed by the Senate and took over the FDA on March 25, 2025. His appointment came at a time when the agency was already under pressure to accelerate drug approvals and respond to shifting political priorities. But Makary’s approach to leadership—marked by controversial decisions and frequent public disagreements—soon drew the ire of stakeholders across the political spectrum.
One of the most contentious issues leading to Makary’s departure was the FDA’s handling of flavored e-cigarettes and nicotine products. According to Reuters, President Trump rebuked Makary in early May 2026 for not moving quickly enough to approve fruit-flavored vapes—a product Trump had pledged to protect during his 2024 campaign. The FDA ultimately approved the products days later, but the episode reportedly became the final straw for Makary. A source familiar with his thinking told Reuters, “It really came down to the fruit-flavored vapes issue. He is at peace with the decision. He is a principled guy, didn’t want to sign off on something he doesn’t believe in.”
This disagreement was just one in a string of high-profile disputes. During Makary’s 13-month tenure, the FDA rejected several rare disease drugs, including Replimune’s advanced melanoma therapy RP1, Capricor Therapeutics’ deramiocel for Duchenne muscular dystrophy cardiomyopathy, and Disc Medicine’s bitopertin, which had previously received a Commissioner’s National Priority Voucher (CNPV). Each of these decisions sparked backlash from patient advocacy groups, pharmaceutical companies, and political commentators. The Wall Street Journal editorial page, for instance, published a series of op-eds sharply criticizing Makary’s leadership and calling for his ouster.
Makary also faced criticism for the FDA’s refusal in February 2026 to review an application for Moderna’s mRNA-based flu vaccine. The agency accepted an amended application a week later, but not before President Trump reportedly expressed his frustration directly to Makary, according to Politico.
Internally, Makary presided over a period of remarkable instability. The FDA saw significant staff reductions, with thousands of employees forced out, and a dizzying turnover in key positions. The agency cycled through five different vaccine chiefs in just one year, including one who was fired, rehired, and then left again within months. The Center for Biologics Evaluation and Research (CBER) alone saw five different leaders in less than 18 months, with Vinay Prasad departing in April 2026 and Katherine Szarama stepping in as acting director.
Veteran regulator Richard Pazdur, who resigned as head of the FDA’s Center for Drug Evaluation and Research in December 2025, pointed to pressure from Makary as a key factor in his decision to leave. Pazdur later claimed that “the wall between the commissioner’s office and the review staff has been breached” under Makary’s leadership—a sentiment echoed by others who cited mounting interference in scientific reviews.
Makary’s controversial policies extended to the creation of the Commissioner’s National Priority Voucher (CNPV) program, designed to grant expedited reviews to select therapies. The program was met with skepticism, with critics questioning both its legality and its effectiveness after the high-profile rejection of bitopertin.
Despite the turmoil, Makary remained a visible presence at the White House throughout late 2025, attending policy announcements related to drug pricing and health care reform. He was on hand as President Trump unveiled the Most Favored Nation drug pricing initiative, which saw major pharmaceutical companies like Pfizer, Eli Lilly, and Novo Nordisk agree to lower prices on certain medicines.
By November 2025, rumors were swirling that the Trump administration was considering limiting Makary’s role or replacing him altogether—a move he managed to survive until this week. His planned testimony before the Senate Appropriations Committee regarding the administration’s fiscal 2027 budget proposal for the FDA, scheduled for May 13, 2026, is now in question.
With Makary’s resignation, the United States finds itself without a permanent head for both the FDA and the Centers for Disease Control and Prevention, as well as several other key public health agencies. The White House is actively searching for a permanent replacement, with former FDA Commissioner Steve Hahn and former acting commissioner Brett Giroir reportedly among the candidates under consideration, according to Reuters. However, finding willing and qualified candidates has proven difficult, especially given the agency’s recent upheaval and the polarizing influence of Health Secretary Kennedy.
Makary’s departure is the latest chapter in a period of “predictable volatility,” as analysts at Truist Securities put it, that has gripped the FDA and the broader health sector. While the agency’s leadership may be in flux, the challenges it faces—balancing political demands, public health imperatives, and scientific integrity—remain as pressing as ever.
As the dust settles, all eyes will be on Kyle Diamantas and the next permanent commissioner to see whether they can bring stability and renewed confidence to one of America’s most critical public health institutions.