On May 12, 2026, Dr. Marty Makary resigned as commissioner of the Food and Drug Administration (FDA), ending a turbulent 13-month tenure that placed him at the center of some of the nation’s most contentious public health debates. His departure, confirmed by President Donald Trump and widely reported by outlets including CBS News, CNBC, and NPR, came after weeks of mounting speculation, internal dissent, and high-profile policy clashes that ultimately left the agency reeling and its future direction uncertain.
Makary’s exit marks the fourth major shakeup in the Trump administration this year, following the departures of Homeland Security Secretary Kristi Noem, Attorney General Pam Bondi, and Labor Secretary Lori Chavez DeRemer. But the FDA, which regulates everything from drugs and vaccines to tobacco and food, occupies a unique position in American life, overseeing about one-fifth of U.S. consumer spending. The agency’s leadership is always consequential, but rarely has it been so hotly contested—or so publicly scrutinized—as during Makary’s brief and stormy stewardship.
The immediate catalyst for Makary’s resignation was a dispute over e-cigarette policy. On May 6, under heavy pressure from President Trump and the vaping industry, the FDA approved fruit-flavored vapes from Glas Inc.—a move Makary had initially resisted, citing concerns about youth access and public health. According to The Wall Street Journal and CBS News, Trump’s insistence on fulfilling a 2024 campaign promise to legalize flavored vapes ultimately forced Makary’s hand. One source told CBS News that Makary “didn’t want to approve the flavored varieties but had been forced to by other members of the administration.”
Makary’s tenure was also dogged by controversy over the abortion drug mifepristone. Republican lawmakers and anti-abortion groups, including Susan B. Anthony Pro-Life America, accused him of slow-walking a promised FDA safety review of the medication, which had become a flashpoint after the Biden administration expanded access via telehealth and mail. Reports from Bloomberg News and NPR indicated that Makary asked officials to delay the release of the review until after the 2026 midterm elections, further fueling conservative calls for his ouster. As NPR noted, “Makary upset some in the MAHA movement when the agency approved updated mRNA vaccines against COVID-19, and has disappointed those who oppose abortion by approving a second generic version of mifepristone and not completing a promised safety review of the medicine.”
President Trump, speaking to reporters on the White House South Lawn, was effusive in his praise for Makary, calling him a “great guy” and a “friend.” “He was having some difficulty. You know, he’s a great doctor. And he was having some difficulty. But he’s going to go on and he’s going to do well,” Trump said, as reported by CBS News and NPR. On Truth Social, the president posted a screenshot of Makary’s resignation text, in which the departing commissioner wrote, “It’s been the honor of a lifetime to serve as your FDA Commissioner. I am forever grateful.”
Trump also announced that Kyle Diamantas, the FDA’s deputy commissioner for food, would serve as acting commissioner. Diamantas, a lawyer rather than a physician, steps into the role at a time of considerable uncertainty. According to CBS News, career FDA officials expressed “widespread joy and relief” at Makary’s resignation, citing frustrations with his “endless self-promotion,” “micromanaging,” and lack of transparency. One senior official told the outlet that Makary’s management style had forced “virtually impossible levels of work on divisions that are significantly understaffed right now” due to an exodus of veteran scientists.
Indeed, morale at the FDA had plummeted during Makary’s tenure, with high-profile departures such as longtime cancer regulator Dr. Richard Pazdur, who specifically cited Makary’s leadership as his reason for leaving, according to CNBC. Vinay Prasad, a key agency official and Makary ally overseeing vaccines and biotech treatments, also resigned at the end of April amid mounting criticism from the biotech and pharmaceutical industries. Prasad’s controversial decisions—such as rejecting Moderna’s flu shot application and a Huntington’s disease gene therapy from uniQure—sparked industry backlash and raised questions about regulatory predictability at the FDA.
Makary’s approach to streamlining the agency—such as consolidating voluntary reporting systems for drug and device side effects—was intended to improve efficiency but often clashed with established norms and staff expectations. He pushed for single pivotal clinical trials to speed up drug approvals, yet the agency under his watch also requested additional studies from companies, creating confusion and frustration among drugmakers and patient groups. The FDA’s reversal on Moderna’s flu shot, after initially refusing to review the application, became emblematic of the agency’s unpredictable stance and further eroded trust in its leadership.
The pharmaceutical industry, meanwhile, watched the leadership shakeup with apprehension. As CNBC reported, the sector is currently negotiating the reauthorization of the Prescription Drug User Act Fee, which funds much of the FDA’s review process. “The pharmaceutical industry appears wary about a shakeup at the top of the FDA,” the outlet noted, especially as the agency faces a backlog of new drug applications and mounting pressure to accelerate approvals for rare disease treatments.
Makary, a British-American surgeon and professor emeritus at Johns Hopkins, was confirmed as FDA commissioner in March 2025. He was a vocal supporter of the Make America Healthy Again movement and had been highly critical of the federal government’s COVID-19 response. His confirmation came just a week before mass firings by the Department of Government Efficiency left hundreds of FDA positions vacant, a move intended to streamline operations but which many career staffers say left the agency dangerously understaffed.
Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA, ultimately made the decision to replace Makary, according to a senior administration official cited by CNBC. The administration hopes to name a permanent nominee in the coming weeks, though the official cautioned that it is “too early to name potential replacements.” The transition comes at a time when the FDA is facing not only internal upheaval but also external challenges, from ongoing public health threats like the hantavirus to the ever-present debates over drug pricing, abortion access, and tobacco regulation.
Makary was scheduled to testify on Capitol Hill on May 13, but the hearing was postponed in the wake of his resignation. Kyle Diamantas is now expected to represent the agency when the hearing is rescheduled, according to CBS News. Despite the turmoil, some within the FDA expressed optimism about the agency’s future. “He’s an outstanding person and great leader, with high integrity and sound judgment,” one official said of Diamantas.
As the FDA faces its next chapter, the agency and its new acting head will have to navigate not only the fallout from Makary’s controversial tenure but also the broader political, scientific, and public health challenges that define its mission. For now, the nation’s top regulator is once again in transition, with its staff, stakeholders, and the public watching closely to see what comes next.