Food and Drug Administration Commissioner Marty Makary speaks during an announcement at the Department of Health and Human Services on December 18, 2025 in Washington, DC.
Alex Wong | fake images
Dr. Marty Makary resigned as FDA commissioner on Tuesday, ending a controversial tenure at the health agency.
In a post on Truth Social, President Donald Trump said Kyle Diamantas, who previously worked as a top food official at the FDA, will take over as acting commissioner. In earlier remarks to reporters, Trump called Makary a “wonderful man” and said, “He's going to go on and lead a good life.”
Trump shared a second post showing an alleged resignation text from Makary. In the message, Makary touted his role in the FDA's priority review process that expedited some drug approvals, among other changes at the agency.
A Truth Social post by US President Donald Trump about FDA Commissioner Marty Makary.
Donald Trump via Truth Social
A senior administration official confirmed that Makary resigned on Tuesday, after days of reporting that the White House planned to fire him. Health and Human Services Secretary Robert F. Kennedy Jr. made the decision to replace Makary, the official added. The administration hopes to name its candidate to replace Makary in the coming weeks, although the official cautioned that it is too early to name potential replacements.
Makary, a surgical oncologist known for criticizing the government's management of the Covid pandemic, served as head of the agency responsible for regulating food, drugs and medical devices for more than a year.
His tenure was marked by internal dysfunction and turmoil in FDA leadership, along with a growing backlash from drugmakers, doctors and patient groups to regulatory decisions, including high-profile rejections of some rare disease treatments. At the same time, the White House reportedly became increasingly impatient with what it saw as its slow pace on key Trump policy initiatives, such as the legalization of flavored vapes.
The influential Susan B. Anthony Pro-Life America organization had also called for Makary's ouster over the FDA's handling of the abortion pill mifepristone. Makary was reportedly slow to conduct a review of the safety of the pill, which can be mailed to states that have limited abortion. Makary's successor will inherit that review and the complicated politics associated with abortion.
The senior administration official said they could not point to a single issue that led to Makary's ouster, but said it was an accumulation of many problems. Abortion was one of those issues.
Despite the controversy surrounding recent drug rejections, the pharmaceutical industry appears cautious about a shakeup at the top of the FDA. The pharmaceutical industry is negotiating the reauthorization of the Prescription Drug User Fee Act, which outlines the fees the FDA charges drug makers to fund their reviews.
Agency staff morale had plummeted after layoffs and departures of career scientists from the agency, including veteran cancer regulator Dr. Richard Pazdur, who cited Makary's leadership as his reason for leaving. Meanwhile, distrust of leadership has reportedly increased among staff who remained.
Among Makary's most polarizing appointments was Vinay Prasad, who served as a key agency official overseeing vaccines and biotech treatments before resigning in late April. Prasad, an outspoken academic and podcaster, left the agency after growing criticism of the FDA within the biotech and pharmaceutical industries and among former health officials.
For example, the FDA initially declined to review Moderna's flu vaccine, a decision the biotech company said was inconsistent with the agency's previous guidance and stemmed specifically from Prasad. The FDA later changed course on the vaccine.
Prasad also faced backlash earlier this year for his rejection of a gene therapy for Huntington's disease from uniQure, which claimed the FDA required him to perform fake brain surgery to test whether the treatment works. In a CNBC interview in March, Makary appeared to criticize that treatment without naming him.
In April, the FDA rejected Replimune's melanoma drug candidate for the second time after an initial rejection in July. The agency cited insufficient evidence of effectiveness and took issue with the single-arm trial design.
In an interview with CNBC in May, Makary said that three independent teams came to the same conclusion about the drug and that the FDA has made no “corrupt deals.”
“I don't work for Replimune, I work for the American people and support FDA scientists,” Makary said in the interview with CNBC's David Faber.
In March, Sen. Ron Johnson, R-Wis., announced an investigation into the FDA's rejection of treatments for rare diseases.
To install a new commissioner, Trump will likely need to win the support of Sen. Bill Cassidy, a former doctor who nearly blocked the confirmation of Health and Human Services Secretary Robert F. Kennedy Jr. Trump has endorsed a candidate trying to unseat the Louisiana Republican, which could complicate that effort.
