Marty Makary resigns as FDA commissioner following industry and White House backlash

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 the top food official at the FDA, will step in as acting commissioner. In earlier remarks to reporters, Trump called Makary a "wonderful man" and said "He's going to go on, and he's going to lead a good life."

Trump shared a second post that showed a purported resignation text from Makary. In the message, Makary touted his role in the FDA's priority review process that sped up some drug approvals, among other changes to the agency.

A senior administration official confirmed that Makary resigned on Tuesday, following days of reporting that the White House was planning 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 nominee to replace Makary in the coming weeks, though the official cautioned it's too early to name potential replacements.

Makary, a surgical oncologist known for criticizing the government's handling 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 leadership turmoil at the FDA, along with mounting backlash from drugmakers, physicians and patient groups on regulatory decisions, including high-profile rejections of some rare disease treatments. At the same time, the White House reportedly grew increasingly impatient with what it viewed as his slow movement on Trump's key policy initiatives, such as legalizing 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 reportedly slow-walked a safety review of the pill, which can be mailed to states that have limited abortion. Makary's successor will inherit that review and the tricky politics associated with abortion.

The senior administration official said they couldn't point to one issue that led to Makary's ouster, but said it was a buildup of many problems. Abortion was one of those issues.

Despite the controversy around recent drug rejections, the pharmaceutical industry appears wary about a shakeup at the top of the FDA. The pharmaceutical industry is negotiating the reauthorization of the Prescription Drug User Act Fee, which outlines the fees the FDA collects from drugmakers to fund its reviews.

Staff morale at the agency had plummeted after layoffs and departures of career agency scientists, including longtime cancer regulator Dr. Richard Pazdur, who cited Makary's leadership as his reason for leaving. Meanwhile, distrust of leadership has reportedly grown among the staff that remained. 

Among Makary's most polarizing appointees was Vinay Prasad, who served as a key agency official overseeing vaccines and biotech treatments before stepping down at the end of April. Prasad, an outspoken academic and podcaster, left the agency after mounting criticism of the FDA within the biotech and pharmaceutical industries and among former health officials.

For example, the FDA initially refused to review Moderna's flu shot – a decision that the biotech company said was inconsistent with previous agency guidance and specifically stemmed from Prasad. The FDA later reversed course on the vaccine.

Prasad also faced backlash earlier this year for his rejection of a Huntington's disease gene therapy from uniQure, which claimed the FDA was requiring it to perform fake brain surgery to evaluate whether the treatment works. In a CNBC interview in March, Makary appeared to criticize that treatment without naming it. 

In April, the FDA rejected Replimune's drug candidate for melanoma a 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 three independent teams have arrived at the same conclusion around the drug and that the FDA has not made "corrupt sweetheart deals."

"I don't work for Replimune, I work for the American people, and I stand by the scientists at the FDA,"  Makary said in the interview with CNBC's David Faber. 

In March, Sen. Ron Johnson, R-Wisc., announced an investigation into the FDA's rejection of rare disease treatments.

In order to install a new commissioner, Trump will likely need to secure support from Sen. Bill Cassidy, a former physician who nearly blocked the confirmation of Health and Human Services Secretary Robert F. Kennedy Jr. Trump has backed a candidate trying to unseat the Republican from Louisiana, which could complicate that effort.