Makary out as FDA commissioner

FDA Commissioner Marty Makary was ousted from his job today and replaced on an interim basis by Kyle Diamantas, J.D., who has served as the FDA’s deputy commissioner in charge of food regulation.

In impromptu remarks to reporters, President Donald Trump said Makary “had some difficulty” as FDA commissioner but praised him as a “great doctor” and “a wonderful man.”

Trump posted a message from Makary on Truth Social in which Makary, addressing Trump, said, “Please accept my resignation effective today.”

In that message, Makary said he had announced 50 major FDA reforms as the agency’s commissioner and listed the achievement he was proud of, which included the new guidance for psychedelics, the introduction of a “new plausible mechanism pathway” for rare disease drugs designed to speed their approval, and a change to the label for menopausal hormone replacement therapy that removed the prominent “boxed” warning about an association between hormone replacement therapy and cardiovascular disease, breast cancer and dementia

Diamantas was a partner at Jones Day, a conservative law firm, before taking the top food job at the FDA early last year. News report today had just a modicum of information about him. One account said that industry officials viewed him as “knowledgeable, pragmatic, and easier to work with compared to some recent FDA leaders.” But the National Catholic Register reported that some pro-life advocates are upset by Diamantas’ promotion, asserting that he had once served as counsel for Planned Parenthood of Greater Orlando.

Other outlets reported that some Trump officials may want to bring back Stephen Hahn, who served as FDA commissioner during Trump’s first term, or Brett Giroir, who became well-known as the “testing czar” of the first Trump’s COVID-19 task force.

Although stories by the Wall Street Journal and Bloomberg News (“Paranoia, Turmoil and Backlash: Inside the FDA Uner Marty Makary”) painted a bleak picture of Makary’s 13 months in charge of the FDA and suggested that the White House was losing patience with him, the ouster chapter of his tenure started to unfold in earnest on Friday when the Journal reported that Trump had signed off on his firing, although the newspaper and other outlets hedged their bets, reporting that Trump could change his mind. There was no more news about Makary’s ouster over the weekend or on Monday, and Makary was scheduled to testify before a Senate subcommittee tomorrow morning. The pause and FDA schedules that included Makary led to a small puff of speculation that Makary might, in the end, weather the storm and stay in charge of the FDA. Instead, Politico broke the news today that Makary was ousted, a report that kicked off a flurry of reports by other outlets with the same news that was losing his FDA job.

None of the news accounts of Makary’s ouster centered the explanation on a particular cause or incident. Instead, they painted a picture of series of events or decisions that alienated or angered interest groups or constituencies of various levels of importance to the Trump administration. Makary angered some antiabortion activists by not moving faster on a safety review of mifepristone, one of the two pills taken for medical abortions. They were also angry that the agency approved a generic form of mifepristone last year. Sen. Josh Hawley, a Missouri Republican, posted on X that Makary’s ouster was “welcome news” and that he was “uniquely destructive to the prolife movement.”

Makary also ran afoul of vaping and tobacco interests by holding up approval of fruit-flavored pods that some critics of the vaping say induce children to start using the nicotine product. Makary reportedly reversed course after pressure from Trump. The vaping industry says the fruit-flavored products are paired with an app-based technology designed to limit the use of the vaping products to adults.

Makary and Vinay Prasad, who served under Makary as director of the FDA’s Center for Biologics Evaluation and Research until leaving the FDA in April, also frustrated some biotech and rare disease interests. Drug companies with gene therapy product for Duchene muscular dystrophy, Huntington’s disease and Hunter syndrome complained about FDA decisions concerning safety and requirements for additional clinical trials. Makary and the FDA came under especially strong and persistent attack from the Wall Street Journal’s editorial page for not approving Replimune’s immunotherapy drug for advanced melanoma. The company said in an April 10 news release that data from the trial which earned its product breakthrough status was strong enough to merit approval, citing a 34% response rate. The FDA’s complete response letter — effectively, a rejection notice — says that trial was not designed to isolate the contribution of Replimune’s drug vusolimogene oderparepvec, when administered in combination with nivolumab and that the evidence supporting the drug needed to come from a trial with a control group.

In an interview with CNBC last week, Makary grew animated defending the decision about Replimune’s drug. “I don’t work for Replimune,” Makary said. “I work for the American people.”

Makary fall occurred despite his playing a substantive role in implementing the Trump administration’s most-favored-nation (MFN) drug pricing policies. Makary implemented a policy awarding priority review vouchers that were tied to the MFN deals that the administration has made with major drugmakers.

Staffing cuts and departures of senior officals at the FDA were another feature of Makary’s time at the FDA.

In a recent interview with Stat, Richard Pazdur, M.D., a 25-year veteran of the FDA and the founding director of its Oncology Center of Excellence, said, “I didn’t leave the FDA.The FDA left me.”

Pazdur, who left the agency late last year, said when he worked at the agency, there was a firewall between the political appointees and the staff that reviews applications for drug approvals.

“I really felt this wall was being breached by the political appointees on many levels,” Pazdur told Stat.