Dr. Marty Makary is out as FDA commissioner, President Donald Trump said Tuesday, ending a controversial tenure at the health agency.
Makary is “a wonderful man and he’s going to leave, and the assistant, the deputy, is going to take over temporarily,” Trump told reporters on Tuesday.
He added, “He will go on, and he will live a good life.”
Multiple media outlets reported that Makary resigned on Tuesday, days after reports that the White House was planning to fire him.
Kyle Diamantas, who previously served as the FDA’s chief food officer, will step in as acting commissioner, according to reports. Trump on Tuesday did not mention Diamantas by name.
Makary, a surgeon known for criticizing the government’s handling of the Covid pandemic, has served as head of the agency responsible for controlling food, drugs and medical devices for more than a year.
His tenure was marked by internal dysfunction and leadership turmoil at the FDA, as well as an outpouring of backlash from drugmakers, doctors and patient groups over regulatory decisions, including high-profile rejection of alternative treatments for rare diseases. At the same time, the White House reportedly grew impatient with what it viewed as Trump’s slowness on key policy initiatives, such as legalizing flavored vapes.
Susan B. Anthony’s powerful organization Pro-Life America also called for Makary’s ouster over the FDA’s handling of the abortion pill mifepristone. Makary reportedly went slow in testing the safety of the pill, which can be shipped to states with abortion restrictions. Makary’s successor will inherit that review and the sleazy politics surrounding abortion.
Despite the controversy over recent drug rejections, the pharmaceutical industry seems wary of the FDA’s high-profile shakeup. The pharmaceutical industry is negotiating the reauthorization of the Drug User Fee Act, which outlines the fees the FDA collects from drugmakers to fund its reviews.
Makary touted his accomplishments as commissioner, including his flagship voucher program that expedited review times for certain drugs.
But staff morale at the agency has plummeted after layoffs and departures of the agency’s scientists, including longtime cancer director Dr. Richard Pazdur, who cited Makary’s leadership as the reason for his departure. Meanwhile, it is reported that the distrust of the leadership among the remaining workers has increased.
Among Makary’s most divisive appointees was Vinay Prasad, who served as the agency’s top official in charge of vaccines and biotech therapies before stepping down at the end of April. Prasad, an outspoken academic and podcaster, left the agency after being heavily criticized by the FDA in the biotech and pharmaceutical industries and among former health officials.
For example, the FDA initially refused to review Moderna’s flu shot — a decision the biotech company said was inconsistent with the agency’s previous guidance and stemmed from Prasad. The FDA later withdrew the vaccine.
Prasad also faced backlash earlier this year for his rejection of a gene therapy for Huntington’s disease from uniQure, saying the FDA required him to perform mock brain surgery to test the treatment’s effectiveness. In a CNBC interview in March, Makary appeared to criticize that treatment without naming it.
In April, the FDA rejected Replimune’s melanoma drug candidate for the second time after the initial rejection in July. The agency cited insufficient evidence of efficacy and objected to the single-arm trial design.
In an interview with CNBC in May, Makary said three independent groups reached the same conclusion about the drug and that the FDA did not make “rogue sweetheart deals.”
“I don’t work for Replimune, I work for the American people, and I represent scientists at the FDA,” Makary said in an interview with CNBC’s David Faber.
In March, Sen. Ron Johnson, R-Wisc., announced an investigation into the FDA’s refusal to treat rare diseases.
To install a new commissioner, Trump will likely need to get support from Sen. Bill Cassidy, the former physician who nearly blocked the confirmation of Health and Human Services Secretary Robert F. Kennedy Jr.
