Donald Trump has reportedly signed off on firing FDA Commissioner Marty Makary, according to the Wall Street Journal, because nothing says "public health" like a revolving door at the agency responsible for ensuring your medicine won't kill you. Makary's tenure has been a masterclass in controversy, featuring decisions on abortion, drugs, and vaping that have left staff morale lower than a snake's belly in a wagon rut. The White House and Republican lawmakers have been gunning for him after a series of high-profile moves, including pulling back publications on shingles and Covid vaccine safety, and a pivot from two clinical trials to one - because why be thorough when you can be fast?
Makary is reportedly "on thin ice" with the White House, with Bloomberg News noting he's "one more high-profile misstep" from unemployment. Trump personally "upbraided" Makary over fruit-flavored vapes, which were approved on Tuesday as part of a plan to woo younger voters - because nothing says "healthy future" like candy-flavored nicotine. Experts warn that political interference, or even the appearance of it, is a bigger risk than vaping itself. Peter Lurie, a former FDA associate commissioner, noted that trust built over decades can be destroyed in months, and the agency has managed to do just that with "unpredictable practices and general chaos."
FDA officials reportedly stopped research on shingles and Covid vaccine safety, with a study showing "the benefits of vaccination outweigh the risks" pulled by top vaccines regulator Vinay Prasad. Angela Rasmussen, a virologist and co-editor of the journal Vaccine, called this "the tip of the iceberg" and declared the FDA "a complete mess." The agency may be testing how much it can get away with administratively, since most people find it "incredibly boring" - until millions lose access to a drug or vaccine they need.
Makary has also been a headache for the White House over decisions like rejecting a melanoma treatment from Replimune, prompting the Wall Street Journal to run nine opinion pieces begging for approval. Makary fired back, saying he works for the American people, not Replimune. Senator Ron Johnson is investigating FDA rejections of rare disease treatments, while Representative Darin LaHood claims mismanagement has "chilled investments" in cures. HHS Secretary Robert F. Kennedy Jr. defended Makary, blaming "the industry" for owning Congress and the media.
Abortion has been another flashpoint, with Republicans demanding action on mifepristone. Senator Josh Hawley introduced a bill to remove FDA approval of the medication entirely. Meanwhile, a revolving door of directors at the Center for Drug Evaluation and Research (CDER) has left staff reeling. George Tidmarsh was ousted and sued; Richard Pazdur quit after a month. The current acting director, Tracy Beth Høeg, is a sports medicine physician with "no expertise," critics say. At the Center for Biologics Evaluation and Research (CBER), Vinay Prasad was fired, rehired, and departed again at the end of April, after overruling scientists on Covid vaccines and Moderna's new flu vaccine - which, ironically, works better for people over 50, according to new research.
Makary, a former Johns Hopkins surgeon who rose to fame by critiquing Covid boosters, has also promoted conspiracy theories, suggesting HIV came from a lab and Lyme disease from a secret military lab - claims debunked by science. He spoke at an HHS conference on women's health, criticizing c-sections and antibiotics while invoking his own son, who "is not getting antibiotics unless he's on his deathbed or suffering." Rasmussen warned that the agency's chaos could lead to deaths: "It's just a matter of time before the wrong thing gets approved or before the right thing doesn't get approved."