The White House has approved a plan to fire FDA Commissioner Marty Makary, according to reporting Friday, capping months of escalating tension over contentious regulatory decisions and internal chaos that have eroded public confidence in the nation's premier drug safety watchdog.
Makary's position has become increasingly precarious following a string of high-profile moves that angered both the administration and Republican lawmakers. The latest flashpoint came when Trump personally pressured Makary over the weekend to approve fruit-flavored vapes after the commissioner initially blocked them. Makary relented, and the vapes were approved Tuesday, with the official announcement conspicuously crediting "President Trump's leadership" rather than any FDA recommendation.
The decision reflected a broader pattern: regulatory choices driven by political considerations rather than scientific evidence. Vakota experts warn that such interference carries profound long-term consequences. Peter Lurie, a former FDA associate commissioner and executive director of the Center for Science in the Public Interest, put it starkly. "Public trust is built up not over months, but over decades," Lurie said. "On the other hand, you can destroy it in mere months. In a very short period of time, they have managed to undermine years of trust that the agency has built up with the public and industry because of their unpredictable practices and the general chaos."
The FDA's retreat on vaccine safety research has triggered particularly sharp backlash. Agency officials halted publication of studies examining the safety profiles of shingles and COVID-19 vaccines. The COVID vaccine research, which had been accepted for publication in the journal Vaccine, concluded that "the benefits of vaccination outweigh the risks." Angela Rasmussen, the journal's co-editor and a virologist at the University of Saskatchewan, expressed alarm at what she sees as systematic top-level suppression of research. "I think we're going to start seeing a big pattern of this," she said. "It just seems like this is the tip of the iceberg, and the FDA is just a complete mess."
Vinay Prasad, the nation's top vaccines regulator, ordered the COVID vaccine study withdrawn. Prasad, who has clashed repeatedly with agency scientists and has been fired and rehired, was instrumental in crafting a new vaccine approval framework announced via journal article rather than through standard agency channels. He has also overruled center scientists on other vaccine decisions and briefly blocked Moderna's new flu vaccine, which research shows works better than conventional options for people over 50.
Internal turmoil has compounded the damage. The FDA's Center for Drug Evaluation and Research (CDER) has cycled through multiple directors in rapid succession. A biotech veteran was hired, then ousted after allegations he used his position to influence company business decisions. A respected cancer drug regulator accepted the role, then quit after a month. The current acting director, Tracy Beth Hoeg, is a sports medicine physician with no relevant expertise, according to critics.
Layoffs and the appointment of inexperienced officials have gutted staff morale. Lurie described the environment as "endless chaos," with constant personnel upheaval creating a "massive upheaval that has been an ongoing feature of daily work at FDA ever since the new administration began."
A new program allowing one-day regulatory decisions through a "commissioner's priority voucher" has drawn sharp criticism. Rasmussen warned of inevitable consequences. "It's just a matter of time before the wrong thing gets approved or before the right thing doesn't get approved, and people die as a result," she said.
Republican lawmakers have weaponized regulatory disputes. Senator Ron Johnson opened an investigation into FDA rejections of rare disease treatments. Representative Darin LaHood cited "mismanagement and bungled drug reviews" that have allegedly chilled investment in life-saving cures, allowing international competitors like China to gain ground. Meanwhile, some Republicans have demanded action on mifepristone, the abortion medication, with Senator Josh Hawley introducing legislation in March to revoke FDA approval entirely.
Makary, a Johns Hopkins surgeon who gained prominence by critiquing COVID boosters, has also promoted unfounded conspiracy theories about disease origins. He has suggested HIV likely came from a laboratory and claimed Lyme disease "very well may" have originated from a secret military lab on Plum Island, contradicting scientific consensus that the bacteria circulated long before that facility existed.
At an HHS health conference in March, Makary criticized cesarean sections and antibiotics as disruptions to the microbiome, saying his own young son was "lucky he did not need a c-section" and will avoid antibiotics "unless he's on his deathbed."
Makary has pushed back on suggestions that industry lobbying drives FDA decisions. When confronted about repeated Wall Street Journal opinion pieces demanding approval of a melanoma treatment from drugmaker Replimune, which the FDA rejected, Makary told CNBC, "I don't work for Replimune, I work for the American people, and I stand by the scientists at the FDA." HHS Secretary Robert F. Kennedy Jr. has defended both the FDA and Makary, arguing that industry power in Congress and media explains why the commissioner faces constant attacks.
The chaos has already damaged regulatory credibility. Rasmussen noted that the FDA can quietly implement consequential decisions that few members of the public follow closely. "While the FDA is 'incredibly boring' to many members of the public, it's also 'really powerful from a regulatory perspective,' she said. "So you could do something totally boring that nobody pays attention to and, boom, millions of people don't have access to a drug or vaccine that they need."
Trump's plan to remove Makary has not yet been finalized and could still change, though multiple sources describe the commissioner as operating on "thin ice" with the White House and being "one more high-profile misstep" away from termination.
Author James Rodriguez: "The FDA's collapse from a trusted regulator into a political instrument is happening at breathtaking speed, and Makary's likely removal won't fix what's broken if the underlying political interference continues."
Comments