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Trump plans to fire FDA's Makary after tumult at agency

Rachel Cohrs Zhang, Bloomberg News on

Published in News & Features

WASHINGTON — President Donald Trump plans to fire Food and Drug Administration Commissioner Marty Makary, following months of chaos at one of the country’s most important health agencies, according to a person familiar with the matter.

The president hasn’t yet dismissed Makary, the person said, asking not to be identified because discussions are private. The Trump administration is also mulling additional personnel changes at the FDA, according to people familiar with the deliberations.

Makary’s time as FDA commissioner has been marked by high employee turnover and friction with pharmaceutical companies. He has clashed with key conservative political figures over staffing, abortion pill access and other issues.

When asked by a reporter Friday if he was replacing Makary, Trump said no but didn’t elaborate.

“I’ve been reading about it, but I know nothing about it,” he said.

“President Trump has assembled the most experienced and talented administration in history, an administration that continues to focus on delivering more historic victories for the American people,” White House spokesman Kush Desai said in a statement.

The Department of Health and Human Services didn’t respond to requests for comment. When reached by phone Friday, Makary had no comment.

The FDA is tasked with ensuring that Americans’ food and medicines are safe. Since the second Trump administration began, most of the agency’s division leaders have either been fired or left. The FDA’s normally staid, scientific drug review process has become far more political during Trump’s second term.

Makary’s appointment was initially welcomed by leaders of the $1.7 trillion global pharmaceutical industry, who viewed the Johns Hopkins University surgeon and health policy expert as a more conventional choice than the outsiders and contrarians in Kennedy’s orbit.

However, during his tenure he’s regularly clashed with other officials in the administration. Those inside the FDA have described a culture rocked by staff clashes, leadership turmoil, industry backlash and a beleaguered, paranoid leader. Outside, drug companies say they’ve been blindsided by setbacks.

Some people familiar with the dynamics called the situation unsustainable recently, though Makary made efforts to right the ship. His controversial deputy Vinay Prasad exited the agency in April. Makary has also held meetings with biotech leaders and lawmakers, and he met with former commissioners to pick their brains.

 

For the last year, U.S. health officials have been forced to walk a fine line between Trump and Kennedy’s directions and the advice of scientific experts. Members of the administration and acolytes of Kennedy’s Make America Healthy Again movement have pushed the FDA and other health agencies to take a tougher stance on vaccines and a hodge podge of other well-established products they claim are harmful, including the over-the-counter painkiller Tylenol. On the flip side, Makary pushed to increase access to hormone replacement therapy for women, arguing that the treatments were unfairly stigmatized.

On Tuesday, however, a flurry of reports from major news outlets indicated more problems brewing. The Wall Street Journal reported that Trump had grown increasingly frustrated with Makary for not moving quickly enough to approve flavored vapes and nicotine products. Later that day, the FDA announced it was approving the products from Los Angeles-based manufacturer Glas.

Separately, The New York Times reported that the FDA had blocked publication of several studies supporting the safety of widely used vaccines. On Wednesday, a Stat report said the French drugmaker Sanofi SA requested its diabetes medication be pulled out of the agency’s priority voucher review program after a top Makary deputy disagreed with a staff decision to approve a new use of the drug.

On Friday, news of Trump’s plan to fire Makary was first reported by The Wall Street Journal.

Under Makary, the FDA has launched safety reviews of COVID 19 shots, targeted artificial dyes, cracked down on pharmaceutical advertising and started a program to speed up drug approvals for companies that are aligned with the Trump administration’s priorities.

However, he’s also run afoul of top conservative figures. Last year, the FDA slow-walked a promised review of safety data for the abortion drug mifepristone at Makary’s request to put it off until after the midterm elections, according to people familiar with the matter. That angered some Republican lawmakers and anti-abortion groups.

Cutting-edge biotech companies have also become disillusioned with Makary and what they describe as an inconsistent drug review process. Companies including Moderna Inc., UniQure NV and Replimune Group Inc. all said that setbacks in their review processes came as surprises.

Shares of UniQure rose 13% after news of Makary’s impending exit. The company has been in a dispute with the FDA over the future of its gene therapy for Huntington’s disease. Replimune, whose skin cancer treatment was recently rejected by the agency, jumped 16%.

(Jessica Nix, Courtney Subramanian, John Tozzi, Gerry Smith, Charles Gorrivan, Catherine Lucey and Jeff Mason contributed to this report.)


©2026 Bloomberg L.P. Visit bloomberg.com. Distributed by Tribune Content Agency, LLC.

 

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