Trump has signed off on ousting FDA chief, senior official says

By Adam Cancryn, Sarah Owermohle, Meg Tirrell, CNN

(CNN) — President Donald Trump has signed off on a plan to oust US Food and Drug Administration Commissioner Dr. Marty Makary, according to a senior administration official.

The decision follows mounting criticism from both Trump aides and outside allies over Makary’s management of the health agency, controversial drug approval decisions and handling of an effort to further limit access to the abortion pill mifepristone.

Trump has not yet formally dismissed Makary, and the official and others familiar with the situation cautioned that the president could always change his mind.

Notably, senior White House staffers are scheduled to meet with anti-abortion activists Friday evening who have sharply criticized both Makary and Trump personally over a lack of action on restricting mifepristone.

Trump and other aides have increasingly discussed the prospect of removing Makary in recent weeks, including surveying outside allies about his job performance and fielding complaints about the agency from pharmaceutical industry officials and anti-abortion groups.

Spokespeople for the White House and the US Department of Health and Human Services did not respond to requests for comment. The Wall Street Journal first reported the plan to remove Makary.

Should Trump follow through on firing Makary, it would create yet another vacancy at the top ranks of the health department with just months to go until the midterm elections.

The department already lacks a permanent director of the US Centers for Disease Control and Prevention and a surgeon general. The FDA is also still without a top vaccine regulator following the recent departure of Dr. Vinay Prasad, a close Makary ally who faced separate criticism over his leadership and vaccine policy decisions.

In a sign of turbulence within HHS, one of the complicating factors in the plan to dismiss Makary on Friday remained deciding who would replace him atop the FDA, people familiar with the situation said.

Mounting pressure

Makary, a surgeon and author, had pledged to accelerate FDA decisions on drugs, devices and vaccines following his confirmation last March. But he frequently found himself mired in controversy over the subsequent year — criticized by both pharmaceutical companies unhappy with his management of the drug approval process and administration officials who questioned his handling of other areas of FDA’s sweeping portfolio, including tobacco regulation.

In a recent flashpoint that renewed talk among Trump and his advisers about firing Makary, the FDA chief resisted internal efforts to approve the sale of fruit-flavored e-cigarettes. The issue prompted an angry Trump to directly press Makary over the vapes decisions, two people familiar with the episode said. The FDA subsequently reversed course on flavored e-cigarettes this week.

“It’s frustrating because President Trump, during his first term, said that he wanted to move forward with approving these products, and we didn’t see that happen,” said David Williams, president of the Taxpayers Protection Alliance.

He mused that FDA’s reversal may have been “a way to appease Trump, rather than what (Makary) really believes for vaping.”

Speculation surrounding Makary’s job security built up over weeks of public pressure from various corners of Trump’s coalition who argued the administration was not living up to campaign promises.

One of those major cohorts is the anti-abortion activists meeting with White House officials on Friday. They’ve pushed for the FDA to reverse regulations that allow providers to send the abortion pill mifepristone through the mail.

Such a move would have repercussions across the country for abortion access, as the FDA sets the nationwide rules for prescribing the drug. Medication abortion now accounts for roughly two-thirds of all US abortions and has helped fuel an overall increase in abortions since the US Supreme Court ended nationwide protections for abortion rights in 2023.

Social conservatives had warned for months that it could be a motivating issue in the upcoming midterm elections — and that part of the blame rested on Makary.

“FDA Commissioner Makary should be fired immediately,” Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said in a statement days before the White House meeting, which she was planning to attend. “Indifference is completely unacceptable to millions of pro-life voters expecting the administration to act to save lives.”

The Supreme Court could now preempt any FDA decision. The court is expected to decide within days whether it will take up a Louisiana case arguing that mail orders of the abortion pills undermine its state laws, which ban abortion.

A divided base

The constant furor surrounding Makary has contributed to an overall sense of exhaustion among some aides, who came to view him as too much of a distraction in a critical midterm year, people familiar with the internal discussions said.

While Makary retained a handful of strong allies at the White House, many aides have grown increasingly dissatisfied with his management of an agency that they viewed as constantly in chaos.

The FDA commissioner has also divided the “Make America Healthy Again” coalition sparked by HHS Secretary Robert F. Kennedy Jr. Some vaccine critics have lamented that Makary has not pulled Covid-19 vaccines off the market. Others, advocating for improved food policies, have praised him for taking steps to remove artificial food dyes and crack down on ultraprocessed foods.

“We love [Dr. Makary],” Alex Clark, a Turning Point USA podcaster and influential MAHA advocate, wrote on X Friday, alongside a picture of the two in the FDA room Makary often uses to tape his podcast, “FDA Direct.”

Industry turmoil

Still others see Makary as too friendly to the biotechnology industry, even as the FDA under his leadership has at times frustrated drug developers with perceived reversals in its guidance and review process for new medicines.

In February, the agency first refused to review an application from Moderna for an mRNA vaccine against seasonal flu, then changed course days later. A Moderna executive told CNN the initial move was inconsistent with previous feedback, calling the refusal a “complete stunner.”

In March, biotech company uniQure said the agency asked for an additional clinical trial of an experimental gene therapy for the fatal neurodegenerative disorder Huntington’s disease, dashing hopes of patients and advocates who’d hoped for a faster path to approval. The FDA then held an unusual call with reporters defending its decision, calling the medicine a “failed therapy.”

The FDA has also been criticized for moves on rare disease drugs from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals, Regenxbio and others, and a melanoma drug from Replimune. Makary in particular, along with his controversial former vaccine chief Prasad, has been a target of a flurry of critical editorials from the Wall Street Journal.

Nevertheless, Makary over the last week had insisted to associates that his job remained secure, telling them that Trump had indicated he was safe despite the confrontation over flavored vapes, according to people who spoke with him. On Friday, Makary was privately dismissing the reports of his imminent ouster as false, those people said.

Still, amid the rising scrutiny, some came away from those conversations skeptical that he would ultimately survive.

“He’s not in good shape,” said one of those people. “He’s still putting on a good face, but I think it’s just a matter of time.”

Tierney Sneed contributed to this report.

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