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Inside Marty Makary’s Downfall at the FDA

Senior administration officials concluded the commissioner was out of step with President Trump’s priorities

In the end, Dr. Marty Makary had just about run out of allies.

The chorus calling for the Food and Drug Administration commissioner to be ousted—from inside and outside the administration—grew so loud that White House chief of staff Susie Wiles went to President Trump last week to discuss the concerns about his leadership, according to people familiar with the matter. She had previously defended him and liked the former Johns Hopkins surgeon.

Earlier in the week, Wiles discussed with Chris Klomp, the No. 2 official at the Department of Health and Human Services, which houses the FDA, the reasons Makary had become a net liability for the administration, the people said.

Those conversations followed a decision made privately by Health and Human Services Secretary Robert F. Kennedy Jr., who around the end of April concluded he would need to replace Makary, the people said. Kennedy directed Klomp to lead the effort to find a replacement.

Makary’s downfall was cemented Tuesday when Trump announced Makary was leaving his role, capping a tumultuous 13-month run leading an agency that regulates about one-fifth of U.S. consumer spending. He had upset advocates for vaping and rare-disease patients, antiabortion groups, and some drug-industry leaders—as well as other officials in the administration.

Senior officials told Makary on Monday that they believed he needed to go, according to people familiar with the discussion. On Tuesday, the president posted on his Truth Social platform a screenshot of a text message that included Makary’s resignation. “It’s been the honor of a lifetime to serve as your FDA Commissioner,” Makary said. “I am forever grateful.”

White House spokesman Kush Desai said: “President Trump pledged to accelerate innovation in the United States, lower drug prices, and Make America Healthy Again. The FDA will continue to build on Commissioner Makary’s historic work delivering on these presidential priorities.”

Senior leaders in the White House increasingly concluded Makary was out of step with the president’s priorities on vaping and other policy issues, people familiar with the matter said. Pharmaceutical-industry insiders were coming to the White House with complaints, as executives from Massachusetts-based Replimune Group did last week, and some were calling for Makary’s removal. Even some of the people he had elevated to senior roles at his agency no longer trusted him, according to people familiar with the dynamics.

White House officials said they would repeatedly have to tell Makary what the president wanted done—and at times, the president would say it himself, “which wasn’t a good sign for him,” a senior administration official said.

One final battle emerged over the FDA’s handling of flavored vapes, which advisers told Trump were essential to retaining young MAGA voters. But Makary had overruled scientific staff at the FDA to stall authorization of blueberry- and mango-flavored vapes from an American manufacturer, concerned about public-health risks.

Executives from Reynolds American recently met with Trump at his Jupiter, Fla., golf course and complained about the FDA’s not approving vaping flavors, and Trump said it was a campaign promise he had made. On the campaign trail, Trump had called the Reynolds executives “my tobacco guys,” and they had attended a number of his fundraisers.

Over a lunch of cheeseburgers, Trump listened as the executives complained about Chinese vaping pens flowing into the country, and the FDA’s not approving flavored vapes, according to people familiar with the matter.

Trump said he had heard significant complaints from others in the administration and industry leaders about Makary, and complained that Makary hadn’t done enough to carry out his “Right to Try” legislation aimed at getting experimental therapies to terminally ill patients, the people said. Trump repeatedly brought up a cancer drug he said Makary wouldn’t approve, the people said.

He expressed frustration with his FDA commissioner and told the assembled group that he would handle the vaping issue. Phone calls were made to Kennedy, senior White House staff and Makary, who didn’t answer during the Jupiter meeting.

Trump later called Makary and pressured him to change course, which the agency did last week. Makary’s resignation came Tuesday, according to people familiar with his thinking, because he didn’t want to defend flavored vapes at a scheduled Senate hearing.

Makary was surprised by news reports last week that Trump intended to fire him, people familiar with his thinking said. He spent the weekend trying to determine his status, those people said. Allies came to his aid on social media. “Replacing Makary with a pharma puppet would move us backward, not forward,” MAHA influencer Alex Clark posted on X.

Makary’s nomination to lead the FDA in November 2024 was greeted with a sigh of relief from many agency employees, who were worried they would get a more-vocal vaccine skeptic in the vein of Kennedy.

Ahead of Trump’s second election to the White House, Makary had allied himself with the MAHA movement, criticizing Covid-19 vaccine mandates, the influence of “Big Pharma” and the failures of the modern medical establishment. But as a Johns Hopkins surgeon with traditional medical credentials, he has vaccine views that are generally more conventional than those of some others in the MAHA movement. Makary has recommended that eligible children get the measles vaccine, and he sailed through the Senate confirmation process.

Makary quickly became one of MAHA’s most-visible champions. In podcast interviews, TV appearances and on social media, he touted MAHA principles and his efforts to speed up drug reviews, incorporate artificial intelligence into the FDA’s work and approve natural food dyes.

He was sometimes a more-restrained voice on MAHA policy initiatives. After a viral press conference in September in which Trump urged pregnant women to avoid Tylenol, Makary penned a letter to doctors that offered a gentler warning, saying the painkiller in some studies had been associated with autism but hadn’t been proven to cause the condition.

Makary might have first begun irking Kennedy and the White House last summer. To mark his first 100 days in office, he debuted a FDA home page listing his accomplishments, accompanied by a large picture of himself. That irritated some in the administration, who viewed Makary as not giving enough credit to his bosses, people familiar with the matter said. Makary didn’t come up with the presentation for the webpage, according to a person familiar with his thinking.

Makary’s team would frequently bypass health department officials in making plans, with Makary telling subordinates not to communicate with HHS, people familiar with the matter said. He issued that order because he believed the health department was leaking information, people familiar with his thinking said.

Two of Makary’s early hires turned out to be gigantic headaches for him. Dr. Vinay Prasad, brought on by Makary to be vaccines chief at the FDA, was fired by the White House over the summer, only to be reinstated days later. His second departure this spring came after decisions opposed by some drugmakers working on rare diseases.

George Tidmarsh, Makary’s drugs chief, resigned after a former business associate accused him in a lawsuit of soliciting a bribe. He has denied any wrongdoing. His replacement lasted a few weeks.

Kennedy late last year became privately concerned about Makary’s ability to manage an agency of some 16,000 employees and considered making him a figurehead by installing someone else to run it. The secretary decided to give Makary a chance to turn it around.

Biotech companies in recent months voiced concern that Makary’s FDA was veering away from more-flexible standards for rare-disease drugs, which can be hard to test on limited numbers of patients.

“I don’t know how biotech works with the goalposts shifting,” said Replimune Chief Executive Sushil Patel in an April interview, who said his company’s melanoma drug received mixed messages from the FDA. Makary has said he went along with scientific staff’s conclusions on the company’s treatment.

Replimune representatives met last week with members of the White House Domestic Policy Council and argued that Makary was working against the Trump administration’s vision for drug policy, people familiar with the matter said.

Makary’s departure was effective Tuesday, and Trump said that Kyle Diamantas, the deputy commissioner for food, would take over leading the agency in an acting capacity. Makary left a day before he was slated to testify before the Senate.