Dr. Marty Makary is expected to resign as commissioner of the Food and Drug Administration Tuesday, according to a federal health official familiar with management of the agency but who wasn’t authorized to speak publicly.

President Trump spoke at the White House about the expected FDA leadership change in remarks as he was preparing to leave on his trip to meet China’s President Xi Jinping.

“Marty is a great guy. He’s a friend of mine. He’s a wonderful man, and he’s going to be off and the assistant, the deputy, is taking over temporarily,” Trump said. “He was having some difficulty, you know, he’s a great doctor, and he was having some difficulty. But he’s going to go on and he’s going to do well.”

“It came down to the fruit-flavored vape issue,” the person with knowledge of the situation said, referring to pressure on Makary from the White House to authorize the sales of flavored e-cigarettes earlier this month. “He is at peace with the decision [to leave]. And he’s in good spirits, I would say.”

Makary’s resignation would end a tumultuous 13-month tenure at the agency. At times he angered the Make America Healthy Again movement galvanized by Health Secretary Robert F. Kennedy Jr., who is Makary’s boss, for not advancing its agenda quickly enough. He also upset people looking for a more traditional approach to regulation by the FDA as they knew it before Trump was elected for a second term.

Makary upset some in the MAHA movement when the agency approved updated mRNA vaccines against COVID-19, and has disappointed those who oppose abortion by approving a second generic version of mifepristone and not completing a promised safety review of the medicine.

Before joining the Trump Administration, Makary was a surgeon and health policy researcher at Johns Hopkins University School of Medicine. During the COVID pandemic, he was critical of vaccine policy and the Biden administration’s response.

The Senate confirmed Makary as FDA commissioner on March 25, 2025, just a week before mass firings by the Department of Government Efficiency, or DOGE, left hundreds of positions at the regulator vacant.

Makary aimed to streamline what he perceived as inefficiencies at the agency, for example by consolidating multiple voluntary reporting systems for drug, device and vaccine side effects, injuries and deaths.

But at times his own priorities as commissioner seemed to clash with one another. For example, he pushed for single pivotal clinical trials instead of the usual two to speed up the drug approval process, but under his leadership the agency also requested additional studies from companies seeking approval.

After Makary’s FDA refused to accept an application for Moderna’s mRNA flu shot earlier this year, citing a control arm in a study, the pharmaceutical industry questioned whether it could depend on the regulatory predictability that had characterized the agency for decades. Days later, the agency reversed course and accepted the application after all.

The U-turn followed other denials under Makary’s director for the agency’s Center for Biologics Evaluation and Research, Dr. Vinay Prasad, prompting frustration from the rare disease community, as STAT News has reported.

Makary was also at the helm when the agency removed longstanding warnings on certain hormone replacement therapy products without going through the usual process of hosting an advisory committee, which he called “bureaucratic, long, often conflicted and very expensive” at the time.

News Source : https://www.opb.org/article/2026/05/12/fda-commissioner-makary-expected-to-resign-after-tumultuous-tenure/