FDA commissioner is out: 8 things to know

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FDA Commissioner Marty Makary, MD, has resigned from his role, President Donald Trump confirmed in a May 12 Truth Social post.

Eight things to know:

1. The post included a screenshot of a text message exchange between the two leaders, in which Dr. Makary gave his resignation, effective immediately. In the text, Dr. Makary said he announced 50 major FDA reforms during his tenure, reduced drug review times from a year to one to two months and established new guidance to “advance psychedelics.”

“It’s been the honor of a lifetime to serve as your FDA Commissioner,” the text message reads. “I am forever grateful.”

2. Kyle Diamantas, deputy commissioner for food, will be put in an acting position, President Trump said in a separate May 12 Truth Social post. He thanked Dr. Makary for “having done a great job at the FDA.”

“So much was accomplished under his leadership,” he said. “He was a hard worker, who was respected by all, and will go on to have an outstanding career in Medicine.”

3. The move comes after multiple May 8 reports that the president had signed off on a plan to fire Dr. Makary, which he publicly waved off the same day.

4. Reporting from the The Wall Street Journal and other outlets, such as The New York Times, pointed to clashes with health department officials and, at times, the White House over flavored vape authorizations, abortion pill policy and rare-disease drug reviews. The Journal reported Dr. Makary has also faced criticism from biotech companies, patients and advocacy groups. Most recently, Dr. Makary reversed course and authorized blueberry and mango vape flavors from manufacturer Glas after initially refusing in February and receiving pressure from President Trump, according to the Journal.

5. An administration official told Politico that Dr. Makary resigned, but HHS Secretary Robert F. Kennedy Jr. made the call, which the White House signed off on, according to a May 12 report. The official confirmed the acting role appointment for Mr. Diamantas, before it was confirmed by President Trump in the post.

6. Dr. Makary was confirmed as commissioner in March 2025. He previously served as a surgical oncologist and chief of islet transplant surgery at Johns Hopkins University School of Medicine in Baltimore. During his tenure, he focused on progressing the FDA’s national priority review voucher program, which aims to shorten drug review timelines, and opening a new approval pathway for individualized therapies targeting ultra-rare diseases.

7. Leadership turnover at the FDA — which regulates products accounting for 20 cents of every dollar spent by U.S. consumers and employs more than 18,000 people across the country and abroad — could affect drug approvals, food safety oversight and tobacco regulation. 

8. Dr. Makary’s exit follows other senior leadership departures under Mr. Kennedy, including the resignation of HHS Deputy Secretary Jim O’Neill in February and the ouster of CDC Director Susan Monarez, PhD, in August.

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