Dr. Marty Makary is no longer the commissioner of the Food and Drug Administration, President Donald Trump said on May 12.
Makary's deputy "is taking over temporarily," Trump told reporters outside the White House in Washington.
Makary "was having some difficulty, but he's going to go on and he's going to do well," the president added later.
Trump declined to say whether Makary resigned or was fired.
The FDA and the White House did not immediately respond to requests for comment.
Makary was sworn in on April 1, 2025, after being confirmed by the Senate.
Before joining the administration, he was a cancer surgeon at Johns Hopkins University School of Medicine and a professor at the Johns Hopkins Carey Business School. His books and articles include "Unaccountable—What Hospitals Tell You and How Transparency Can Revolutionize Health Care.”
Makary's resignation was preceded by the departure of Dr. Vinay Prasad as the FDA's top vaccine official. Prasad, who left the government in 2025 before coming back shortly thereafter, and Makary are close friends.
Makary had faced criticism from companies, lobbyists, and others for agency officials declining to approve certain drugs, including a cancer drug made by Replimune. Makary had defended the decisions in television interviews as following the evidence.
Some Republicans had also taken issue with the FDA's review of mifepristone, an abortion drug.
Sen. Josh Hawley (R-Mo.) said on X on Tuesday that Makary's exit was "welcome news" in part because he "slow walked a vitally necessary review of the abortion drug mifepristone."
Trump has seen some of his health nominees stall in the Senate, including his pick for surgeon general, Dr. Casey Means. Trump recently announced he was withdrawing the nomination and selecting Dr. Nicole Saphier as the new nominee.
Sen. Bill Cassidy (R-La.), a doctor who chairs the Senate Health Committee, which performs the initial vetting and chooses whether to advance health nominees, has clashed with Health Secretary Robert F. Kennedy Jr. over vaccines. Cassidy faces a contested primary in Louisiana on Saturday, with polls placing him in second or third place.
The Senate committee has also not moved yet on the nomination of Dr. Erica Schwartz to be the director of the Centers for Disease Control and Prevention. The panel, and the full Senate, in 2025 confirmed Trump's first CDC director nominee, Susan Monarez, only for the president to fire her after about a month following a rift between Monarez and Kennedy.
