The fate of FDA Commissioner Marty Makary, MD, remained unclear May 11 after multiple news outlets reported May 8 that President Donald Trump had signed off on a plan to oust him — reports the president publicly waved off the same day.
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. Since his appointment, he has 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.
Leadership turnover at the FDA could affect drug approvals, food safety oversight and tobacco regulation. The agency 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.
Five things to know:
1. The Wall Street Journal reported May 8 that President Trump approved a plan to remove Dr. Makary, though the news outlet noted the decision was not final and could still change.
2. Dr. Makary did not respond to the Journal’s request for comment. When asked about Dr. Makary’s possible exit on May 8, President Trump told CNN, “I’ve been reading about it, but I know nothing about it.”
“President Trump has assembled the most experienced and talented administration in history, an administration that continues to focus on delivering more historic victories for the American people,” White House spokesperson Kush Desai told the Journal.
3. A White House official told Politico that senior HHS leaders — not the White House — have been driving the push to remove Dr. Makary, according to a May 8 report.
4. Reporting from the Journal and other outlets, like 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.
5. If Dr. Makary’s exits, he would follow other senior leadership departures under HHS Secretary Robert F. Kennedy Jr., including the resignation of HHS Deputy Secretary Jim O’Neill in February and the ouster of CDC Director Susan Monarez, PhD, in August. Four other CDC leaders resigned in August following Dr. Monarez’s exit.
Becker’s has reached out to the HHS for comment and will update this story if more information becomes available.
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