If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.
President Donald Trump has reportedly signed off on a plan to fire FDA Commissioner Marty Makary, who has overseen a tumultuous period at the agency defined by unexpected drug rejections, staff departures and reported infighting among leadership.
The news, reported by The Wall Street Journal Friday afternoon, citing “people familiar with the matter,” comes after Makary defended one of those controversial rejections—that of Replimune’s advanced melanoma therapy RP1—in a heated interview with CNBC on Tuesday. Other unexpected rejections during the past year include Capricor Therapeutics’ deramiocel for Duchenne muscular dystrophy cardiomyopathy last summer, and Disc Medicine’s rare disease drug bitopertin, which was awarded a Commissioner’s National Priority Voucher (CNPV) in October 2025.
Makary took over the FDA leadership role on March 25, 2025, after congressional confirmation. He previously served as a surgical oncologist at Johns Hopkins University School of Medicine.
While he was head of the agency, Makary often faded into the background behind larger personalities, such as Center for Biologics Evaluation and Research Director Vinay Prasad. Prasad left the FDA on April 30 at the end of an apparently planned one-year leave of absence from the University of California, with Katherine Szarama put in his place as acting director—the fifth leader of CBER in less than 18 months.
Makary also came under fire after the FDA refused in February to review an application for Moderna’s mRNA-based flu vaccine. Makary was called to the White House and Trump “expressed frustration” to Makary over how the agency is handling vaccine issues, Politico reported at the time, citing two people privy to details about the meeting. The FDA accepted an amended application for the vaccine a week later.
Trump’s plan is not final and could change, WSJ noted.
“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 spokesman Kush Desai told the publication.
BioSpace has reached out for independent confirmation.
One of Makary’s more controversial ideas is the Commissioner’s National Priority Voucher (CNPV) program, which is meant to grant swift reviews to hand-selected therapies. The program, however, has been met with legality concerns. Questions were also raised about the efficacy of the scheme in February after bitopertin was rejected.
Veteran regulator Richard Pazdur pointed to pressure from Makary as one of the concerns that led to his resignation as head of the FDA’s Center for Drug Evaluation and Research in December 2025.
Pazdur has since spoken out about his experience, claiming that the “wall between the commissioner’s office and the review staff has been breached” under Makary’s leadership.
Makary was a frequent figurehead at the White House as President Donald Trump announced policies related to health or drug pricing. He attended the Most Favored Nation drug pricing announcements in the fall as major pharmaceutical companies, including Pfizer, Eli Lilly and Novo Nordisk reached agreements to lower prices for some of their medicines.
In November 2025, reports emerged that the Trump administration was considering limiting Makary’s role or replacing him entirely. He seems to have survived that review until now.
