FDA Commissioner Marty Makary faces ouster after President Trump reportedly signed off on a plan to fire him, per a Wall Street Journal report Friday citing people familiar with the matter.
Makary has held the role since March 25, 2025. His 14 months featured a string of unexpected drug rejections: Replimune’s advanced melanoma therapy RP1, which Makary defended in a heated CNBC interview Tuesday; Capricor Therapeutics’ deramiocel for Duchenne muscular dystrophy cardiomyopathy; and Disc Medicine’s rare disease drug bitopertin.
The Moderna mRNA flu vaccine became a flashpoint in February. FDA initially refused to review the application, Trump called Makary to the White House and expressed frustration, and the agency accepted an amended application a week later.
Richard Pazdur, longtime head of FDA’s Center for Drug Evaluation and Research, resigned in December 2025 citing pressure from Makary’s office. He’s since said the “wall between the commissioner’s office and the review staff has been breached.” Vinay Prasad, the prominent CBER director, left April 30, making Katherine Szarama the fifth CBER head in under 18 months.
Makary’s CNPV program, designed to grant swift reviews to hand-selected therapies, drew legality concerns. Bitopertin held a CNPV award when it was rejected in February, calling the scheme’s efficacy into question.
The plan isn’t final and could change, WSJ cautioned.
Sarah Chen