• FDA Commissioner Marty Makary is expected to resign as early as Tuesday, according to people familiar with the matter.
  • The White House has authorized the move, with President Trump's sign-off, and John Diamantas is poised to serve as acting commissioner.
  • The leadership change signals potential shifts in FDA regulatory tone, affecting drug approvals and biotech investor sentiment.

A Sudden Departure

FDA Commissioner Marty Makary is expected to resign on Tuesday, according to people familiar with the matter, in a move that has been in the works for weeks. The White House and the Department of Health and Human Services have been coordinating the transition, with President Trump signing off on Makary's exit. John Diamantas, a senior FDA official, is expected to take over as acting commissioner, the sources said.

The departure comes amid ongoing tension between the White House and the FDA over regulatory priorities and political influence on scientific decisions. Makary, who was appointed in April 2025, had pushed for faster drug approvals and greater transparency but faced criticism from some administration officials for not moving aggressively enough on certain policy changes.

Reached for comment, an FDA spokesperson declined to confirm the resignation, saying only that “Commissioner Makary continues to lead the agency.” The White House did not respond to requests for comment.

Industry Impact

The news sent ripples through the biotech sector, with the SPDR S&P Biotech ETF (XBI) (XBI) falling 1.2% in afternoon trading. Analysts say a leadership change could create near-term uncertainty for drug approval timelines and regulatory guidance. “An acting commissioner may slow down some review processes until a permanent replacement is named,” said a healthcare policy analyst who asked not to be named because they were not authorized to speak publicly.

Diamantas, if installed as acting commissioner, is expected to emphasize central coordination across FDA centers, potentially smoothing certain approval pathways but raising questions about consistency with prior policy signals. Investors are watching closely for any shifts in the agency's stance on accelerated approvals or post-market surveillance.

Political Context

Makary's ouster is the latest in a series of leadership changes across the FDA, following the departure of the head of the Center for Drug Evaluation and Research last month. The moves have sparked debate over the balance of power between political appointees and career scientists. Some lawmakers have expressed concern about political interference in regulatory decisions, while others argue the agency needs stronger oversight.

Without a permanent commissioner, the FDA’s ability to issue new guidance or finalize pending rules could be hampered. “The agency can still operate, but major policy initiatives often stall under acting leadership,” said a former FDA official.

Correction: An earlier version of this article incorrectly stated that Makary's resignation was expected on Monday. It has been updated to reflect Tuesday.