Trump Reportedly Plans to Fire FDA Commissioner Marty Makary After Tumultuous Year

President Trump has reportedly signed off on a plan to dismiss FDA Commissioner Marty Makary after a turbulent year at the agency, according to multiple outlets including The Wall Street Journal and Bloomberg . Insiders cautioned the decision could still change, but the reporting represents the most concrete signal yet of Makary's pending exit.

The agency has been buffeted by DOGE-driven staff cuts, internal personnel drama, and a series of high-profile decisions on vaccine approvals, gene therapy, the abortion pill, and vape regulation . The Washington Post added that no acting director has been selected, leaving open who would steer the agency's near-term review docket .

For biotech and pharma investors, leadership uncertainty at the FDA is a tangible risk to PDUFA timing, advisory committee posture, and post-market enforcement priorities. Names with near-term approval catalysts, particularly in vaccines and gene therapy, face the most direct exposure. Watch for the named successor, any signals on the agency's review priorities, and whether large-cap biopharma issues guidance commentary on regulatory cadence.