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President Donald Trump has reportedly approved a plan to remove U.S. Food and Drug Administration (FDA) Commissioner Marty Makary, according to sources familiar with discussions inside the White House. While officials say the decision is not yet finalized, multiple insiders claim Makary’s exit is increasingly likely as criticism surrounding his leadership continues to grow.
The reported move comes after mounting pressure from conservative media outlets, pharmaceutical industry stakeholders, anti-abortion groups, and supporters of Health and Human Services Secretary Robert F. Kennedy Jr. The Wall Street Journal recently published several editorials criticizing Makary’s management of the FDA, particularly over the agency’s rejection of Replimune’s melanoma treatment application. Makary defended the decision during a CNBC interview, stating that FDA scientists — not the commissioner — were responsible for the outcome.
News of Makary’s possible dismissal boosted investor confidence, with Replimune shares jumping sharply following the report. Analysts suggested that a leadership change at the FDA could improve stability and predictability for the biotech and pharmaceutical sectors.
Makary has also faced backlash over delayed action on a promised safety review of abortion pills. Anti-abortion organizations have intensified calls for his removal, arguing that the FDA has failed to address concerns important to conservative voters. In addition, Trump reportedly expressed frustration with Makary’s handling of flavored e-cigarette approvals, an issue tied to campaign promises made during the 2024 election.
The White House is reportedly considering FDA Deputy Commissioner Kyle Diamantas as interim commissioner. Former FDA Commissioner Stephen Hahn and former acting commissioner Brett Giroir are also being discussed as possible long-term replacements.
Makary’s potential departure adds to ongoing instability within federal health agencies, which have experienced significant staff losses, leadership turnover, and internal disputes in recent months. Experts warn that rebuilding the FDA’s leadership structure could become a major challenge for the next commissioner.
