The Food and Drug Administration is facing an acute personnel crisis that has left the agency operationally fragile heading into 2026. STAT reports that the FDA has cycled through five leaders of its drug center since January, seen waves of departures and resignations, and is wrestling with internal feuds that have prompted HHS and White House officials to weigh curbing Commissioner Marty Makary’s remit. Those changes coincide with concerns about politicization and low morale inside the regulator, sources told STAT and Politico. The churn matters to biotech firms and trial sponsors because unstable leadership can slow review timelines, reshape enforcement priorities, and complicate regulatory strategy for new drugs and biologics. Industry stakeholders should expect heightened uncertainty around regulatory guidance and personnel-driven delays in the near term.
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