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10h ago

FDA Names Mike Davis Acting Drug Chief as Tracy Beth Høeg Exits

The swift reshuffle signals unsettled control of the FDA’s drug and vaccine reviews during the search for permanent leaders.

FILE - Dr. Tracy Beth Hoeg, with the FDA, listens during a meeting of the Advisory Committee in Immunization Practices at the CDC, June 25, 2025, in Atlanta. (AP Photo/Mike Stewart, File)
Dr. Marty Makary, commissioner of the Food and Drug Administration, center, speaks while National Institutes of Health Director Dr. Jay Bhattacharya, left, and Health and Human Services Secretary Robert F. Kennedy Jr., right, listen in the Oval Office of the White House, Saturday, April 18, 2026, in Washington. (AP Photo/Julia Demaree Nikhinson)
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Overview

  • The FDA said Friday that acting drug center chief Tracy Beth Høeg is out, with deputy Mike Davis now serving as acting director.
  • An internal email to staff Friday named Karim Mikhail acting head of the vaccines and biologics center, replacing Katherine Szarama.
  • Høeg said she was fired and refused to sign a resignation letter, describing a choice presented by agency officials to resign or be terminated.
  • The departures follow Tuesday’s resignation of Commissioner Marty Makary after disputes over the decision to allow flavored e‑cigarettes.
  • Davis becomes the fifth leader of the drug center since last January, and HHS says it is seeking permanent nominees, raising concerns that frequent turnover could slow drug and vaccine reviews that CDER and CBER oversee.