FDA drug chief expected to leave amid health department shake-up

Tracey Beth Hoeg was expected to leave the Food and Drug Administration’s drug center just days after Marty Makary resigned, deepening concerns that the agency’s drug review apparatus is losing stability at a moment when patients, drug makers and regulators all need continuity.

The exit would hit the FDA’s Center for Drug Evaluation and Research, the agency’s largest center and the unit that regulates most prescription and over-the-counter medicines. Any further turnover there raises immediate questions about pending approvals, safety oversight and whether manufacturers can trust that review timelines and enforcement decisions will stay consistent.

Hoeg, an epidemiologist and sports physician with an M.D. and a Ph.D. in public health and epidemiology, was an unusual choice for such a central regulatory job. She had previously cast doubt on COVID vaccines during the pandemic, and at the FDA she helped lead the effort to overhaul the nation’s childhood immunization schedule. The changes, set in motion after President Donald Trump issued a December 5, 2025 memorandum directing HHS and the CDC to review peer countries’ vaccine schedules, were formally signed by acting CDC director Jim O’Neill on January 5, 2026.

That overhaul cut the number of diseases addressed in the childhood schedule from 18 to 11, dropping routine recommendations for hepatitis A, hepatitis B, RSV, dengue, meningitis, COVID-19 and influenza. The CDC said its review examined 20 peer, developed nations. But a federal judge in Massachusetts blocked the changes on March 16, and more than 200 medical groups said they would follow the American Academy of Pediatrics’ schedule instead of the federal version.

Makary’s resignation on Tuesday widened the sense of upheaval. He had clashed with lawmakers, major pharmaceutical companies and Trump, and Trump said Deputy Commissioner Kyle Diamanta would temporarily take over. White House-linked health officials have also been pushing to remove controversial appointees and bring in more traditional nominees for top posts, including CDC director and surgeon general, while several lower-level FDA officials are expected to leave as well.

The staffing churn carries consequences well beyond Washington. Hoeg’s appointment had already alarmed senior FDA officials in late 2025, when multiple top-level staff members were preparing resignations. Now, with the vaccine overhaul blocked in court and federal health policy in flux, the department faces pressure not only to defend its decisions but to prove it can still operate as a steady steward of the drug supply. HHS spokeswoman Emily Hilliard said, “HHS and FDA do not comment on personnel matters.”