FDA upheaval: Høeg named CDER chief as mRNA coalition warns of agency turmoil

Tracey Beth Høeg, a physician and epidemiologist with prior critiques of COVID‑19 vaccine policy, was appointed acting director of the FDA’s Center for Drug Evaluation and Research. The move marks the fifth leadership change at CDER in 2025 and comes amid broader agency turbulence. Separately, the industry’s mRNA coalition publicly warned that ongoing leadership instability at the FDA is undermining public trust and could jeopardize review timelines for advanced modalities. The developments have prompted analysts and industry groups to reassess regulatory risk for vaccine and biologics programs. Sources: FDA staffing notices and industry coalition statements.