FDA turmoil deepens as drug center chief Tracy Hoeg is fired

The Food and Drug Administration’s drug-safety machinery lost another senior figure as Tracy Beth Hoeg said she did not know who fired her or why, deepening a leadership vacuum at an agency already running on temporary managers. Hoeg had been acting director of the Center for Drug Evaluation and Research, the FDA division that regulates prescription and over-the-counter drugs, putting her at the center of decisions that shape whether medicines reach patients and how closely they are watched afterward.

Her dismissal came days after Commissioner Marty Makary resigned, a blow that adds to a broader scramble across the agency. Temporary leaders are now filling top roles at the FDA, including commissioner, the food chief and the head of the biologics center, which oversees vaccines and gene therapies. The roles of surgeon general and director of the Centers for Disease Control and Prevention are also unfilled, leaving federal public-health oversight split between acting officials and open chairs at a moment when confidence in the system is already under strain.

Hoeg’s departure carries added political weight because she helped lead the effort to overhaul the federal childhood vaccination schedule. In January, the recommended number of shots was cut from 17 to 11, and Hoeg co-wrote the scientific assessment used to justify that change. The move has been folded into the broader controversy surrounding vaccine policy under Health Secretary Robert F. Kennedy Jr., sharpening concerns that science, rather than politics, may no longer be the sole driver of federal health decisions.

The instability matters well beyond internal personnel drama. CDER is one of the FDA’s most powerful centers, with direct responsibility for the approval and safety of drugs used by millions of Americans. When its acting director is suddenly out and the agency’s top leadership is in flux, routine review work, enforcement priorities and safety judgments can all slow down, shift course or become vulnerable to political pressure. Hoeg’s exit, paired with the vacancies above her, makes the question facing the FDA not just who is in charge, but whether the agency can still project the independence that drug approval and oversight demand.