Top FDA drug regulator fired amid agency leadership shake-up

The firing of Tracy Beth Hoeg deepened the FDA’s leadership void at the very moment its drug center is weighing decisions on antidepressants, pediatric RSV drugs and COVID-19 vaccines. Hoeg, who led the Center for Drug Evaluation and Research in an acting role, said on social media that she had been “fired” and did not know who had removed her or why.

The move shifts day-to-day control of the FDA’s drug program to Dr. Mike Davis, previously the deputy director. That matters well beyond one personnel change: CDER is the agency unit charged with ensuring that safe, effective and high-quality drugs are available to the public, and its leaders typically come from the agency’s career scientific ranks after decades of experience. Hoeg did not. She arrived at the FDA in March 2025 with no prior government or management background, after first drawing attention during the pandemic as a critic of masking, school closures and vaccine mandates.

During her brief tenure, Hoeg oversaw internal scrutiny of injectable RSV drugs for children, antidepressants and COVID-19 vaccinations. An internal FDA memo discussed last November described an “initial analysis” that linked COVID-19 shots to 10 reported deaths in children, though the underlying evidence was not publicly released. The scrutiny put her at the center of some of the agency’s most sensitive questions about benefit, risk and public confidence in vaccines and other widely used treatments.

Her removal also comes as the FDA itself is changing shape from the top down. Marty Makary resigned as FDA commissioner on May 12, 2026, and Kyle Diamantas became acting commissioner. Earlier in May, Vinay Prasad departed as head of the FDA’s Center for Biologics Evaluation and Research. The changes come amid broader vacancies across the Department of Health and Human Services, including no Senate-confirmed surgeon general and an acting head at the Centers for Disease Control and Prevention.

Public health experts have warned that the churn is unusual and could weaken the government’s ability to respond to outbreaks and other crises. One former CDC official described the turmoil as “a sign that something is not right in this department.” With multiple posts now held by acting officials, the FDA faces a thinner bench to steer pending drug and biologics decisions, and a harder task in convincing doctors, patients and researchers that its judgments are stable, scientific and insulated from political pressure.