The leadership shake-up at the U.S. Food and Drug Administration continued Friday as Dr. Tracy Beth Høeg stepped down from her role overseeing the agency’s drug regulation division, just days after FDA Commissioner Marty Makary resigned.
A Department of Health and Human Services official confirmed that Høeg is leaving her position as acting director of the FDA’s Center for Drug Evaluation and Research (CDER), the division responsible for regulating prescription and over-the-counter medications in the United States.
Høeg, a sports medicine physician known for criticizing Covid-19 vaccine recommendations for children during the pandemic, had led the division for approximately five months under the Trump administration.
Her departure marks the latest major change within the FDA leadership team amid ongoing policy disputes and controversy surrounding public health decisions.
Høeg previously served as a special assistant to Makary, who resigned earlier this week following reported disagreements with the Trump administration over efforts to expand access to flavored e-cigarettes.
Michael Davis, CDER’s deputy center director, will now serve as acting director of the division, while FDA food regulator Kyle Diamantas temporarily assumes leadership responsibilities previously held by Makary.
The Department of Health and Human Services said the administration is actively searching for permanent leaders for several key positions across the agency.
“FDA and HHS continue to operate under solid leadership and respond aggressively to immediate public health situations,” HHS spokesperson Emily Hilliard said in a statement.
Høeg’s tenure at the FDA was marked by several controversial disagreements involving agency decisions and pharmaceutical policy.
Reports indicated she raised safety concerns about already-approved respiratory syncytial virus (RSV) treatments for infants and recently opposed the fast-tracking of teplizumab, a diabetes drug developed by pharmaceutical company Sanofi.
She also played a role in the Trump administration’s effort to overhaul the U.S. childhood vaccination schedule.
Høeg co-authored a scientific assessment used to support changes announced earlier this year that reduced the number of universally recommended childhood vaccines from 18 diseases to 11, aligning the schedule more closely with Denmark’s vaccination model.
However, a federal judge temporarily blocked the revised vaccine schedule in March following legal challenges.
At a vaccine advisory meeting last year, Høeg argued that reducing the number of routine childhood vaccines could lower aluminum exposure in children. Medical experts have long maintained that aluminum salts used in vaccines are safe and not linked to autism, despite ongoing claims promoted by anti-vaccine groups.
The latest departures add to growing uncertainty within the FDA as the agency faces mounting scrutiny over vaccine policy, tobacco regulations and broader public health leadership under the Trump administration.