FDA’s Acting Drug Center Director Tracy Beth Høeg Steps Down Amid Agency Turmoil

Dr. Tracy Beth Høeg is leaving her role as acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), the division responsible for regulating prescription and over-the-counter drugs, according to a senior FDA official and a Department of Health and Human Services (HHS) spokesperson. Høeg’s departure comes just days after former FDA Commissioner Dr. Marty Makary resigned amid internal agency conflicts.

Høeg, a sports medicine physician who served as acting CDER director for about five months, had been a close advisor to Makary and was previously his special assistant. Makary resigned following disputes over the FDA’s decision to approve flavored e-cigarettes, a move he reportedly opposed but was overruled on by other administration members. Michael Davis, the deputy center director at CDER, will assume the acting director role, while Kyle Diamantas, the FDA’s top food regulator, is temporarily filling Makary’s position.

HHS spokesperson Emily Hilliard stated that the administration is actively seeking strong candidates for leadership roles within HHS and the FDA, emphasizing the need for experienced individuals to strengthen agency operations and maintain public trust. She added, “In the meantime, the FDA and HHS continue to operate under solid leadership and respond aggressively to immediate public health situations.”

Høeg’s tenure at the FDA was marked by controversy. She had previously criticized COVID-19 vaccines for children and was involved in efforts to reduce the number of recommended childhood vaccines. In December, she co-wrote a scientific assessment supporting the Trump administration’s overhaul of the childhood vaccine schedule, which proposed reducing the number of vaccines from 18 to 11 diseases, aligning more closely with Denmark’s schedule. However, a federal judge temporarily blocked these changes in March.

At a vaccine advisory meeting in December, Høeg argued that fewer universal vaccines would reduce children’s exposure to aluminum, a vaccine ingredient that has been extensively studied and deemed safe. Despite this, anti-vaccine groups have falsely linked aluminum to autism. Høeg holds dual citizenship in the U.S. and Denmark.

Her appointment as CDER head had alarmed some senior FDA officials due to her vaccine skepticism. One agency source told CBS News in December, “Putting Tracy Beth in charge is like dropping an atom bomb.”

During her time at the FDA, Høeg challenged some agency decisions. In June of last year, she raised safety concerns about treatments for respiratory syncytial virus (RSV) in infants that had already been approved. More recently, she opposed the FDA’s fast-track review of teplizumab, a diabetes drug developed by Sanofi.

Høeg acknowledged the effectiveness of some vaccines, including the measles vaccine, and stated upon her confirmation that she was “committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently.”

Her departure follows the recent exit of Dr. Vinay Prasad, the former head of the FDA office responsible for vaccine approvals, who left the agency last month after briefly departing the previous summer.