FDA shakeup continues with departure of top drug regulator, just days after agency chief resigns

Dr. Tracy Beth Høeg is leaving her role as head of the FDA division that regulates over-the-counter and prescription drugs, according to a Department of Health and Human Services official.

Høeg, a sports medicine doctor who criticized Covid shots for children during the pandemic, served as acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research for about five months.

She was the fifth person to hold the post under the second Trump administration and the right hand to former FDA Commissioner Marty Makary, who resigned Tuesday after opposing the Trump administration’s moves to expand access to flavored e-cigarettes. Høeg was previously a special assistant to Makary.

Michael Davis, the deputy center director at CDER, will take over as acting director. Makary’s role is temporarily being occupied by Kyle Diamantas, the FDA’s top food regulator.

HHS did not immediately respond to a request for comment.

Emily Hilliard, an HHS spokesperson, said in a statement earlier Friday that the administration is “actively searching for strong candidates for key leadership positions across HHS, including the FDA, with a focus on experienced individuals who can strengthen agency operations, continue to advance significant reforms, and maintain public trust.”

“In the meantime, the FDA and HHS continue to operate under solid leadership and respond aggressively to immediate public health situations,” Hilliard said.

Dr. Tracy Beth Høeg in Atlanta in 2025.Megan Varner / Bloomberg via Getty Images file

Høeg drew controversy during her brief tenure at the FDA for challenging the agency’s own decisions.

As early as June of last year, Reuters reported, Høeg brought up safety questions about treatments for respiratory syncytial virus (RSV) in infants that had already been FDA-approved.

And just before her departure, she pushed back on an FDA decision to fast-track the review of teplizumab, a diabetes drug from pharmaceutical giant Sanofi, STAT News reported, citing sources familiar with the dispute.

Høeg also co-wrote the scientific assessment that the Trump administration used to justify its overhaul of the childhood vaccine schedule. In January, the administration altered the schedule to more closely resemble Denmark’s, recommending all children get vaccines for 11 diseases, compared with the 18 previously on the schedule. However, a federal judge temporarily blocked the changes in March.

At a vaccine advisory meeting in December, Høeg — who holds dual citizenship in the U.S. and Denmark — argued that giving fewer universal vaccines to children would reduce aluminum exposure. Nearly a century of evidence has demonstrated that the aluminum salts in vaccines, which aren’t the same as aluminum found in the environment, are safe. Nevertheless, anti-vaccine groups have targeted the ingredient, claiming falsely that it is linked to autism.