The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research (CDER), continuing the rapid rise of a physician who rose to prominence during the pandemic.
Høeg joined the FDA as special assistant to the commissioner in March, according to her LinkedIn. The appointment cemented ties between Hoeg and FDA Commissioner Marty Makary, M.D., with whom she co-authored a paper on the risks of COVID-19 vaccine boosters for young adults in 2022. Høeg became senior advisor for clinical sciences in the FDA’s Office of the Commissioner and biologics center in May.
Vinay Prasad, M.D., another co-author of the paper who is now at the FDA, recently shed light on how Høeg has spent her time at the agency. Prasad, who heads the FDA’s Center for Biologics Evaluation and Research, said Høeg has investigated reports of children dying after receiving COVID-19 vaccines.
“By late summer, she had concluded that there were in fact deaths—a fact this agency had never publicly admitted,” Prasad said in an internal email. While several experts said the claims require more scrutiny, Prasad used Høeg’s findings to make the case for tighter regulations of vaccines.
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Høeg, who specialized in sports medicine before gaining a reputation for challenging COVID-19 policies, will now take the lead at CDER on an acting basis. Makary said in a statement that Høeg is “the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there.”
The CDER director role became available after another period of whiplash changes at the FDA. George Tidmarsh, M.D., Ph.D., resigned from the position in early November amid an internal investigation into alleged misuse of his regulatory authority to act on a personal vendetta. Richard Pazdur, M.D., filled the vacancy on Nov. 11 but then swiftly signaled his intent to retire less than one month later.
Høeg’s appointment means Makary is now flanked by two people who followed him to the agency. All of the leaders criticized the FDA before joining the agency, with Høeg setting out the perceived failings of the regulator in a 2023 blog post titled “FDA’s shortcomings: A list.”
With Prasad’s center handling vaccines, Høeg lacks oversight of the products that dominated her critique of the FDA. Focused on vaccines, Høeg’s blog post covered postmarketing surveillance, staff moving between the FDA and industry, approvals that “are based on trials that are too small,” the “very slow process of removing drugs from the market,” transparency and direct-to-consumer advertising.
