Tracy Beth Høeg Named Acting Director of FDA's CDER Amid Vaccine Regulation Concerns
Tracy Beth Høeg was appointed acting director of the FDA's Center for Drug Evaluation and Research (CDER), becoming the fifth leader to head the center this year. With a background in sports medicine and epidemiology and a particular focus on vaccines, her appointment could indicate a closer partnership between CDER and the FDA's vaccine center (CBER). It also suggests a possible shift toward revising or dismantling already-approved vaccines as Høeg and Vinay Prasad consolidate influence.
The US government planned to radically change the childhood vaccine schedule to align with Denmark’s approach. However, this announcement was postponed to the new year. Such a move would position the US out of step with much of the world without clear evidence of benefit.
Critics highlight that Høeg appears to lack experience in drug development, regulation, or management, unlike previous center heads who had regulatory and drug-development expertise. Janet Woodcock and other former FDA leaders have voiced caution about the extent of CDER's responsibilities, emphasizing that the center's portfolio extends beyond vaccines and that leadership requires substantial management skill.
In contrast, Emily Hilliard of the Department of Health and Human Services defended Høeg's appointment, noting her background aligns with the role and pointing to her prior advisory work on drug safety, regulatory science, and vaccine surveillance.
Concerns have been raised about a trend toward laxer drug regulations, particularly regarding vaccines, which remain a focal point of scrutiny. There are worries about the lack of transparency around the priority voucher program, which accelerates drug approvals.
Høeg is known for a vaccine-contrarian track record, including research on myocarditis after Covid vaccination, advising Florida surgeon general Ladapo, questioning the use of aluminum adjuvants, and raising concerns about concurrent vaccine dosing. The FDA is currently investigating safety concerns related to the RSV vaccine.
This appointment comes amid broader concern within the medical community. In December, 12 former FDA commissioners, including Woodcock, signed a letter published in the New England Journal of Medicine warning about a lack of transparency in vaccine regulation changes.
