The FDA Put a Vaccine Skeptic in Charge of Drug Regulation. Now She Is Out.
The FDA Put a Vaccine Skeptic in Charge of Drug Regulation. Now She Is Out.
Tracy Beth Høeg arrived at the FDA with a history of questioning the very products she would be asked to evaluate. By the time she left, she had become the fifth person to lead the agency's drug review center in roughly sixteen months — and her brief tenure had produced a concrete example of exactly what her former boss said should never happen.
Høeg, an epidemiologist and sports medicine physician, is expected to depart the FDA immediately, just days after Commissioner Marty Makary resigned, according to three people familiar with internal planning at the agency (Reuters). Her exit marks the end of a five-month stint that began December 3rd, 2025, when she took over from Richard Pazdur, a veteran oncologist who himself lasted only weeks in the role (Wikipedia).
The churn at the Center for Drug Evaluation and Research is without recent precedent. Five directors in sixteen months of Trump's second term, after years in which the position typically turned over once or twice per administration (BioSpace). Thousands of experienced career reviewers left the agency last year as part of Elon Musk's Department of Government Efficiency cuts, hollowing out the scientific staff that typically buffers political leadership from day-to-day regulatory decisions (Reuters).
Høeg's tenure was defined by the same tensions that surrounded Makary's commissionership: a deep skepticism toward mainstream medical consensus, elevated to the point of operational consequence. She helped lead the effort to cut the recommended childhood vaccination schedule from seventeen shots to eleven, a change that was almost immediately frozen by litigation. She considered relabeling Covid-19 vaccines to say the risks outweighed the benefits for males aged twelve to twenty-four, a plan that drew fierce objection from cardiologists and public health experts. She raised safety questions about RSV vaccines for infants made by Merck, Sanofi, and AstraZeneca (Reuters).
The clearest illustration of how those views shaped actual decisions came in the Sanofi dispute. Høeg overrode a staff recommendation to approve an expanded label for teplizumab, Sanofi's Type 1 diabetes drug, prompting the company to ask the FDA to remove the drug from Makary's flagship Commissioner National Priority Review program. The agency missed its April 21st decision deadline. Sanofi pulled the drug from the program (STAT News). Makary, in a CNBC interview recorded before the dispute became public, had said: "Disaster occurs whenever political leaders overrule scientific staff."
That Høeg did exactly what Makary described as catastrophic is not a contradiction the FDA has acknowledged publicly. Her departure, like his, was described by HHS as a personnel matter on which the department would not comment.
Chris Klomp, installed as Health Secretary Robert F. Kennedy Jr.'s deputy, is now pushing to replace the remaining Makary loyalists with more conventional nominees, according to two people familiar with the effort (Reuters). Lower-level officials expected to leave include chief of staff Jim Traficant, deputy chief of staff Samuel Doran, and associate director of policy and research strategy Sanjula Jain-Nagpal.
The drugs caught in the churn face an uncertain path. Teplizumab, now outside the priority review program, returns to ordinary review queues with no timeline for resolution. The RSV vaccines Høeg flagged remain on the market but under an informal cloud. And the children's vaccine schedule, reduced on paper to eleven shots, is in litigation that shows no signs of imminent resolution.
What comes next is a CDER director who, unlike Høeg, will not have built a public reputation as a skeptic of the products under review. Whether that represents a return to normalcy or simply a different form of dysfunction remains to be seen. Five directors in sixteen months does not leave much room for normal.