Controversial Vaccine Skeptic Named Acting Head Of FDA Drug Office, Prompting Resignations And Alarm

Acting Director Appointment Stuns FDA Officials

The Trump administration's elevation of Dr. Tracy Beth Høeg to acting director of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) has prompted sharp alarm among senior agency officials, who told CBS News the move could damage the FDA's reputation as a reliable steward of the nation's drug supply.

Høeg was appointed on Wednesday to lead CDER, the FDA division responsible for evaluating new medicines, approving prescription and over‑the‑counter drugs, and ensuring adequate supplies of existing therapies. Her selection followed the abrupt resignation of Richard Pazdur, a longtime FDA scientist who had assumed the post only three weeks earlier.

"Putting Tracy Beth in charge is like dropping an atom bomb," one agency source said. "It's an extinction level event. Tracy Beth Høeg has never supervised a drug review, never has conducted a clinical trial. She doesn't understand laws and regulations."

A spokesperson for the Department of Health and Human Services did not respond to questions about Høeg's qualifications, and Høeg did not reply to requests for comment.

In a statement when she was appointed, Høeg said: "I am committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently."

Controversies and a Disputed Memo

Høeg has been a contentious figure in recent public‑health debates. This autumn she argued for stricter limits on COVID‑19 vaccination for young men because of concerns about a rare side effect, myocarditis, according to STAT News. Since joining the FDA in March, she has advised Commissioner Marty Makary on vaccine policy and helped draft a memo asserting that FDA leaders found at least 10 children had died "after and because of" receiving the COVID‑19 vaccine. The memo, obtained by CBS News, included no supporting data; HHS said it expects to release related data soon.

The same memo proposed changes in how the agency would handle COVID‑19 and certain other vaccines and suggested that staff who disagreed should resign. After the memo became public, a dozen former FDA leaders condemned the proposals in the New England Journal of Medicine, writing that they "undermine a regulatory model designed to ensure vaccine safety, effectiveness, and availability" and represent a major shift in the FDA's understanding of its role.

Concerns About Politicization And Industry Impact

One senior FDA official expressed broad concern that Høeg could politicize an office traditionally guided by science. The source warned that if regulatory decisions appear politicized, pharmaceutical companies may lose confidence in the FDA as a predictable partner and consider developing products overseas in jurisdictions they view as more stable.

Background And Recent Activities

Høeg is a sports medicine physician and epidemiologist. She served as the FDA's representative on a Centers for Disease Control and Prevention advisory panel that included appointees aligned with Health Secretary Robert F. Kennedy Jr.; that panel recently revised guidance on when children should receive their first dose of the hepatitis B vaccine.

At the advisory meeting, Høeg questioned aspects of the U.S. childhood immunization schedule, calling the country an "international outlier" and asking whether the scope of the U.S. schedule is scientifically justified. She also acknowledged vaccine benefits when discussing a recent measles surge, saying, "The increase is predominantly among the unvaccinated. ... The measles vaccine does prevent measles, and we are seeing cases among unvaccinated children."

Commissioner Marty Makary defended the appointment, calling Høeg "the right scientist to fully modernize" CDER and saying she has "advanced scientific rigor through her commitment to providing the public with the highest quality of evidence."

Leadership Turbulence At The Drug Office

Høeg is the fifth person this year to head CDER amid a turbulent period of sudden leadership changes. In November, George Tidmarsh resigned after federal officials opened a review into concerns about his conduct; he has denied wrongdoing. Pazdur, a 26‑year FDA veteran known for his work on cancer drug approvals, left after clashing with Makary. Sources said Pazdur accepted the role on the condition that Makary would not interfere with the office's work; when Makary began interviewing candidates for roles Pazdur oversaw, Pazdur demanded Makary's resignation and ultimately stepped down when that did not occur.

As the agency transitions, many FDA staff and external stakeholders will be watching closely to see whether science‑based review processes and regulatory standards remain intact.