Dr. Tracy Beth Høeg, acting head of the FDA’s Center for Drug Evaluation and Research, is leaving her post, underscoring fresh leadership churn at the agency only days after FDA Commissioner Dr. Marty Makary resigned amid internal clashes tied to approval of f
When Dr.. Marty Makary stepped down as FDA commissioner. the explanation coming from inside the agency was that it boiled down to a fight over flavored e-cigarettes.. Three days later. another top FDA leader responsible for reviewing prescription and over-the-counter drugs is exiting her role—signaling that the internal shake-up is not slowing down.
Dr. Tracy Beth Høeg, the acting director of the FDA’s Center for Drug Evaluation and Research (CDER) since December, is leaving her post, a senior FDA official confirmed to CBS News. CDER oversees the review of applications for new drugs.
Høeg’s departure lands on the heels of Makary’s resignation following what CBS News described as a flood of reports about internal tensions at the agency. including disagreements over a recent decision to approve flavored e-cigarettes.. A source familiar with the matter told CBS News that Makary left due to the e-cigarette dispute. saying the commissioner did not want to approve flavored products but was forced to do so by other members of the administration.. A Health and Human Services spokesperson did not immediately respond to a request for comment.
The leadership churn has also reached beyond the e-cigarette fight. The former head of the FDA office responsible for vaccine approvals, Dr. Vinay Prasad, also departed the agency last month. Prasad left briefly last summer, then was reinstated less than two weeks later.
Høeg’s role at CDER has been a flashpoint since her appointment drew controversy and alarm among senior FDA officials. with CBS News previously reporting concerns tied to her history of vaccine skepticism.. She helped write a memo last year linking several children’s deaths to the COVID-19 vaccine without providing data to back up the claim. and she was involved in a controversial effort to reduce the number of recommended childhood vaccines.
One agency source told CBS News in December that putting Høeg in charge was like “dropping an atom bomb.”
Still, Høeg has acknowledged the effectiveness of some vaccines, including the measles vaccine. When she was confirmed, she said she was “committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently.”
For now. the FDA is left to fill another critical leadership gap in a period when senior officials are already dealing with fallout from Makary’s resignation and the internal disagreements that have been tied to the agency’s handling of flavored e-cigarettes.. With Høeg’s exit coming so quickly. questions are likely to sharpen about who gets to set the tone for drug approvals—and how much influence top leadership is able to exert when policy decisions become contested inside the agency.
FDA Tracy Beth Høeg CDER drug approvals Marty Makary flavored e-cigarettes vaping vaccine skepticism Vinay Prasad leadership shake-up