The acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), Dr. Tracy Beth Høeg, is leaving her post, a senior FDA official confirmed to CBS News. CDER oversees the review and approval of prescription and over-the-counter drugs, making Høeg’s departure a notable change within the agency’s leadership.
Høeg had served as acting director since December and previously advised former FDA Commissioner Dr. Marty Makary. Her tenure attracted controversy due to her history of vaccine skepticism, including involvement in a 2025 memo that linked several children’s deaths to COVID-19 vaccines without supporting data. She also participated in efforts aimed at reducing recommended childhood vaccinations. Some senior FDA officials expressed alarm when she was appointed, warning of potential disruption within the agency.
Dr. Høeg has stated her commitment to transparency, honesty, and science-based decision-making, acknowledging the effectiveness of vaccines such as the measles vaccine. Her departure follows that of Dr. Vinay Prasad, former head of the FDA office responsible for vaccine approvals, who left the agency last month after briefly departing the previous summer.
The announcement comes shortly after Dr. Makary resigned as FDA commissioner amid reports of internal conflicts, particularly over the agency’s decision to approve flavored e-cigarettes. According to a source familiar with the situation, Makary opposed approving flavored e-cigarettes but was pressured by other administration members to authorize them, leading to his resignation.
A spokesperson for the Department of Health and Human Services did not immediately respond to requests for comment regarding Høeg’s departure.
Why it matters
Leadership changes at the FDA’s drug review center come at a critical time when the agency faces public scrutiny over regulatory decisions and internal disagreements. The resignations highlight ongoing tensions within the FDA concerning drug approvals, vaccine policy, and e-cigarette regulations, which have significant implications for public health and trust in the agency.
Background
The FDA’s Center for Drug Evaluation and Research plays a central role in assessing the safety and efficacy of new medications. Changes at its helm can affect the timing and standards of drug approvals. In the past year, the agency has experienced several high-profile departures, reflecting broader challenges as it balances scientific assessment, public health priorities, and political pressures.
Sources
This article is based on reporting and publicly available information from the following source:
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