Tracy Beth Høeg named acting FDA CDER chief
The FDA appointed Dr. Tracy Beth Høeg acting director of its Center for Drug Evaluation and Research on Wednesday after Richard Pazdur resigned three weeks into the post. Multiple senior FDA officials told CBS News the move could politicize a science-focused office that oversees U.S. drug approvals and supply, noting Høeg has advised vaccine policy and helped draft a recent internal memo alleging pediatric COVID‑vaccine deaths that drew rebukes from former FDA leaders in the New England Journal of Medicine.
📌 Key Facts
- Appointment: Høeg tapped as acting CDER director on Dec. 3, 2025 after Pazdur’s abrupt resignation
- Internal reaction: multiple senior FDA officials fear politicization and say some are preparing to resign
- Policy backdrop: Høeg advised Commissioner Marty Makary on vaccines and helped write a memo asserting at least 10 pediatric COVID‑vaccine deaths; HHS says data will be released soon and ex‑FDA leaders criticized proposed changes in NEJM
📊 Relevant Data
The risk of myocarditis following mRNA COVID-19 vaccination is highest in adolescent and young adult males, with rates up to 17 per million doses for Pfizer-BioNTech in certain age groups.
Updated COVID-19 vaccine (2024-2025 Formulation) | ACIP — CDC
As of June 2025, CDC reports documented deaths from myocarditis and pericarditis following COVID-19 vaccination, including cases in children, but does not specify an exact number of pediatric deaths directly caused by the vaccine.
The US childhood immunization schedule requires 26 vaccine doses for infants under 1 year, which is more than in many other developed countries.
ACIP is comparing the US childhood vaccine schedule with those of other countries — Infectious Diseases Society of America (Facebook)
The US recommends hepatitis B vaccination at birth due to differences in disease epidemiology, including higher chronic hepatitis B prevalence in certain populations compared to other countries where vaccination is delayed.
Global Vaccination Schedules — Vaccine Knowledge Project (Oxford)
In the US, Asian Americans have the highest incidence and mortality rates of hepatocellular carcinoma, often linked to chronic hepatitis B, with rates significantly higher than other racial/ethnic groups; for context, Asian Americans comprise about 7% of the US population.
Previous FDA CDER directors, such as Richard Pazdur, have had over 26 years of experience at the FDA, including expertise in oncology and drug evaluation.
FDA announces agency veteran will become top drug regulator after controversy — The Hill