FDA Leadership Turmoil Continues as Vaccine Skeptic Named Acting CDER Director
The U.S. Food and Drug Administration (FDA) has appointed Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research (CDER), marking the latest shake-up in agency leadership amid ongoing controversy over vaccine policies.
Høeg's Rapid Rise Amid FDA Turnover
Høeg, who joined the FDA earlier this year as a special assistant to Commissioner Marty Makary, will become the fifth person to lead CDER in 2025 alone. Her appointment follows the abrupt retirement of Richard Pazdur, M.D., who stepped down just weeks after taking the role.
Prior to joining the FDA, Høeg specialized in sports medicine and gained prominence for challenging COVID-19 policies. She co-authored a 2022 paper with Makary on the risks of COVID-19 vaccine boosters in young adults.
Vaccine Safety Investigations and Policy Shifts
Høeg's appointment comes as the FDA faces increasing scrutiny over its handling of COVID-19 vaccine safety data. According to Vinay Prasad, M.D., director of the FDA's Center for Biologics Evaluation and Research, Høeg recently led an investigation into reports of children dying after receiving COVID-19 vaccines.
In an internal memo, Prasad stated that Høeg "concluded that there were in fact deaths—a fact this agency had never publicly admitted." While experts have called for further scrutiny of these claims, Prasad cited Høeg's findings to advocate for stricter vaccine regulations.
Industry Concerns Over FDA Stability
The frequent leadership changes at CDER have left the pharmaceutical industry reeling. John Crowley, head of the Biotechnology Innovation Organization, emphasized the need for "organizational strength and stability" at the agency following Pazdur's retirement announcement.
CDER oversees most new drug applications and regulates products ranging from over-the-counter medications to sunscreens. The division's instability comes amid broader turmoil at the FDA, including mass layoffs and resignations of key officials under Health and Human Services Secretary Robert F. Kennedy Jr.'s administration.
As Høeg takes the helm at CDER, questions remain about the future direction of drug regulation and vaccine policy at the FDA. Industry observers will be closely watching for any shifts in the agency's approach to drug approvals and safety monitoring under its new leadership.
References
- COVID Contrarian Tracy Beth Høeg Named as FDA’s Acting CDER Chief
Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.
- Tracey Beth Høeg, top Makary deputy, named head of FDA drug office
Høeg, a COVID-19 vaccine critic who’s been serving as a special assistant to the commissioner, will be the fifth person this year to run CDER amid heightening scrutiny of the agency.
- FDA names Tracy Beth Høeg, fresh from vaccine safety probe, as acting head of drug center
The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research, continuing the rapid ascent of a physician who rose to prominence during the pandemic.
- FDA names Tracy Beth Høeg, fresh from vaccine safety probe, as acting head of drug center
The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research, continuing the rapid ascent of a physician who rose to prominence during the pandemic.
Explore Further
What are Tracy Beth Høeg's qualifications and professional experience that make her a suitable choice for the acting director position at CDER?
What potential impact could the frequent leadership changes at CDER have on the pharmaceutical industry's drug development and approval processes?
How has the FDA been addressing the concerns raised by experts and industry leaders regarding organizational stability under its current administration?
What specific steps is Tracy Beth Høeg expected to take regarding the investigation into COVID-19 vaccine safety and related policy reforms?
How do the mass layoffs and resignations at the FDA align with broader trends in healthcare regulatory agencies, and how could this affect public trust?