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FDA Leadership Shaken: New Acting CDER Director Appointed as OTC Chief Reassigned Amid Vaccine Policy Debate

The FDA has appointed Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research amid a year of rapid leadership turnover. Høeg, who previously worked at CBER, has advocated reexamining aspects of vaccine guidance and childhood immunization scheduling. Theresa Michele, who led over-the-counter drug regulation for a decade, is being reassigned to a medical devices leadership role. A bipartisan group of former FDA commissioners warned that recent policy shifts and personnel moves raise concerns about transparency and the agency’s direction.

01:51 PM, 12/04/2025Health

The U.S. Food and Drug Administration has moved quickly to reshuffle senior leadership at its drug-review center while facing growing scrutiny over proposed changes to vaccine policy. Tracy Beth Høeg has been named acting director of the FDA’s Center for Drug Evaluation and Research (CDER), following multiple leadership changes at the center this year.

Appointment and background
Commissioner Marty Makary praised Høeg as a scientist who can help modernize CDER and strengthen cross-center coordination. Høeg previously worked at the Center for Biologics Evaluation and Research (CBER) and has been involved in initiatives to advance scientific rigor and develop alternatives to animal testing.

Policy views and controversy
Høeg has aligned with Commissioner Makary on several vaccine-related positions. She has publicly advocated for revisiting aspects of COVID-19 vaccine guidance, urged changes to vaccine labeling for certain age and sex groups, and supported reevaluating parts of the childhood immunization schedule. Those stances have prompted debate among public-health experts and former agency leaders about the implications for public trust and vaccine policy.

Rapid turnover at CDER
Høeg succeeds Richard Pazdur, a long-time FDA official who retired after a brief tenure as CDER director. His departure follows a string of leadership changes at the center earlier this year, which also included George Tidmarsh and acting director Jacqueline Corrigan-Curay. The rapid turnover has intensified attention on how staffing changes may affect the agency’s regulatory continuity.

Reassignment of OTC drugs chief
Theresa Michele, who led the FDA’s Office of Nonprescription Drugs for a decade, is being reassigned to a leadership role within the agency’s medical devices center. According to an internal announcement she shared with staff, the personnel move takes effect Thursday. Agency leadership has indicated the OTC office will place greater emphasis on affordability going forward.

Reaction from former agency leaders
A bipartisan group of a dozen former FDA commissioners issued a pointed warning that recent proposed directives on vaccine policy represent more than minor adjustments. They argued such changes could signal a major shift in the agency’s role and criticized a perceived lack of transparency in the decision-making process. Other former officials and observers have expressed concern that rapid personnel shifts and evolving policy directions could undermine public confidence in the FDA’s scientific and regulatory judgments.

What to watch next
Observers will be watching how the new CDER leadership balances scientific review, public-health priorities and stakeholder concerns. The administration of vaccine guidance, the pace of over-the-counter drug approvals, and the agency’s approach to transparency are likely to remain focal points for Congress, public-health groups, and industry stakeholders in the months ahead.

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FDA Leadership Shaken: New Acting CDER Director Appointed as OTC Chief Reassigned Amid Vaccine Policy Debate - CRBC News