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FDA Names Tracy Beth Høeg Acting CDER Director as OTC Drugs Chief Is Reassigned

The shuffle follows Richard Pazdur’s rapid exit, extending a year of churn at the drug regulator.

Overview

  • Høeg, a physician–epidemiologist and senior adviser to Commissioner Marty Makary, was appointed acting head of the Center for Drug Evaluation and Research effective Dec. 3.
  • She becomes the fifth person to lead CDER in 2025 after Richard Pazdur accepted the post in November and filed to retire weeks later.
  • Theresa Michele, who had led the Office of Nonprescription Drugs since 2015, was removed from that role and moved to a leadership position in the FDA’s medical devices center.
  • An HHS official said the over‑the‑counter drugs office is being refocused on affordability, and Michele’s portfolio had included reviews of common consumer medicines such as pain relievers and flu treatments.
  • Becker’s reported that Karen Murry, MD, was named to lead the over‑the‑counter drugs office as analysts warn the leadership turnover is adding uncertainty for the biotech sector.