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3mo ago

FDA Installs Tracy Beth Hoeg as Acting CDER Director as Pazdur Files Retirement

The acting appointment underscores internal rifts over rapid‑review plans that have unsettled stakeholders.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
Senior Advisor for Clinical Sciences at the FDA Tracy Beth Hoeg, MD, PhD, speaks at the meeting of the members of the Advisory Committee on Immunization Practices as the U.S. Centers for Disease Control and Prevention's (CDC) advisory panel for vaccines convenes, in Atlanta, Georgia, U.S. June 25, 2025.  REUTERS/Megan Varner
Richard Pazdur, director for the Office of Oncology Drug Products, Office of New Drugs at the Federal Food and Drug Administration (FDA), testifies during a Food and Drug Administration (FDA) hearing in Silver Spring, Maryland, U.S., on Tuesday, June 28, 2011. Breast-cancer patients and their families urged U.S. regulators to back down from a plan to withdraw approval for Roche Holding AG's Avastin, saying the treatment offered significant benefits for some women. Photographer: Joshua Roberts/Bloomberg via Getty Images
Richard Pazdur, FDA’s drug evaluation chief, to leave FDA just weeks into new role

Overview

  • The FDA confirmed Richard Pazdur submitted paperwork to retire at the end of December, only weeks after taking over the agency’s drug center.
  • Tracy Beth Hoeg was named acting director of CDER, with Commissioner Marty Makary calling her the right scientist to modernize the division.
  • Multiple reports tie Pazdur’s decision to clashes over the Commissioner’s National Priority Voucher rapid‑review program and concerns about political influence in regulatory decisions.
  • Reports indicate Pazdur could still rescind his retirement within a short window, leaving uncertainty over permanent leadership at CDER and the Oncology Center of Excellence he founded.
  • Industry leaders and former FDA commissioners warned that ongoing turnover is eroding predictability for drug reviews, and biotechnology shares fell after news of Pazdur’s planned exit.