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2w ago

FDA Drug Chief Richard Pazdur Files to Retire Weeks After Taking CDER Helm

The filing follows clashes over a proposed rapid‑review voucher program, reflecting concern about political involvement in drug decisions.

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 Pazdur submitted retirement paperwork effective at the end of December, less than a month after his Nov. 11 appointment to lead CDER.
  • His exit would leave vacancies at both the Center for Drug Evaluation and Research and the Oncology Center of Excellence, which he founded in 2017.
  • Reports attribute his decision to disputes with Commissioner Marty Makary and senior officials over the National Priority Voucher rapid‑review plan and perceived political interference in reviews.
  • Several outlets report he could rescind the filing within a procedural window, though the agency has publicly acknowledged receiving his retirement paperwork.
  • The news intensified concern over leadership churn at the FDA and weighed on biotech shares, with analysts warning of greater uncertainty for drug review timelines and policy direction.