New CDER Director Pazdur Files Retirement Papers
In an unexpected move, recently appointed CDER director Richard Pazdur has filed paperwork to retire by the end of the month, according to multiple reports citing people familiar with the matter. While the retirement paperwork has been filed, insiders indicate Pazdur could still change his mind and retract the resignation. Pazdur’s planned exit could cause a significant setback for FDA during a period of extraordinary turnover and institutional upheaval.
Pazdur was appointed last month to lead the drug center, replacing George Tidmarsh after he stepped down amid an internal ethics investigation and a defamation lawsuit tied to a public post criticizing a company’s drug (see story). Almost immediately, rumors began to swirl that Pazdur had questions about several new initiatives, including the new Commissioner’s National Priority Voucher (CNPV) pilot program because it may be unlawful and could jeopardize patient safety, according to the Washington Post. Internally, Pazdur has warned that the program’s framework may conflict with long-standing statutory requirements governing drug approvals. Tidmarsh had similarly warned that the initiative could upend decades of regulatory precedent.
Pazdur reportedly also raised concerns about commissioner Marty Makary’s efforts to sharply reduce evidence requirements for certain decisions — including label changes — from multiple studies to a single study. Makary has argued that lowering evidentiary burdens will help the agency act faster when new data emerge. Pazdur has countered that multiple studies are often necessary to ensure robust conclusions and protect public health, according to the Post.
These tensions come at a moment of turbulence for FDA, which has faced a wave of departures this year, including senior scientific staff. Makary has recently pushed for rapid changes to policies surrounding antidepressants, puberty blockers, psychedelics, and other politically sensitive areas. According to people familiar with the matter, Pazdur has urged that career scientists be central to these decisions, pushing back against efforts to exclude them from politically high-profile topics. Meanwhile, several industry groups sent letters to Makary and HHS Secretary Robert F. Kennedy Jr., complaining that the agency’s regulatory decisions have become erratic and less predictable, complicating drug-development planning.
Over two decades, Pazdur has become known for building integrated, cross-center review models and for advancing policies that sped the development and approval of novel cancer therapies. Among his signature efforts are Project Orbis, which enables coordinated review of oncology drugs among international regulators; Project Facilitate, a program to help clinicians secure expanded access to investigational cancer treatments; and Project Renewal, an initiative to update outdated labeling for older oncology drugs.
Before joining the agency, Pazdur was a professor of medicine at The University of Texas M.D. Anderson Cancer Center. He earned his medical degree from Loyola University Chicago’s Stritch School of Medicine and completed training at Rush-Presbyterian St. Luke’s Medical Center and the University of Chicago. He has authored more than 800 scientific publications and two oncology textbooks.
Pazdur’s planned exit could cause a significant setback for FDA during a period of extraordinary turnover and institutional upheaval. His departure further erodes managerial experience at a time when the agency is already under pressure to adapt its regulatory processes.