FDA Turmoil Deepens After Veteran Cancer Regulator Richard Pazdur Announces Retirement

FDA Faces Leadership Turmoil After Pazdur Departure

The Food and Drug Administration is contending with renewed scrutiny and internal upheaval after Dr. Richard Pazdur, a long-serving cancer researcher and influential architect of the agency’s oncology review process, announced his retirement. The move comes only weeks after Pazdur accepted leadership of the FDA’s largest division, which oversees prescription drugs, over‑the‑counter medicines and many pharmacy staples.

Sources familiar with internal discussions say Pazdur’s decision followed repeated clashes with Commissioner Marty Makary over personnel changes and the direction of drug-review policies. Pazdur reportedly objected to efforts to replace career drug regulators with hand‑picked political appointees and expressed concern that a push to accelerate review timelines could jeopardize long‑standing safety standards.

High-Level Meetings and Fallout

Health and Human Services Secretary Robert F. Kennedy Jr. met with Pazdur for about an hour as the agency sought to manage the fallout. An HHS spokesperson said Kennedy thanked Pazdur for his service. The retirement has raised alarms across the administration and the pharmaceutical industry about potential disruptions to the FDA’s science-driven review process and public confidence in the agency.

White House and HHS spokespeople publicly affirmed their support for Commissioner Makary. "The White House maintains complete confidence in Marty Makary and the entire team at HHS and FDA," White House spokesman Kush Desai said, praising the agency’s recent announcements.

Context: A Year of High-Profile Exits

Pazdur’s exit is the latest in a string of high-profile departures this year. In March, vaccine chief Peter Marks left amid public disputes with HHS leadership. Vinay Prasad briefly departed and later returned after a summer controversy; George Tidmarsh, a senior drug regulator, resigned amid unrelated allegations. Those departures, and occasional abrupt policy shifts, have contributed to perceptions of instability at the agency.

Internal tensions have sometimes centered on differences over process and independence. Sources say Pazdur initially declined the drug director role after Tidmarsh’s departure but accepted following a personal appeal from Commissioner Makary. He insisted on running the division free from political interference but reportedly grew frustrated by perceived attempts to overhaul review practices.

Policy Implications and Industry Concerns

Industry leaders and some administration officials worry that repeated leadership changes and proposals to speed reviews could erode trust in the FDA’s decisions. A recent memo proposing new vaccine-approval requirements, circulated by Vinay Prasad, alarmed some officials by suggesting the agency might re-evaluate already approved vaccines — a shift that raised questions about precedent and communication.

At a public meeting this week to discuss newborn hepatitis B vaccination recommendations, remarks by some advisers underscored the unusual timing of policy debates amid the leadership churn. The Advisory Committee on Immunization Practices later voted to recommend abandoning universal newborn hepatitis B vaccination — a decision observers linked to broader policy re-evaluations occurring while leadership is in flux.

Personnel Episodes and Internal Friction

Other personnel episodes have added to tensions. A close adviser to Makary, Sanjula Jain‑Nagpal, reportedly represented herself to stakeholders as the commissioner’s deputy chief of staff before the White House confirmed any promotion; officials later treated the incident as a misunderstanding and did not approve the appointment. Separately, aides and some White House officials privately discussed sidelining Makary earlier in the year but ultimately kept him in place.

What’s next: Agency leaders face pressure to stabilize leadership, reassure industry and the public, and clarify how any expedited review policies will preserve safety and scientific rigor.

As the FDA works to fill leadership gaps and steady its operations, observers inside and outside government will be watching whether reforms to review speed and personnel choices erode or preserve the agency’s reputation as a science-driven regulator.