Richard Padzur to depart FDA after recent CDER leadership change

Less than a month after being appointed as the head of the U.S. Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER), senior regulator Richard Padzur has decided to retire from the agency. He reportedly shared this decision with FDA colleagues on December 2, 2025. While there remains a possibility that Padzur could reverse his choice, the prevailing expectation is that he will step down by the end of the month.

Padzurs departure follows shortly after his appointment to lead CDER during a period marked by agency upheaval, including leadership reshuffles, layoffs, delays in drug approvals, and criticisms from former staff regarding the FDAs politicisation.

Should Padzur confirm his retirement, the FDA will need to identify a successor for both CDER and the Oncology Center of Excellence, which he established in 2017. John F. Crowley, president and CEO of the Biotechnology Innovation Organization (BIO), expressed concern over Padzurs exit, emphasizing that it underscores the need for stability in FDA leadership. Consistent turmoil threatens America's position in biotechnology, creating regulatory unpredictability, Crowley stated, noting that such instability could give an advantage to China in the pharmaceutical sector as international deals grow.

Padzur has been with the FDA since 1999, contributing significantly to streamlining oncology drug approvals and ensuring that robust evidence supports cancer therapies. He assumed the CDER leadership role following the resignation of former director George Tidmarsh, whose departure came amid an investigation into personal conduct concerns.

The FDA has experienced numerous leadership disruptions in 2025. In July, Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER), briefly left the agency before returning at the FDAs request. Earlier, Peter Marks resigned from his position at CBER due to conflicts with US Health Secretary Robert F. Kennedy Jr., particularly over vaccine policy, citing pressure to endorse misleading claims.

Padzurs exit highlights ongoing challenges for the FDA as it seeks to maintain scientific leadership, agency stability, and international competitiveness in biotechnology and pharmaceutical innovation.

Author: Harper Simmons