FDA's Richard Pazdur to Retire, Triggering Leadership Upheaval
Richard Pazdur, the recently appointed director of the FDA's Center for Drug Evaluation and Research (CDER), has filed paperwork to retire at the end of December, just weeks after accepting the role. This sudden development adds to the ongoing leadership turmoil at the agency and raises concerns about regulatory stability in the pharmaceutical industry.
Pazdur's Brief Tenure and Unexpected Departure
Pazdur, a 26-year veteran of the FDA and founding director of the Oncology Center of Excellence, was named CDER director on November 11, 2025. His appointment was widely seen as a stabilizing move for an agency that has experienced significant upheaval during President Donald Trump's second term, including extensive layoffs, leadership changes, and review delays.
According to multiple sources, Pazdur informed CDER leadership of his retirement intentions at a meeting on Tuesday. An FDA spokesperson confirmed the news, stating, "We respect Dr. Pazdur's decision to retire and honor his 26 years of distinguished service at the FDA."
Implications for FDA Leadership and Drug Regulation
Pazdur's impending departure raises questions about the future direction of CDER and the FDA's ability to maintain its current pace of progress. The agency has faced criticism for its handling of drug approvals and rejections, as well as for a new voucher program that some lawmakers have described as a tool of "political favoritism."
RBC Capital Markets analyst Brian Abrahams commented on the situation, writing that Pazdur's retirement is a "significant, sudden and surprising turn" that "raises concerns over the future direction" of CDER. Abrahams added that the departure of this well-respected leader "adds uncertainty and is a net negative for most of the sector."
The sudden leadership change has also sparked speculation about FDA Commissioner Martin Makary's position, with Abrahams suggesting it "would not be unreasonable" for Makary's tenure to be "on shaky ground."
Industry Impact and Market Response
The news of Pazdur's retirement has had an immediate impact on the biotech sector. The S&P biotech index (XBI) fell slightly following the announcement, despite having risen 7% since Pazdur's appointment as CDER director on November 11.
The pharmaceutical industry now faces uncertainty regarding the regulatory landscape, with questions about who will succeed Pazdur and how this change might affect ongoing initiatives to streamline drug approvals and development processes.
As the FDA navigates this latest challenge, stakeholders across the healthcare and pharmaceutical sectors will be closely watching for signs of how the agency plans to maintain stability and continue its mission of ensuring safe and effective medications reach patients in a timely manner.
References
- Pazdur To Retire Weeks After Taking On Coveted FDA Role
Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.
- Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
- Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
- Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
- CDER head Richard Pazdur set to retire shortly after appointment
Weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., has taken steps to retire as head of the FDA’s Center for Drug Evaluation and Research at the end of this month.
- CDER head Richard Pazdur set to retire shortly after appointment
Weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., has taken steps to retire as head of the FDA’s Center for Drug Evaluation and Research at the end of this month.
Explore Further
What are the potential short-term and long-term impacts of Richard Pazdur's retirement on the FDA's Center for Drug Evaluation and Research (CDER)?
Who are the possible candidates to succeed Richard Pazdur as the director of CDER, and what qualifications might they need for the role?
How has the FDA's leadership turmoil during President Trump's second term affected the agency's regulatory effectiveness and industry confidence?
What specific initiatives or programs under Richard Pazdur's leadership, such as the voucher program, might be affected by his retirement?
What actions can the FDA take to address concerns over regulatory stability and maintain the trust of the pharmaceutical and biotech sectors during this transition?