Surprise Leadership Appointment at FDA
The U.S. Food and Drug Administration announced an unexpected leadership change on November 11, naming Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research (CDER). This appointment places the longtime oncology leader at the helm of the division responsible for overseeing the vast majority of prescription medications in the United States. FDA Commissioner Marty Makary, M.D., praised Pazdur as a “renowned regulatory innovator” whose expertise will guide the agency through critical regulatory reforms.
Pazdur’s Distinguished FDA Career
26 Years of Oncology Leadership
Richard Pazdur brings over two decades of regulatory experience to his new role. As a 26-year veteran of the FDA, he has become one of the most influential figures in cancer drug development and regulatory review processes. His towering presence within the agency stems from his role as the founding director of the FDA’s Oncology Center of Excellence, established in 2017 to streamline cancer therapy development.
Surviving Leadership Changes
Pazdur stands out as one of only two center leaders who retained their positions following the significant leadership reorganization under the current Trump administration. This continuity demonstrates the agency’s recognition of his invaluable institutional knowledge and expertise. For now, he will maintain dual responsibilities, continuing to lead the Oncology Center of Excellence while the Department of Health and Human Services searches for his successor.
Transition Following Tidmarsh’s Resignation
Pazdur assumes control from George Tidmarsh, M.D., Ph.D., who resigned approximately one week before this announcement. Tidmarsh’s departure occurred amid an internal investigation examining allegations of misusing regulatory authority for personal purposes. The former CDER director had only held the position since July, joining after extensive experience in biotechnology and academia.
Previous Leadership Transitions
Tidmarsh had replaced acting director Jacqueline Corrigan-Curay, M.D., who served on an interim basis following Patrizia Cavazzoni, M.D.’s departure at the beginning of 2025. This rapid succession of leadership changes underscores the challenges facing the drug regulatory division during this transformative period.
Revolutionary Cancer Drug Development Programs
Project Orbis: International Collaboration
During Pazdur’s tenure leading the oncology division, the FDA launched several groundbreaking initiatives. Project Orbis enables concurrent submission and review of oncology products among multiple international regulatory agencies, significantly accelerating global access to cancer treatments. This innovative approach has transformed how pharmaceutical companies navigate international approval processes.
Project Equity and Diversity Initiatives
Project Equity, designed to promote diversity in cancer clinical studies, represented another ambitious program under Pazdur’s leadership. However, this initiative was recently shelved as part of broader rollbacks of diversity programs across federal agencies under the Trump administration.
Emphasis on Clinical Trial Standards
Overall Survival as Critical Endpoint
Under Pazdur’s guidance, the FDA has increasingly emphasized overall survival data as a fundamental endpoint for evaluating both efficacy and safety of cancer therapeutics. This shift reflects a more stringent approach to evidence requirements, ensuring that approved medications demonstrate meaningful clinical benefits for patients.
Tighter Accelerated Approval Controls
The FDA has implemented more rigorous oversight of accelerated approvals for cancer drugs. The agency now requires that confirmatory trials be underway as a prerequisite for granting these expedited approvals. This policy change addresses concerns about drugs receiving market authorization based on preliminary evidence without adequate follow-up validation.
Notable Controversies During Tenure
Pazdur’s leadership has not been without controversy. The high-profile rejection of Innovent Biologics’ PD-1 inhibitor Tyvyt, partnered with Eli Lilly, occurred because applicants relied exclusively on China-based clinical data. More recently, sources indicate Pazdur influenced the FDA’s unexpected complete response letter to Replimune’s oncolytic virus candidate for melanoma treatment, surprising industry observers.
Circumstances Surrounding New Appointment
According to The Washington Post, Pazdur initially declined the CDER director position. However, Commissioner Makary and other senior officials persuaded him to accept the role, citing sources familiar with the situation. In his November 11 statement, Pazdur expressed honor at leading CDER during a period of significant regulatory reform, emphasizing his commitment to advancing drug development alongside the medical experts assembled by Makary.
Immediate Challenges Ahead
Sarepta Therapeutics Decision Looming
Pazdur faces an immediate and difficult decision regarding Sarepta Therapeutics’ Duchenne muscular dystrophy drugs—Vyondys 53 and Amondys 45—which recently failed confirmatory trials. The accelerated approvals for these medications previously created significant controversy for former CDER director Janet Woodcock, M.D., with critics considering this decision a blemish on her otherwise distinguished FDA career.
Tidmarsh Investigation Fallout
The circumstances surrounding Tidmarsh’s departure add complexity to Pazdur’s transition. Tidmarsh told The New York Times he believed the FDA targeted him for raising concerns about the agency’s new national priority review voucher program. Managing the fallout from this investigation while maintaining CDER’s operational integrity presents additional challenges.
Looking Forward: Implications for Drug Development
Pazdur’s appointment signals continuity in oncology regulatory policy while potentially bringing that expertise to the broader pharmaceutical landscape. His track record of innovation, combined with heightened standards for clinical evidence, suggests CDER may pursue more rigorous drug evaluation processes across all therapeutic areas. The pharmaceutical industry will watch closely as Pazdur shapes regulatory policy affecting prescription medication development nationwide.
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