Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA

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Rick Pazdur’s appointment as director of the FDA’s Center for Drug Evaluation and Research (CDER) comes at exactly the right moment, both for the agency and for the patients it serves.

For more than two decades, I have watched Rick lead with clarity, urgency, and compassion. As the longtime head of FDA’s Oncology Center of Excellence, he redefined how the agency approaches cancer drug development, building a model of collaboration and scientific rigor that has transformed patient care. He is both a regulator and, in his own words, a “regulator advocate.”

That blend of purpose and pragmatism was shaped, in part, by personal loss. When Rick’s wife, Mary, passed away from ovarian cancer roughly a decade ago, it changed him profoundly (The Cancer Letter, Dec. 4, 2015). “I have a much greater sense of urgency these days,” he told The New York Times in 2016. That urgency has fueled a career defined by one constant: doing everything possible to get safe, effective treatments to patients faster.

An oral history interview with Rick and Mary Pazdur is available in the Cancer History Project, alongside an archive of related coverage. 

Rick steps into this new role at a critical time. The FDA has weathered leadership turnover, a prolonged government shutdown, and staffing levels that have fallen to those of nearly a decade ago. Yet through it all, the agency’s career staff have remained steadfast, upholding scientific integrity and public trust. They deserve the stability, clarity, and confidence that strong leadership brings, and that Rick embodies.

Under his guidance, CDER has an opportunity to strengthen FDA’s foundation while embracing the future. The agency must modernize how it evaluates biomarkers, validate emerging uses of artificial intelligence, and extend the cross-agency collaboration that has made oncology such a success story. These efforts, coupled with smarter and more inclusive clinical trials, will ensure the United States remains the world leader in medical innovation.

The promise of biomedical research has never been greater. Gene and cell therapies, targeted treatments, and digital technologies are changing what is possible. But realizing that promise requires an FDA that is not only strong and stable but also forward-looking and deeply human.

Rick Pazdur represents all of those qualities. His scientific integrity, empathy, and sense of urgency have guided him throughout his career. As he takes the helm of CDER, I am confident he will do what he has always done: stand up when the agency and patients need him most.

For the future of science and for every patient still waiting, that kind of leadership could not come at a more important time.

Ellen V. Sigal, PhD
Chair and founder, Friends of Cancer Research
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Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”
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Ellen V. Sigal, PhD
Chair and founder, Friends of Cancer Research

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