Outgoing FDA Commissioner Robert Califf, MD, has announced that Richard Pazdur, MD, who was serving as the interim director, will now be heading the Oncology Center of Excellence.
Outgoing FDA Commissioner Robert Califf, MD, has announced that Richard Pazdur, MD, who was serving as the interim director, will now be heading the Oncology Center of Excellence (OCE). The center was established in 2016 on the premise of having a coordinated clinical review of drugs, biologics, and devices across the agency’s 3 medical product centers and eliminate silos and parallel processing of what should essentially be a cohesive process.
The FDA is planning a restructure within the Office of Medical Products and Tobacco so it’s be better equipped to manage the needs of cancer patients. A press release from the FDA said that while the application and review process will remain the same, “Uniting experts to collaborate on the clinical review of oncology products will enhance the agency’s work in approving safe and effective cancer products.” The OCE is also expected to improve the process of stakeholder engagement as well as advance the agency’s oncology-related regulatory and policy issues. Â
As for funding, existing funds to the tune of $3.6 million will help establish OCE, according to The Cancer Letter, while the next 5 years are expected to route an additional $75 million, via the National Cancer Institute and the National Institutes of Health.
Speaking with The Cancer Letter last year, Pazdur said, “I’ve always had a vision to enhance collaboration and focus our work in oncology here at the FDA in disease-specific teams. That was one of the first things I did when I became the director of what was then the Division of Oncology Products in CDER [Center for Drug Evaluation and Research], and I think the OCE is a continuation of that across medical products.”
Cancer organizations are reacting warmly to the news. Clifford Hudis, MD, CEO of the American Society of Clinical Oncology, expects the OCE to create a bigger community of scientists and clinical experts within the FDA. “ASCO looks forward to working with the OCE and the new administration to help improve the lives of people living with cancer,” Hudis said.
The American Association for Cancer Research (AACR) also congratulated Pazdur on his appointment. “The AACR looks forward to working with Pazdur and his staff in the months and years to come, as they have worked for years to build collaborative partnerships with academia, industry, other government agencies, scientific societies, and patient advocacy organizations to improve both the pace and the quality of new cancer drugs reaching patients,” said AACR president Nancy Davidson, MD.