Statement from FDA Commissioner Robert Califf, M.D. announcing the acting director of the FDA Oncology Center of Excellence

The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence (OCE). The OCE will expedite the development of novel combination products and support an integrated approach to tackle this devastating disease that touches so many American families.

Establishing a Center of Excellence in a disease as complex as cancer requires a thoughtful approach and we recognize that the framework of the OCE will evolve. At the same time, we remain committed to the sense of urgency that is central to the Cancer Moonshot. That is why we determined the best way to accelerate the formation of the OCE without disrupting the ongoing work within the FDA’s centers would be to appoint an internal leader in an acting capacity who can focus on bringing together oncologists across the FDA.

After a competitive internal search, I can think of no one more qualified to shepherd the agency into a new era of regulation over oncology products than the FDA’s own Dr. Richard Pazdur, who has led the FDA for nearly 20 years in reshaping and modernizing the review of cancer treatments.

Dr. Pazdur is the person the FDA needs to get the OCE up and running, because of his in-depth understanding of the inner workings of the FDA, his deep expertise in treating this complex disease and his ability to move the agency forward in this complicated task.

However, to be successful, we must leverage thought leaders inside and outside the agency in determining the design and implementation of the OCE. As such, center directors from the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) will work alongside Dr. Pazdur in his role as OCE acting director to formalize an innovative, yet seamless cross-center regulatory approach to enhance the coordination of clinical review across oncology-related drugs, biologics and medical devices.

The acting director of the OCE will also play a critical role serving as the central point of engagement for oncology stakeholders, including patient-focused advocacy groups, professional associations, industry, academia and sister agencies such as the National Institutes of Health. One of Dr. Pazdur’s charges in his acting role will be to facilitate and streamline this engagement and collaboration.

We look forward to Dr. Pazdur’s and the center directors’ work to lead the FDA in rapidly implementing the cross-cutting efforts of the OCE in this initial phase.