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Richard Pazdur, MD, Named Acting Director of the FDA Oncology Center of Excellence

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U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement today regarding the appointment of 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 Richard Pazdur, MD, 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.”

ASCO President Daniel F. Hayes, MD, also commented on Dr. Pazdur's selection:

“ASCO commends FDA Commissioner Dr. Robert Califf for his selection of Dr. Richard Pazdur to lead the agency's new Oncology Center of Excellence. In his nearly 20 years with the FDA, Dr. Pazdur has worked innovatively to dramatically reduce the amount of time to review new products and increase the number of safe and effective oncology products available to cancer patients. He consistently demonstrates the necessary leadership and commitment to improving cancer care for directing this new center to carry out its mission.”

“ASCO applauds the remarkable success of the FDA in regulating oncology products. However, we believe a more coordinated approach will further streamline and organize evaluation of oncology products—both therapeutic and diagnostic. We have been supportive of calls for development of Centers of Excellence within the agency that globally review all aspects of a single disease, and we are pleased that Dr. Pazdur has been appointed to direct the oncology center. We are confident that this initiative will build on past success excellence and create a larger community of scientists and clinicians within the agency. The oncology center is coming at a crucial time in response to the need to coordinate review of drugs, diagnostic tests, and other types of devices. This large-scale agency reorganization will require a great deal of vision and planning to ensure that the new center fully achieves its goals of bringing safe and effective oncology products to market more efficiently. There is no better person to lead this effort than Dr. Pazdur.”

“ASCO is very supportive of the new FDA Oncology Center of Excellence and the selection of Dr. Pazdur to lead it. We are ready to work with Dr. Pazdur and the FDA as this new center is formed and works to meets the needs of people living with cancer.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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