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Regulatory Focus – Pazdur to Head New Oncology Center at FDA

Regulatory Focus – Pazdur to Head New Oncology Center at FDA

Vice President Joseph Biden on Wednesday named the US Food and Drug Administration’s (FDA) top oncologist, Dr. Richard Pazdur, to head the newly formed Oncology Center of Excellence (OCE).

The OCE is intended to accelerate the development of new oncology products, as part of Biden’s $1 billion dollar cancer “Moonshot” initiative, by working with FDA’s other centers for drugs, biologics and medical devices to promote a “cross-center” approach to reviewing oncology products.

“This new center will be a place where the combined skills of regulatory scientists and reviewers with oncology clinical expertise in drugs, biologics, and devices will come together to support an integrated approach to the advancement of cancer treatment,” Pazdur wrote on FDA’s blog.

“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,” FDA Commissioner Robert Califf said.

For years, Pazdur has been a mainstay of FDA’s oncology program. After joining the agency in 1999, Pazdur has served as the director of the Office of Hematology and Oncology within the Center for Drug Evaluation and Research (CDER) since the office was formed in 2005.

Despite facing criticism over FDA’s approach to reviewing cancer drugs in the past, Pazdur has been hailed as a reformer in recent years, and is credited with achieving faster approvals for cancer drugs after his wife, Mary Pazdur, was diagnosed with ovarian cancer in 2012 and died last November.

Over the past few years, the time to approval for cancer drugs has shrunk from an already accelerated six months down to an average of five months. While some have attributed this in part to Pazdur’s increased willingness to accept risk in approving cancer drugs, the decrease in review times also coincides with the creation of FDA’s breakthrough therapy designation.

In his new role, Pazdur will report to the FDA Commissioner as the OCE’s acting director during a roll out of the new center.

The announcement comes just weeks after a group of 28 cancer groups, including the nonprofit Friends of Cancer Research (FOCR), sent a letter to FDA calling for the agency to create such a center to oversee all oncology products. “An FDA Oncology Center of Excellence is a necessary step not only to streamline processes, but to further innovation and collaboration toward curing cancer,” said FOCR founder Dr. Ellen Sigal, adding that Pazdur “is the perfect pick to lead the FDA Oncology Center of Excellence.”…