FDA Stalwart Pazdur Named Tidmarsh’s Replacement as CDER Director

Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.

Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.

The appointment of Richard Pazdur, currently director of the FDA’s Oncology Center of Excellence, comes less than a week after he reportedly declined the post, and just nine days after his predecessor’s controversial exit.

After 26 years in ascending cancer leadership roles at the FDA, Richard Pazdur will take the helm as the agency’s chief drug regulator.

Pazdur, currently director of the FDA’s Oncology Center of Excellence, was appointed as director of the Center for Drug Evaluation and Research, according to an announcement by the Department of Health and Human Services late Tuesday afternoon.

“Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process,” FDA Commissioner Marty Makary said in a statement accompanying the news release.

“I’m honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms,” Pazdur said in the same release. “I look forward to working closely with Dr. Makary and the medical experts he’s assembled to help our country reach its peak in drug development.”

The announcement comes less than two weeks after former CDER director George Tidmarsh was ousted from the role amid a probe into his “personal conduct” at the agency. Tidmarsh was placed on administrative leave days before. Tidmarsh appeared to have second thoughts about his decision to resign, however, conveying remarks to a meeting of senior staffers at the FDA’s Office of New Drugs that he was not resigning.

Pazdur’s appointment also comes less than a week after reports circulated that the longtime administrator had turned down the post. Deputy CDER Director Mike Davis met with Pazdur and FDA Commissioner Marty Makary on November 3, according to The Pink Sheet, which first reported that Pazdur declined the role, but it is not clear what they spoke about.

Pazdur first came to the FDA in 1999 to lead the agency’s Division of Oncology Drug Products and later became the founding director of the Oncology Center of Excellence when it was established in 2017. He will continue to also serve in this role until a successor is found, HHS said Tuesday.

Heather McKenzie is senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Also follow her on LinkedIn.
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