Dr. Richard Pazdur, long a successful and influential veteran of the FDA, has clearly moved into very new territory. He is currently director of the Center for Drug Evaluation and Research (CDER), the agency’s largest and most important unit. His appointment comes on the heels of the removal of former director Dr. George Tidmarsh. Dr. Tidmarsh exited amid an active ethics complaint that had already cast doubt on his behavior while in office.
Dr. Pazdur has spent his 26 years at the FDA on oncology. He’s perhaps most famous for his long tenure managing the state’s cancer drug regulation. His leadership is needed at this critical time for CDER. The organization is suffering under crushing employee morale, return to office orders and ongoing turf battles with other FDA centers. Dr. Tidmarsh and Dr. Pazdur served as business partners at multiple pharmaceutical corporations during Dr. Tidmarsh’s career. This personal history made their professional relationship particularly fraught.
A complaint for professional ethics has indeed been filed against Dr. Tidmarsh. It alleges that he abused his authority at the FDA to exact retribution on the chairman of a Canadian drug manufacturer’s board of directors. While Dr. Tidmarsh claimed publicly to be innocent of any wrongdoing in media interviews, the news of these allegations forced him to resign from the post. High-profile FDA Commissioner Marty Makary recruited him to lead the agency’s hub de CDER. He can do little to maintain confidence in the center’s leadership.
Dr. Pazdur’s new role will be about helping them chart a course through that complex organization. In recent times, it has floundered with divisive internal discord and leadership uncertainty. He will be expected to stabilize operations at CDER and improve employee morale as it transitions back to in-person work amid ongoing adjustments to workplace policies. The center has faced criticism for its handling of various drug evaluations and its interactions with other parts of the FDA, making Dr. Pazdur’s leadership crucial for its future direction.
