Overview
- Pazdur was named director of the FDA’s Center for Drug Evaluation and Research, which oversees most prescription and over-the-counter medicines.
- He joined the FDA in 1999 and founded the Oncology Center of Excellence in 2017, and he will remain OCE director until a successor is chosen.
- He succeeds George Tidmarsh, who left after federal ethics lawyers began reviewing concerns about his conduct as a lawsuit from Aurinia Pharmaceuticals alleged a personal vendetta and defamatory statements.
- He inherits Commissioner Marty Makary’s modernization push, including a voucher program intended to review designated national-priority drugs in one to two months.
- CDER has shed more than 1,000 staff over the past year and faces low morale, while Pazdur’s history of faster cancer-drug approvals based on early endpoints has drawn criticism from academics including Dr. Vinay Prasad.