Rick Pazdur, the US Food and Drug Administration’s top drug regulator, submitted his resignation after recently assuming leadership of the Center for Drug Evaluation and Research. Pazdur, a 26-year agency veteran and founding director of the Oncology Center of Excellence, had agreed to take the role after Commissioner Marty Makary assured him of operational autonomy and the ability to rehire staff. Media reports noted that Pazdur had recently disagreed with Makary about the Commissioner’s National Priority Voucher program, which is designed to accelerate final review of drugs addressing health priorities, innovative therapies, unmet medical needs, onshoring goals, or affordability and had also drawn criticism from former CDER leader George Tidmarsh. FDA experts have expressed concern that having political appointees participate in selecting voucher recipients may prompt questions about the integrity of the program.

The decision came days after top vaccine regulator Vinay Prasad said the agency would increase regulatory requirements for new vaccines. The decision is expected to prompt additional questions about Makary’s leadership of the FDA. Pazdur has 30 days to change his decision, and it remains unclear whether his decision is final.

The drug center has experienced four leadership changes this year. Patrizia Cavazzoni left for a senior role in industry, Jacqueline Corrigan-Curay retired after serving in an acting capacity, and George Tidmarsh resigned in November following allegations of misuse of his position. Makary’s recruitment of Pazdur was intended to stabilize the center after these departures.

Source: Politico