The FDA's top drug regulator submits his resignation to the agency [View all]

Source: Politico

12/02/2025 02:22 PM EST


Rick Pazdur, the FDA’s top drug regulator, told staff Tuesday he submitted his resignation to the agency, an abrupt departure weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval, according to four people familiar with the decision granted anonymity to discuss the move.

The decision — which comes days after top vaccine regulator Vinay Prasad said the agency would ratchet up regulatory requirements for new vaccines — is almost certain to raise new questions about Makary’s leadership of the FDA. Pazdur in recent weeks clashed with Makary over the Commissioner’s National Priority Voucher program, according to media reports.

That program — which aims to speed final review of drugs that address health priorities, pose a transformative innovative impact, address an unmet medical need, help onshoring efforts or increase affordability — was also criticized by Pazdur’s predecessor, George Tidmarsh. FDA experts have worried the involvement of political appointees in the process of choosing which firms receive a voucher could raise questions about the program’s integrity.

STAT first reported the news of Pazdur’s decision to retire.

Read more: https://www.politico.com/news/2025/12/02/the-fdas-top-drug-regulator-submits-his-resignation-to-the-agency-00672818