FDA’s Pazdur Raises Concerns Over Legality of National Priority Voucher Program Amid Internal Disagreement

Recent reports indicate an internal disagreement at the FDA over the legality of the Commissioner's National Priority Voucher (CNPV) program, designed to expedite reviews for select drugs14.

Dr. Tidmarsh was reportedly placed on leave after raising concerns about the legal foundation of the CNPV program, a move he described as being linked to his whistleblowing1.

Dr. Pazdur, a prominent FDA leader, has also reportedly questioned aspects of the program’s legality, particularly regarding the new 'tumor board' review process—where agency leaders, rather than review staff, make approval decisions4.

The process for the first voucher drug approval excluded traditional FDA review staff, with decisions made by a select group of agency leaders, raising additional internal transparency and legitimacy questions4.

FDA maintains that the legal authority for the voucher program comes from the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA), insisting that all statutory and regulatory requirements still apply3.

As of late October 2025, there has not been a public FDA announcement regarding final approval decisions for the first group of voucher recipients, nor formal resolution of the internal dispute4.

Sources:

1. https://www.venable.com/insights/publications/fda-pulse/dr-pazdur-in-at-cder-leadership-developments

3. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program

4. https://www.statnews.com/2025/11/21/top-leaders-not-fda-reviewers-voted-on-first-priority-voucher-drug/