Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments

Jordan Despanie, PhD, advocates for the continuation and formalization of the Commissioner’s National Priority Voucher (CNPV) pilot program to enhance U.S. biopharmaceutical competitiveness and supply chain security. The commenter proposes a framework to transition the pilot into codified rulemaking that balances rapid regulatory review with scientific integrity through transparent criteria, a dual-track review process, and public auditing.

The Cystic Fibrosis Foundation supports the development of innovative therapies but urges the FDA to temporarily pause the CNPV pilot program to process stakeholder feedback and ensure consistent standards. They also recommend using the formal notice-and-comment process for future rules, increasing transparency in the selection process, removing political influence from the review council, and excluding pricing or manufacturing criteria from eligibility.

The diaTribe Foundation supports the goal of the Commissioner’s National Priority Voucher (CNPV) Pilot Program to expedite the approval of innovative therapies for unmet health needs. However, they recommend eliminating the CNPV Review Council to prevent political influence, conducting a workload study to ensure non-CNPV applications aren't delayed, and increasing transparency regarding selection criteria and patient involvement.

Merck & Co., Inc. supports the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program, noting that it successfully accelerates patient access through early structured engagement and rolling reviews without compromising regulatory rigor. The company argues that the program provides improved predictability for sponsors and demonstrates broad applicability for therapies with significant public health impacts.

The Cancer Innovation and Regulation Initiative in the Program On Regulation, Therapeutics, And Law (PORTAL), an academic research center based at Harvard Medical School and Brigham and Women’s Hospital, opposes the current design of the CNPV Pilot Program. They argue that the program risks politicizing regulatory decisions, eroding public trust, and imposing an unfunded mandate on FDA staff without meaningfully improving clinical development timelines.

Blood Cancer United opposes the Commissioner’s National Priority Voucher (CNPV) Pilot Program, arguing that it shifts drug approval decisions from independent career experts to political appointees. The organization expresses concern that this process lacks scientific rigor, invites political influence, and may lead to reduced insurance coverage for patients.

Viatris Inc. supports the Commissioner’s National Priority Voucher (CNPV) Pilot Program as a means to accelerate the review of drugs addressing national health priorities. However, the company requests that the FDA provide clearer guidance on eligibility, selection processes, and regulatory engagement to ensure the program complements existing expedited review mechanisms and is properly resourced.

Public Citizen, a national nonprofit consumer advocacy organization, opposes the Commissioner’s National Priority Voucher (CNPV) pilot program. They argue that the program lacks statutory authorization, uses non-scientific criteria for eligibility, imposes dangerously short review timelines, allows for inappropriate political interference, and was initiated without proper notice-and-comment rulemaking.

Ann Dorsey, a patient and consumer, opposes the CNPV Pilot Program due to concerns that it prioritizes political goals over scientific rigor and safety. She argues that the expedited review timeline lacks transparency and risks compromising the FDA's ability to independently evaluate drug efficacy.

A patient and consumer is opposing the CNPV Pilot Program, arguing that it prioritizes political goals over scientific rigor and safety. The commenter expresses concern that the expedited review timeline and the inclusion of non-FDA priorities like drug pricing will undermine the agency's transparency and independence.