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

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.

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.

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.

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.

The commenter is an individual demanding the approval of ANKTIVA to save lives and improve the U.S. biosector. They argue that the agency is prioritizing pharmaceutical profits over patient needs and call for faster regulatory action.

Salvatore Capuccio, writing as a patient and consumer, opposes the CNPV Pilot Program due to concerns over political influence and a lack of transparency. He argues that the expedited review timeline compromises drug safety and efficacy by prioritizing political goals over rigorous scientific scrutiny.

Celia O'Kelley, 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 diverts the FDA's focus from its core mission of ensuring drug efficacy.

Barbara Briley, 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.