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

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.

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 representing the Huntington's disease community. They are requesting that the FDA fast-track life-changing treatments for Huntington's disease, which is a fatal neurological disorder with no current approved therapies.