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

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.

Ferring Pharmaceuticals supports the Commissioner’s National Priority Voucher (CNPV) Pilot Program, provided that the FDA maintains its rigorous "gold standard" scientific and evidentiary requirements for all approved products. The company specifically argues against the approval of Pergoveris® under this program, citing insufficient clinical data, lack of US-specific testing, and a history of failed confirmatory studies.

The Association for Accessible Medicines (AAM) supports the Commissioner’s National Priority Voucher (CNPV) Pilot Program but argues that it should be expanded to include generic drugs and biosimilars. They advocate for formalizing the program's eligibility criteria and procedures through regulations and guidance to ensure transparency and accountability.

Carole O'Connell, a patient and consumer, opposes the CNPV Pilot Program due to concerns that it prioritizes political interests 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.

A patient and consumer is opposing the CNPV Pilot Program due to concerns that it prioritizes political goals over scientific rigor and safety. The commenter argues that the expedited review timeline lacks transparency and diverts the FDA's focus from its core mission of ensuring drug efficacy.

A patient and consumer opposes the CNPV Pilot Program, arguing that it prioritizes political goals over scientific rigor and safety. The commenter expresses concern that the expedited review timeline lacks transparency and diverts the FDA's focus from its core mission of ensuring drug efficacy.

Anne Zerrien-Lee, 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.

Amy Scott, a nurse and consumer, opposes the CNPV Pilot Program because she believes it prioritizes political interests over scientific rigor and safety. She argues that the expedited review timeline lacks transparency and could endanger patients by bypassing independent expert review.

The commenters, identifying as patients and consumers, oppose the CNPV Pilot Program due to concerns that it prioritizes political goals over scientific rigor and safety. They argue 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 due to concerns that it prioritizes political goals over scientific rigor and safety. The commenter argues that the expedited review timeline and the inclusion of drug pricing as a "national priority" undermine the FDA's independence and transparency.