Comment from Christine Morrissey

AnonymousOpposeIndividual
Summary: An individual is expressing strong opposition to the CNPV Pilot Program, arguing that it prioritizes political interests over rigorous scientific review. The commenter expresses concern that expedited timelines and the inclusion of non-FDA priorities like drug pricing will compromise patient safety and transparency.
Dear Acting Commissioner Diamantas, I strongly oppose the Food and Drug Administration’s (FDA's) Commissioner’s National Priority Voucher (CNPV) Pilot Program due to my concerns of politicization, safety, and lack of transparency. Americans rely on an FDA capable of rigorous drug reviews for safety and efficacy. In the past several months, the pilot program has taken steps that undermine the FDA’s transparency and that bow to political pressure, rather than expert review, in approving new medications. Expedited timelines for review pose dangers to consumers, while the inclusion of “national priorities” like drug pricing outside the agency's purview diverts the FDA’s focus away from safety and efficacy. The CNPV Pilot Program is a degradation of the safeguards that allow experts to review drugs independently of political influence. I am particularly concerned that the FDA aims to complete drug reviews within 1-2 months, when the typical timeline of 6-10 months, and without the same level of transparency. The rapid review endangers patients, while lacking clear communication regarding program implementation. If this pilot program moves forward, the FDA could continue its prioritization of approvals for drugs per political prerogative, without rigorous scientific scrutiny. Consumers deserve an FDA that puts safety and efficacy first, not political favors. I urge the FDA to discontinue the CNPV Pilot Program.

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