Comment from Amy Scott

Dear Acting Commissioner Diamantas, As a nurse, patient, and consumer, I write to express my opposition to the Food and Drug Administration’s (FDA's) Commissioner’s National Priority Voucher (CNPV) Pilot Program due to concerns about politicization 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, bowing to political pressure, rather than observing expert review, in new medication approvals. The expedited timeline for review poses dangers to consumers, and the questionable inclusion of “national priorities” outside the agency's purview, diverts the FDA’s focus away from safety and efficacy. The CNPV Pilot Program is another blow to the safeguards that allow experts to review drugs independently of political influence. I am very concerned that the FDA aims to complete drug reviews within 1-2 months, compared to the typical timeline of 6-10 months, without the same level of transparency. This rapid review endangers patients and lacks the clear communication consumers deserve about program implementation. If this pilot program moves forward, the FDA could continue to prioritize approvals for drugs at the whim of a political prerogative, without the same level of scientific scrutiny. Consumers deserve an FDA that puts safety and efficacy first, not political priorities. I urge the FDA to discontinue the CNPV Pilot Program. Sincerely, Amy Scott WV 24934