Comment from Pamela Lowry

Dear Acting Commissioner Diamantas, I am writing to strongly oppose the Food and Drug Administration’s (FDA's) Commissioner’s National Priority Voucher (CNPV) Pilot Program over concerns of politicization and lack of transparency. Americans rely on an FDA capable of rigorous drug reviews for safety and efficacy. Yet in the past several months, your pilot program has taken steps that undermine the FDA’s transparency and bow to political pressure, rather than expert review, in approving new medications. The expedited timeline for review poses dangers to consumers, and the inclusion of “national priorities” like drug pricing outside the agency's purview diverts the FDA’s focus away from safety and efficacy. Your Pilot Program would be yet one more blow to the safeguards that allow experts to review drugs independently of political influence. I am especially concerned that the FDA aims to complete drug reviews within 1-2 months, compared to the typical timeline of 6-10 months—all without the same level of transparency in addition to the lack of time for proper scientific review. This 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. We deserve an FDA that puts safety and efficacy first, not political priorities. I urge the FDA to discontinue the CNPV Pilot Program. Sincerely, Pamela Lowry CO 81503