Comment from Gary Andrew

Dear Acting Commissioner Diamantas, As a patient and consumer, 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, free from political pressure. Who do you represent? The American people, the Trump administration or the drug manufacturers? Yet in the past several months, the 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. The CNPV Pilot Program is another 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. 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, Gary Andrew NC 28036