Comment from Holly McDonald

Dear Acting Commissioner Diamantas: As an American taxpayer, patient, and consumer, I write to oppose fully the Food and Drug Administration’s (FDA's) Commissioner’s National Priority Voucher (CNPV) Pilot Program over serious concerns of politicization, and lack of the use of proper scientific protocols, transparency, and the trustworthiness of its results. Americans rely on a trustworthy FDA capable of rigorous drug reviews for safety and efficacy. Without fail, the FDA must transparently adhere to scientific protocols and truth telling about all results. Yet in the past several months, the pilot program has taken reckless steps that undermine the FDA’s transparency and bow to political pressure, rather than an expert review process, in approving new medications. The expedited timeline for review poses dangers to consumers. Moreover, 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. Again, I cannot stress enough the vital importance of scientific rigor, telling the truth about results, and trustworthiness throughout the review process. I am especially concerned that the FDA aims to complete expedited drug reviews within one to two months, compared to the typical timeline of six to ten months—all without the same level of transparency. This rapid review endangers patients and lacks the clear communication consumers deserve about program implementation. So, it is wholly unacceptable to the American people. Crucially, if this pilot program continues to move forward, the FDA recklessly will continue to prioritize approvals for drugs at the whim of a political prerogative, without the same previous level of scientific scrutiny. Such policy only presents a clear and present danger to American consumers, and places into question the efficacy of all drugs approved under this system. Consumers deserve an FDA that places safety and efficacy first, not partisan political priorities. Therefore, as an American taxpayer and consumer, I insist that the FDA not place public health at direct risk as a result of its folly through this politicized program and immediately discontinue the CNPV Pilot Program. Thank you for your consideration of my comment.