路透社：FDA 已搁置一至两个月快速审评试点，卫生部称工作仍在进行
据路透社11月12日独家报道，美国食品药品监管局（FDA）已事实上搁置「局长国家优先审评券」（CNPV）试点计划。这项计划承诺把部分新药与生物制品的审评压缩到一至两个月，报道援引六名消息人士与内部文件称，自前局长 Marty Makary 今年5月中旬离任后，FDA 没有再发出一张新券，负责审议的评审委员会已经停摆。
CNPV 试点于2025年6月由 Makary 宣布设立，面向五类国家优先事项：公共卫生危机应对、创新突破疗法、重大未满足医疗需求、供应链回流与可负担性。按 FDA 公布的数字与行业追踪，共有22个药品项目获得审评券，其中12个已获批、一例被拒，目前还有9个药物留在计划内。据路透社报道，FDA 仍在接收申请，但据一名知情人士称，已不再审议或发放新券，留在计划内的审评时间表改由 FDA 职业科学家接手管理。
美国卫生与公众服务部（HHS）发言人否认计划被搁置，称 CNPV 的工作「仍在进行」：FDA 职业人员继续评估已获券的申请、履行加速审评承诺，并总结试点经验。HHS 还表示，FDA 正在根据6月一场公开听证会的反馈改进试点，继续推进提高效率与加速科学审评的改革。Makary 离任后，FDA 局长一职至今没有常任人选。
同一篇报道还提到，FDA 公开完整回复信（CRL）数据库已约三个月没有新增条目，最近一封停在今年8月初。FDA 发言人对此表示，该局仍致力于主动公开经适当删节的完整回复信，并将继续发布。
这项快速审评试点自推出起争议不断：有国会议员质疑 FDA 推行该计划的法定授权，也有声音批评其透明度不足、占用审评资源。试点是停是续，将直接影响一批在研新药的上市时间表。
（来源：路透社）
Reuters: FDA Has Shelved Its One-to-Two-Month Priority Voucher Pilot; HHS Says Work Is Ongoing
The U.S. Food and Drug Administration (FDA) has effectively shelved its Commissioner's National Priority Voucher (CNPV) pilot program, Reuters reported exclusively on November 12, citing six sources and internal documents. The pilot promised reviews of certain drugs and biologics in as little as one to two months. No new vouchers have been awarded since former Commissioner Marty Makary resigned in mid-May, and the program's review council has gone dormant, according to Reuters.
The CNPV pilot was announced in June 2025 under Makary, covering five national priorities: public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience, and affordability. In total, 22 drug programs have received vouchers, with 12 approvals and one rejection to date, and nine drugs remain in the program. FDA is still accepting applications but is not reviewing or granting new ones, Reuters reported, citing one person familiar with the process, while FDA career scientists have resumed overseeing the review timelines of the drugs still in the program.
A spokesperson for the Department of Health and Human Services (HHS) disputed that the program had been shelved, saying work under the CNPV is 'ongoing': FDA career staff continue to evaluate applications granted a CNPV and meet commitments for accelerated review, and the agency is reviewing feedback from a June public hearing to refine the pilot. FDA has been without a permanent commissioner since Makary's departure in May.
Reuters and Fierce Pharma also reported that FDA appears to have paused publishing complete response letters (CRLs), with no new entries in its public database in roughly three months; the most recent entry dates to early August. An FDA spokesperson said the agency remains committed to the proactive release of appropriately redacted CRLs and will continue to publish them.
The pilot has drawn controversy since its launch, with critics citing political favoritism, limited transparency and strain on agency resources, and a member of Congress questioning FDA's statutory authority for the program. Whether the pilot resumes will affect the approval timelines of a pipeline of new drugs.
(Source: Reuters)
来源：路透社
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品监管局（FDA）总部大楼（固定图库联邦核心包）。 / Photo: Headquarters of the U.S. Food and Drug Administration (fixed federal-core asset-pack image).
GSM Global · 本篇英文版 English edition of this story
