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)
Source: Reuters
Published by GSM · USA (original Chinese edition)
Photo: 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).
