STAT+: FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program

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Source: STAT News

Original: https://www.statnews.com/2026/02/03/fda-commissioner-marty-makary-addresses-staf...

Published: Tue, 03 Feb 2026 22:23:56 +0000

FDA Commissioner Marty Makary tried to calm employee concerns about the controversial expedited drug review voucher program at a staff town hall. A program called the Commissioner's National Priority Voucher (CNPV) was launched in June 2025 and allows the review of medicines to be shortened to 1-2 months instead of the usual 10-12 months. FDA staff have expressed concerns about the lack of transparency, potential political influence and the burden on workers. 15 coupons have been awarded by November 2025 and a total of 18 by January 2026, including drugs for cancer, sickle cell disease, obesity, hearing loss and infertility. Companies must demonstrate compliance with national priorities, such as addressing health crises, innovative medicines, domestic production or increasing accessibility. At a meeting in August, FDA officials acknowledged strong interest from companies and an unexpected number of applications. The program is a pilot program and has not been approved by Congress, drawing criticism from lawmakers.[1][2][3][4][6]