The US Food and Drug Administration has quietly halted its Commissioner's National Priority Voucher pilot program, Reuters reported Thursday. Launched in June 2025 under former Commissioner Marty Makary, the initiative aimed to compress final drug reviews from 10 to 12 months down to one or two months for products aligned with national priorities. According to internal agency documents, the executive council of political appointees overseeing those reviews has gone dormant. FDA leadership has told companies the program is not moving forward, though the application portal remains open without advancing submissions.
No new vouchers have been awarded since Makary resigned in May 2026, leaving the agency without a permanent commissioner. Across the program's lifespan, 22 drugs received vouchers and 12 won approval—including five cleared after Makary's departure—with several approvals accelerated by eight months or more. Two sources told Reuters that FDA career scientists have resumed overseeing review timelines for the nine drugs still active in the program.
The two most recently approved voucher drugs—Merck's cholesterol pill Lipfendra and Revolution Medicines' pancreatic cancer drug Rasonque—bypassed the political executive council entirely. Merck KGaA's fertility treatment Pergoveris remains unapproved three months after application acceptance. HHS spokesperson Emily Hilliard maintained the pilot is ongoing as officials review June public hearing feedback, while Endpoints News noted the FDA still contends the program remains active. Former HHS assistant secretary Rich Danker said the initiative is quietly being phased out.
Because the pilot required drugmakers to have manufacturing controls and quality systems inspection-ready ahead of filing, the sudden pause left sponsors scrambling. Epista Life Science Senior Vice President Henrik Johanning said: "When review windows shrink from 10 to 12 months to as little as 1 to 2 months, the entire model for launch readiness changes."
