FDA's Two-Month Drug Voucher Pilot Stalls; HHS Says It's Still Running

FDA leadership has told companies the Commissioner's National Priority Voucher program is not moving forward, Reuters reported Nov. 12, citing sources. Applications technically remain open, according to Pharmaceutical Technology's read of the report. HHS and FDA spokesperson Emily Hilliard disputed the framing, saying the pilot is ongoing and that the agency is reviewing feedback from a June public hearing to refine it. Nine drugs are still in the program, and career FDA scientists have reportedly taken over overseeing their review timelines.

Then-Commissioner Marty Makary launched the pilot in June 2025, dangling decisions within one to two months after a complete application — far faster than the usual 10 to 12. Vouchers went to drugs the agency judged as serving national priorities: addressing a U.S. health crisis, meeting unmet medical needs, lowering drug prices, expanding U.S. manufacturing. Reviewers examined each application simultaneously, then met for a one-day session. The first nine recipients, announced in October 2025, covered pancreatic cancer, type 1 diabetes, deafness, blindness, infertility, nicotine vaping addiction and a rare blood disorder, plus two older drugs picked to boost domestic manufacturing. 'We must modernize the review process and try new approaches to meet the needs of the American people,' Makary said at the time.

The program did deliver some speed. Twenty-two drugs received vouchers and 12 have been approved, including five since Makary resigned in May 2026, per Pharmaceutical Technology. The latest were Lipfendra and Revolution Medicines' pancreatic cancer drug Rasonque, approved Aug. 26. But timelines slipped repeatedly: four of the first seven voucher drugs missed their initial decision dates, Becker's Hospital Review reported in January, after Reuters uncovered review delays tied to safety and efficacy concerns. Merck KGaA's fertility treatment Pergoveris got its voucher under a drug-pricing agreement with the administration and still sat unapproved three months after the FDA accepted its final application.

Sanofi's Tzield, under review for expanded use in type 1 diabetes, became the flashpoint. Tracy Beth Hoeg, then the FDA's acting drug center director, raised safety concerns at three meetings between October 2025 and April 2026. The agency granted accelerated approval in June 2026, after she and Makary had both left. Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, called the design 'the worst of both worlds' — and because Congress never created it, an agency pilot is easy to reverse. No new vouchers have been awarded since Makary's departure, the executive council that oversaw reviews has gone dormant, and the FDA has had no permanent commissioner since May. An HHS spokesperson told Fierce Biotech that 'additional reforms initiated under the previous commissioner continue to move forward.'

The next move belongs to whoever runs the agency. Heidi Overton, nominated to lead the FDA, still needs a vote from the Senate health committee and the full Senate, and no formal notice has been issued ending or rebuilding the program. Drugs already approved through the vouchers stay approved and face the same safety monitoring as any other FDA-cleared medicine; priority review, breakthrough therapy designation and accelerated approval remain untouched. Henrik Johanning of Epista Life Science told Pharmaceutical Technology that shorter review windows shape how companies prep a launch, so plans built on the fast lane may need reworking. Upcoming decisions on the nine remaining drugs will reveal whether they are still on a one-to-two-month clock or a standard one.