National priority vouchers: a year of reform?

The US Food and Drug Administration's (FDA) national priority voucher pilot has now run for more than a year. Announced in June 2025 as a way to cut drug review times to one or two months, it has produced 22 awards, nine approvals, one rejection, one sponsor asking to be removed, and a public hearing at which speakers asked whether the agency has the authority to run it at all.

Each voucher is nontransferable, tied to a single application, and expires two years after issue. Reviews run to a set sequence: a 60-day pre-submission period, a filing check of two to three weeks, then a target of 30 to 60 days for the review itself. A multidisciplinary panel, the Commissioner's National Priority Voucher (CNPV) review council, votes on a non-binding recommendation.