Today, on the Federal Register’s pre-publication page, the FDA published the new fee that must be submitted for use of a priority review voucher. The notice (here) establishes the “FY 2027 priority review fee rate for use of tropical disease, rare pediatric disease, and material threat MCM priority review vouchers at $1,798,596” (the FY 2026 fee rate was set at $1,962,472) “and outlines FDA’s process for implementing the collection of priority review user fees. This rate is effective on October 1, 2026, and will remain in effect through September 30, 2027”. With the lower price tag for FY 2027, the voucher becomes almost a bargain!
Priority review vouchers are awarded to firms that develop and obtain approvals for a product for a rare tropical disease, a rare pediatric disease, or a material threat medical counter measure. Once awarded, the voucher can be used by the awardee for a priority 6-month review of another of its future applications or they can sell the voucher to another sponsor for their use.
The use of the voucher for obtaining a priority review in FY 2027 for NDA or BLA submission will also obligate the sponsor to pay the standard FY 2027 PDUFA user fee of $4,600,753 as well as the priority voucher fee of $1,798,596, resulting in a cumulative fee of $6,399,349. That certainly is a big bite of the apple and hopefully the application will gain approval. If not, then that just becomes an expensive gamble!
