Priority review vouchers are awarded to the sponsors of applications for tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) products that gain approval. The new fee for use of a priority review voucher is the same for each type of voucher as identified in the table below:
The pre-publication Federal Register Notice (here) describes the process of how the FDA calculated the new fee for FY 2026. The previous year’s fee was $2,482,446, so if you have a priority review voucher you can save $519,974 by using it after September 30, 2025! It seems as though the FDA may be giving sponsors a break, but it’s more likely that the FDA estimates that more priority review vouchers will be utilized for eligible applications during FY 2026.
Remember, the fee for use of the priority review voucher is paid on top of the PDUFA user fee, which in 2026 will be $4,682,003 for an application requiring clinical data or $2,341,002 for an application that does not require clinical data (not sure whether there has been a priority review voucher used for an application without clinical data but I guess it may be possible). Also, remember that a voucher can be sold and resold, with most being sold for over $100,000,000, so having a voucher seems like a win for any firm. And what do you get for the use of a priority review voucher? You get a six-month FDA review of your application instead of a ten-month standard review. That six-month review, if it leads to approval, can equate to an enormous market advantage, especially for drug products that are likely to become blockbusters.
The fees are high but the rewards are most definitely greater!
