Well, here is a surprise! The price for the use of a priority review voucher in FY 2024 dropped about $210,000 from the 2023 fee. In a pre-publication notice today (here), the FDA announced the FY 2024 fee for the use of a Tropical Disease Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher, or a Material Threat Medical Countermeasure Priority Review Voucher. That fee is $1,314,206 for each type of voucher, and remember that is to be paid on top of the $4,048,695 PDUFA user fee with clinical data or $2,024,348 without clinical data.
The FY 2024 fee is the lowest since FY 2021, but using the voucher will still cost your company $5,362,901 to file a new NDA or BLA. Also remember that these vouchers, when awarded, can be used by the applicant that received the voucher for approval of the application but they can also be transferred (sold) to others. Some of the vouchers have recently sold for up to $110,000,000. If you are the purchaser, you best have a blockbuster drug to use it on!
