Today’s prepublication of the Federal Register (FR) contains the fees to be assessed for three priority review vouchers, namely the material threat medical countermeasure (MCM) priority review voucher; the rare pediatric disease priority review voucher, and the tropical disease priority review voucher. These fees were announced in three separate FR notices (here, here, and here).
These vouchers are awarded to sponsors that submit and gain approval for an NDA or BLA for one of the categories of voucher types. Once the NDA/BLA approval is secured, a voucher may be used by the applicant for a future application, or it can be sold to another applicant for their use. The voucher provides for a six-month priority review of an application submitted with a priority review voucher for any NDA or BLA.
While the use of the voucher is not cheap (the FY 2022 fee is $1,266,651), it provides for a four-month shorter review goal and, if the proposed product has a significant projected market value, four months of sales could be substantial. Remember that the voucher use fee is on top of the PDUFA NDA application fee (for FY 2022, that is $3,117,218). However, unlike, the prices for most things, such as lumber, food, and cars, which have been skyrocketing during COVID the last eighteen months, the fee for the priority voucher has declined substantially for the fourth straight year (see chart below).
|Fiscal Year||Priority Voucher Use Fee|
Firms have purchased priority reviews for as much as $350 million dollars so their value can be translated into instant cash on the books for the firms to which they are awarded. The priority review voucher program is very interesting. You can read the GAO’s 2020 assessment of the program here.