In a pre-publication notice today, FDA announced the FY 2021 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 $1,360,879 and remember that is to be paid on top of the $2,875,842 applications user fee with clinical data or $1,437,921 without clinical data. So, in for a penny, in for a pound, to the tune of up to $4,236,721 to use the voucher.
These vouchers are awarded for gaining approval of a new tropical disease product, a new pediatric product, or a new medical countermeasure, for which there is no previous approved treatment and for which there could be life-threatening consequences from the disease or exposure. The fees in FY 2020 for use of the priority voucher was $2,167,116. Quite a bargain this FY! The prepublications announcing the fees and the basis for their calculations can be found here, here, and here.
