The voucher program for rare pediatric diseases and tropical diseases was established to encourage firms to develop drug products for both of these categories. The voucher is awarded when such an NDA is approved, and that voucher can be used on another NDA by the same company or transferred (sold) to a third party to use on any other NDA products. The voucher, when redeemed, entitles the voucher holder to a 6-month expedited review. Many of the vouchers have been sold for hundreds of millions of dollars.
Sounds like a great deal? Well, it is, if you have a potential blockbuster drug you want to get to market quickly and have great data. However, one must remember that there is an additional fee for use of the priority voucher, which is in addition to the PDUFA fee that is in effect at the time of submission.
For FY 2018, the rare pediatric disease and tropical disease priority review fee rate is (according to a Wednesday Federal Register notice) $2,830,579. The fee represents the FDA calculation of the difference between the Agency costs of a standard 10-month review vs that of a 6-month priority review. So, the out-of-the-starting-gate costs for NDA submission for submission of an NDA with clinical studies accompanied by a priority review voucher is $2,830.579 + $2,421,495 or $5,252,074.
Thinking of purchasing a priority review voucher? You better have your number crunchers do their homework, as the cost of buying the voucher and the initial NDA fees could be up to 1/3 or more of the product development costs. It better be one heck of a moneymaker, or the price you charge might need to be quite high, if the volume is projected to be low. With the scrutiny on drug pricing, you may be buying yourself a public relations nightmare!
Both Federal Register notices announcing the fees can be found here and here.
