Over the last eight months, a number of priority vouchers were sold by firms that were subject to the award of either a tropical disease priority review voucher, a rare pediatric disease priority review voucher, or a material threat medical countermeasure (MCM) priority review voucher. The purchase prices of these vouchers, while not as high as the one sold by United Therapeutics to AbbVie for $350 million in 2015, are still substantial. Abeona just sold its priority review voucher for $155 million and, since November, Zevra Therapeutics, Acadia Pharmaceuticals and PTC Therapeutics all sold vouchers for $150 million, while Ipsen got slightly more, at $158 million, in a deal last August” (see the May 12, 2025 Biopharma Dive article by Ben Fidler here).
The use of a priority review voucher compresses the ten-month review clock to six months, which can be a major advantage for an applicant, especially for a potential blockbuster or if there is a competition between two companies for a similar product because getting to the finish line of the approval process earlier, with only a single treatment on the market, can result in a huge financial benefit.
Certainly, the sale of a priority review voucher adds to the bottom line of the seller, but for the purchaser there are additional expenses associated with the use of a priority review voucher. For instance, in addition to the PDUFA user fee for FY 2025, which stands at $4,310,002 for an application with clinical data and $2,155,001 for an application without clinical data, there is an additional Priority User Fee of $2,482,446 for a total use fee of $6,792,448 or $4,637,447 at time of submission. If all goes well and you do get a six-month approval and your product hits blockbuster status, then good for you. But if your product fails to gain approval or, if approved, does poorly in the marketplace, then you may be looking for a new job as your administrative application fees for just the submission are the $6.8 or $4.6 million plus the amount for which you bought the priority review voucher. Well, you know what they say—“big risk, big reward!
