Posted 29 September 2016
By Zachary Brennan
The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year.
Tropical Disease Priority Review Voucher User Fee
The new rate is based on FDA's estimate that the cost of a standard review for new molecular entity (NME) new drug applications (NDAs) and biologic license applications (BLAs) will be about $3,977,000, while the cost of a priority review for NME NDAs and BLAs is about $6,642,000, meaning the agency thinks such costs will be slightly less in FY 2017 than FY 2016.
FDA's estimates are based on the costs FDA saw in FY 2015 when it reviewed 56 NDAs and BLAs. The total cost to review the 56 applications in FY 2015 (32 NME NDAs with clinical data and 24 BLAs) was $289,352,000, according to FDA.
Eleven PRVs have been awarded so far (including the latest to Sarepta) and five have been sold (including the one Gilead bought in 2016), with one selling for $350 million in August 2015 to AbbVie.
The rare pediatric disease and tropical disease PRV fees established in the new fee schedule must be paid for any application that is received on or after 1 October 2016, and must be paid in addition to any other fee due under the Prescription Drug User Fee Act (PDUFA).
In addition to the fee announcement, Congress this week passed a short-term extension to the pediatric PRV program so that it would not sunset at the end of September. Negotiations for another extension are ongoing.