A Fee that can Choke a Horse – But worth it!

FDA announced the fees for the Rare Pediatric Disease Priority Voucher and the Tropical Disease Priority Review Voucher in the Federal Register (here)  and (here).  These vouchers can be used to obtain priority review for another NDA or biologic application (BLA), or the vouchers can be sold to another sponsor to use as they see fit.  Voucher sales have topped $300 million in the past.  The fees for 2016 for each of these programs to file the NDA is $2,706,000 (up from $2,562,000 for the 2015 cohort year (see previous post here) – note FDA cannot yet calculate the fee using the 2016 cohort year costs because the cohort year has not closed).

Both programs are designed to bring certain medicines to market for rare pediatric diseases and topical diseases more quickly by incentivizing the NDA sponsor with the priority review voucher. In addition to the fees for these voucher reviews, the sponsor must also pay the standard PDUFA user fee of $2,038,100, thus, a firm is out of the gate for $4,744,100, none of which is refundable or waivable under the program.  In that regard, success is the only option.  But if a voucher helps bring a potential billion-dollar drug to market in 6 months, or aids a firm in beating the competition to market, or brings a first in class or a drug with a significant medical benefit to patients sooner that is not eligible for priority review, then apparently it is well worth the costs.  The only question is how much will the next voucher bring at the auction block.