The US Food and Drug Administration (FDA) has raised the tropical disease priority review fee rate for fiscal year 2016 to about $2.73 million, which is effective from the beginning of next month through 30 Sept, 2016.
The new rate is about $200,000 more than last year's rate, but more than $2m less than the rate for fiscal year 2012. Back in 2008, FDA issued guidance for industry on tropical disease priority review, detailing the way in which the vouchers can be sold or transferred.
In 2014, Knight Therapeutics obtained a priority review voucher following the approval of its treatment for Visceral, Mucosal and Cutaneous Leishmaniasis, which the company then sold to Gilead for $125 million. In May, Sanofi paid Retrophin $245 million for a Rare Pediatric Disease Priority Review Voucher.
A priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of six months after the receipt or filing date, instead of the usual 10 months. Based on its set PDUFA goals, FDA committed to reviewing and acting on 90% of the applications granted priority review within this six month timeframe.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA is authorized to determine and collect the fees for certain applications using a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. The vouchers typically go to companies that gain approval for drugs to treat qualifying tropical diseases, including dengue, malaria, cholera, and most recently Ebola. And thanks to a recently passed law, FDA can add diseases to the list of eligible diseases to respond to emergencies and other concerns.
Applicants using a priority review voucher are entitled to a priority review but must pay FDA the priority review user fee and any other fee required by PDUFA.
The amount of the fee is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review that is not subject to priority review in the previous fiscal year.
FDA notes that for FY 2014, the standard cost, rounded to the nearest thousand dollars, for a new molecular entity new drug application (NME NDA) was $5.65 million and $5.53 million for a biologics license application (BLA). Based on these costs, the total cost to review the 48 applications in these two categories in FY 2014 (30 NME NDAs with clinical data and 18 BLAs) was about $269 million.
Twenty-nine of these applications (20 NDAs and 9 BLAs) received priority review. Using the FDA formula, the cost of a standard review for NME NDAs and BLAs is calculated to be about $4 million, and the cost of a priority review for NME NDAs and BLAs is about $6.7 million.