BioCentury
ARTICLE | Politics & Policy

FDA lowers fee to use Priority Review voucher

September 13, 2012 1:10 AM UTC

FDA set the fee for companies to use a Priority Review voucher at $3.6 million for FY13, down from $5.3 million in FY12. The fee is adjusted each fiscal year to account for the difference between the average costs for FDA to conduct a Priority Review vs. a standard review. Congress established the voucher program through the FDA Amendments Act of 2007 to provide incentives for the development of treatments for tropical diseases (see BioCentury, Aug. 8, 2010).

FDA has awarded only one Priority Review voucher, to Novartis AG (NYSE:NVS; SIX:NOVN) on approval of malaria drug Coartem artemether/lumefantrine. Novartis applied the voucher to an sBLA for canakinumab for gouty arthritis. The agency subsequently issued a complete response letter for the sBLA (see BioCentury Extra, Aug. 29. ...