FDA published a Federal Register Notice today (July 31, 2015) announcing GDUFA fees for Fiscal Year 2016 (October 1, 2015 to September 30, 2016). The new fees are tabulated below together with fees from prior years for comparison.
Inflation adjustment of the original total GDUFA annual fee collection of $299 million now brings the annual total for FY 2016 to $318.4 million.
The facility fees for both API and FDF facilities remain relatively constant perhaps indicating that new facilities being added by first time filers are in balance with facilities no longer referenced in applications.
The big surprise is application fees. The DMF Filing Fee has risen 58%, from $26,720 to $42,170 after being relatively stable for the first 3 years of the Program. The ANDA Filing Fee has risen almost 30% to $76,030 from $58,730. The ANDA fee has been effected by the huge number of filings in June of last year to beat the 3 batches rule coming in which was understandably followed by a dearth of ANDA filings in the following months. However there is no such simple explanation for the DMF fee change, it seems that there are just fewer DMFs being filed.
