GDUFA Fees Rise – While Generic Firms are Getting Restless

FDA announced the Fiscal Year 2014 User Fees to begin on October 1, 2013 here.  This rise in fees was expected since the number of ANDA projected to be submitted in 2013 appears as if it may drop below the 1103 submitted in 2012.  In addition, the number of facilities self-identifying was slightly lower than anticipated.  Also remember that, in year one of GDUFA, there was $50 million of the $299 million permitted for 2013 associated with backlog fees to address the logjam of ANDAs in the backlog.  That was a one- time fee which must now be made up by increases in the ongoing yearly fees. 

The new FY 2014 fees and previous year fees are presented below:

ANDA Fee           $63,860 Compare to the FY 2013 fee of $51,520

PAS Fee              $31,920 Compare to the FY 2013 fee of $25,769

DMF fee              $31,460 Compare to the FY 2013 fee of $21,340

API Domestic      $34,515 Compare to the FY 2013 fee of $26,458

API Foreign        $49,515 Compare to the FY 2013 fee of $41,458

FDF Domestic    $220,152 Compare to the FY 2013 fee of $175,389

FDF Foreign       $235,152 Compare to the FY 2013 fee of $190,389

This rise in fees will likely cause many small generic firms to get very nervous, as the cost of doing business with the Office of Generic Drugs (OGD) is getting steeper and the pace of approvals is not yet picking up speed.  In addition, with median approval times staying at about 33-34 months, many small manufacturers with no approved products may be waiting three fee cycles prior to seeing their product approved.  We also hear discontent from many application holders, indicating that communications with OGD are not yet improving.   It is also still very difficult to obtain meetings with OGD.  Many firms were hoping for immediate signs of approval, which is a bit unrealistic, given the backlog OGD has accumulated over the years, but here we are almost a year into GDUFA and changes still are not very evident.  The generic industry knows that there are no metrics associated with OGD performance goals for the first two years of GDUFA; however,  the questions is, will the industry remain patient until the goals kick-in in for cohort year three application submission.  Still worries abound regarding applications that were in the original backlog and those ANDAs submitted in years 1 and 2 of GDUFA, especially if OGD will concentrate its efforts to meet the year three goal metrics.  With the potential of fees rising even more next year and no potential for changes to the GDUFA program until its first 5 year cycle is over in 2017, the industry will keep a close eye on performance and will likely keep the pressure on the Agency and Congress if things do not improve soon.