Generic Drug User Fee Rates Announced – GDUFA II, Here We GO!

The generic drug user fees for year 1 of GDUFA II have been announced by FDA.  There are 2 fundamental differences in the GDUFA II fee structure relative to GDUFA I.  First, GDUFA I was built on the assumption of OGD receiving about 750 ANDAs per year.  The average number of ANDAs received over the 5-year GDUFA I period was just over 1000 ANDAs.  As a result, FDA adjusted fees to reflect the increased and unanticipated workload that was seen under GDUFA I.  Secondly, for the first time, FDA is collecting what is called a yearly Program Fee for generic drug applicants that is “supposed” to place relief on some of the fees for establishments and facilities.

The FY 2018 fees reported in the Federal Register notice (here) are as follows:

Fee Type Fee
ANDA $171,823
DMF $47,829
Domestic API Facility $45,367
Foreign API Facility $60,367
Domestic FDF Facility $211,087
Foreign FDF Facility $226,087
Domestic CMO Facility**** $70,362
Foreign CMO Facility**** $85,362
Large Size Company* $1,590,792
Medium Size Company ** $636,317
Small Company *** $159,079

*20 or more ANDAs

** Between 6-19 ANDAs

*** 5 or fewer ANDAs

**** The CMO facility fee is owed by each person who owns an FDF facility that is identified in at least one approved ANDA, but is not identified in an approved ANDA held by the owner of that facility or its affiliates.

How do these compare to the GDUFA I FY 2017 fees?  See chart below

Original ANDAs $70,480

PASs                    $35,240

DMFs                  $51,140

API domestic     $44,234

API foreign         $59,234

FDF domestic    $258,646

FDF foreign        $273,646

Keep in mind that there are now no prior- approval supplement fees and, instead, there are now program fees.

When you look at the difference in fees it is hard to see how the new fee structure looks like it is really taking the pressure off anything, but it does shift some of the costs to larger firms and ultimately the facility fees and establishment fees which would otherwise be much higher!  In addition the ANDA fees would have also been sky high  with the revised total GDUFA II bill of $493.6 million. We will have to see how the industry reacts to this new structure.

FDA is estimating that approximately 938 to 948 new original ANDAs will be submitted and incur filing fees in FY 2018. Please see the link cited above for a full explanation of how the FDA determines all of the different fees and options for paying those fees.  The fees will more accurately reflect the FDA’s actual workload, as it was about one-third higher than expected during GDUFA I.  I guess we can be thankful that the President’s request to double the fees was not considered in the new legislation!