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:
|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
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!