In a previous blog, we postulated that the start of FY 2017 looked like the ANDA submission rate could be off to the races. We also speculated that December original new submissions might reflect firms’ end of year push to get applications into the Agency. We did not think we would see a submission number as high as the 235 reported by OGD for December 2016. That is the second highest number of ANDAs submitted in a single month previously, since the inception of GDUFA (635 ANDA submitted in June 2014 – in anticipation of the change in stability requirements and 225 in December 2013).
Now not to sound alarm bells too loud, but if the current three-month average holds for the year, OGD could receive a record breaking 1695 ANDAs in the fifth year of GDUFA. Hopefully, the influx of submissions just represents a blip, but with 424 ANDAs already submitted in the first three months of FY 2017 and with the FDA’s budgeting for GDUFA I to accommodate 700-750 ANDAs a year, there has got to certainly be some concern at OGD. However, the input could certainly be set to overwhelm the output at this rate. OGD issued 56 approvals in December and sent out 19 Tentative Approval Letters along with 145 Complete Response Letters. Those numbers represent the average output we have seen over the first three months of FY 2017.
The 1473 ANDAs submitted in FY 2014 were a scare to the system (at least on the industry side and I assume a gulp or two may have been heard on the OGD side), now with even a potential to beat that record number of submissions, will GDUFA II come in time to bolster OGD resources to address these larger submission rates? Will we see over 100 ANDAs submitted from industry every month? Can OGD absorb the additional workload and continue to meet GDUFA goal dates? Remember, the GDUFA goals are fixed and don’t move on a sliding scale based on submission workload. All we can do is continue to monitor OGD’s progress and hope the robust review system can handle the burgeoning influx of ANDAs.
Good luck OGD, we are all rooting for you!