Here Comes the Flood – Amendments are the Next Mountain to Climb for OGD

The February 2015 Generic Drugs Activity Report looks much like the previous month’s report except for the number of amendments seen flying into the Office of Generic Drugs.

GDUFA YEAR/
Amendments
Oct-14 Nov-14 Dec-14 Jan-15 Feb-15
Originals (Pre FY15) Administrative 119 228  388  339  429
Originals (Pre FY15) Solicited (CR, ECD/IR) 86 80  178  320  582
Originals (Pre FY15) Unsolicited 398 229  108  118  84

 

The above chart shows amendments coming in for pre-FY 2015 ANDAs, and, as you can see, the numbers are going off the charts.  A total of about 1100 amendments for pre-2015 applications came in this month.  These are presumed to be backlog ANDAs and cohort year one and two amendments, but the definition is not entirely clear.  The bottom line is that industry is pushing in responses to previously submitted applications at a faster pace.  The other thing that is not evident is how many of the amendments may be submitted to the same application.  Nonetheless, the number of ANDAs coming back onto the OGD clock must be going up, which means the ANDA backlog (as I define it, as work that OGD has on its plate) must be reaching the 4000+ level.

There also still seems to be a discrepancy in the numbers of ANDAs approved and tentatively approved as reported in the Generic Drugs Activity Report for 2015 and the FDA monthly approvals posted.  For instance, approvals and tentative approvals from the February Generic Drugs Activity Report are reported as 27 and 13, respectively, but the FDA Monthly Approval Report list approvals and tentative approvals as 21 and 10.  Looks like the disconnect between these reports is still a problem.

The chart below shows that cohort year 3 applications are already receiving an increase number of amendments and the Easily Correctible Deficiency and Information Requests are starting to show up for the FY 2015 original submissions.  This shows that OGD is attacking the cohort year three applications, and responses are beginning to flow in.

GDUFA YEAR/
Amendments
Oct-14 Nov-14 Dec-14 Jan-15 Feb-15
Originals (FY15) Administrative 1 21  20  30  21
Originals (FY15) Tier 1 0 0  0  0  0
Originals (FY15) Tier 2 0 0  0  0  0
Originals (FY15) Tier 3  0 0  0  0  0
Originals (FY15) ECD/IR 0 7  4  43  37

 

The question is how does the Agency handle the large influx of the pre-FY 2015 amendments, as these applications actually have no GDUFA goal dates?  So, while OGD may get a break with the lower number of original ANDA submissions so far this year, the number of amendments pouring in will easily eat up any excess review resources that may have been realized through the dip in the original ANDAs submissions thus far in FY 2015.