GDUFA First Quarter FY 2015 in the Books – Not Quite What Was Expected!

First, I would like to welcome back all of our readers from the holiday and hope you all have a happy, healthy and prosperous New Year.  Now, with the first quarter of GDUFA 2015 and metrics behind us, we are seeing what FY 2015 may have in store for us, and importantly, we have observed that (at least right now) you cannot always believe all of the numbers you see.

As previously reported, the Generic Drugs Activity report was not available for months one and two of FY 2015 because of some problems associated with the new IT platform adopted by the FDA.  Those kinks are apparently still being worked out.  We inquired to the Office of Generic Drugs (OGD) about the lack of availability of the numbers and they responded in kind by posting a condensed version of the statistics of major interest to the industry (here).  As is readily apparent, when compared with previous versions of the reports (here and here), many of the specific details of this condensed version of the OGD Activity report of interest to industry are not yet available.  We are, however, very appreciative of OGD’s efforts to make some of the productivity numbers that are most important to industry available.

The only numbers available for the first full quarter of FY 2015 are for approvals and receipts of original applications, which are 104 and 112, respectively (compared to 90 and 324 for the same period in FY 2014).  So, OGD approved about 10% more ANDAs in this first quarter and received only about a third as many ANDAs over the same period as it did last year.  If the numbers continue at this pace over the full FY, we can expect OGD to approve about 416 ANDAs this year (compared to 409 in FY 2014) and receive in the neighborhood of about 450 ANDAs (compared to the record 1473 received in FY 2014).  In December 2013, OGD received 225 original ANDAs but, this December, a historically application-rich month as firms attempt to meet their year-end goals, OGD received only about 40 originals.

Data for Complete Response Letters (CRL) is only available right now for the months of October and November FY 2015 and they total 119 for that two month period, compared with 239 for the corresponding two-month period of FY 2014.  Another interesting observation is that for the two-month period, OGD issued only 10 Refuse-to-Receive (RTR) letters compared with 40 for the first two months of FY 2014.  With the rush to get all of the 625 ANDA submissions in before June 20th and the new stability requirements, one might have thought that there might have been more RTR letters as OGD tightened the requirements for receipt of original ANDAs.  Not so, at least not yet anyway!

So is this good news?  We believe that the slowdown in submissions is certainly a good thing for OGD and what we see is perhaps a trend for OGD to drive ANDAs to the approval stage, rather than issuance of CRLs is good for industry; however, there are still a lot of numbers that are not yet available, and perhaps, we are not far enough along in FY 2015 to draw any firm conclusions at this point in time.

One thing we can say for certain is that you can’t always believe what you see in some of the FDA databases quite yet.  For instance, more than midway through December, the number of ANDA approvals listed in FDA’s public Monthly Approvals database for November stood at 14, but according to OGD, in their internal approvals report OGD showed that they approved 28 ANDAs that month.  Shortly after my inquiry, the database was updated to indicate the approval of 26 ANDAs for the month and after checking today, it still only lists 26 approvals.

OGD is working hard to move the freight and now also to assure that the integration of the new IT platform performs properly, especially when reporting out on its activity.  Hopefully, the various reports will be appropriately reconciled soon and we again will have a better window into both OGD activity and productivity.