Lots! Here we are in mid-January, almost one-third of the way through the first GDUFA metric year and year three into the GDUFA program itself. As we have reported previously (here and here), CDER is having trouble with its new IT platform and, thus, reporting its statistics to the industry has been difficult at best and, at most, very confusing for anyone outside of FDA. For instance, here we are on January 20 and the FDA Monthly Approvals report (here) shows 11 ANDA approvals thus far. The first 9 approvals were for Valsartan Tablets (valsartan day) (all of the products moved to final approval after previously receiving tentative approval all of which occurred on January 5, 2015) and two additional products were also approved, one January 7 and the other on the 8th, but nothing more reported beyond that date on that site. However, today on “What’s New At FDA”, the Agency reported generic first-time approvals and listed Ritonavir Tablets, which was approved on January 15, 2015. So, we know that at least these two databases are not coordinated or at least are not synced to report together. Previously, ANDA approvals showed up on the FDA Monthly Approvals Report the day after approval and were usually reported on What’s New on the CDER web page. We find that neither of those things are happening now. With that said, it is difficult (if not impossible) to track the approval traffic with a sense of accuracy relative to the numbers being reported on the sites available to the public.
In addition, it is more than halfway through January 2015 and the December 2014 statistical report (albeit abbreviated – again, because of the IT platform problems) has not yet been updated. The Activities Report of the Generic Drug Program for FY 2015 (here) reports a limited number of activities, including approvals and tentative approvals, withdrawals, Complete Response Letters, DMF reviews, and original ANDA receipts for the month. Many of the other statistics available in previous reports have not been updated (blank items in the 2015 report). Hopefully, FDA has their IT staff working diligently on getting the different databases to communicate and to be able to generate the reports necessary for the transparency the industry needs.
This is just another of the priorities that defines time – Time is what keeps one darn thing after another from becoming every damn thing at once! Let’s hope for the sake of transparency and for the industry this issue is one that the Agency can resolve quickly.