Nine Months into FY 2014 and the Numbers Stagger the Mind

With 9 months gone in FY 2014 and the June Generic Drug Activity Report just released, things don’t look so good!  We reported that almost 600 ANDAs were received in the first 19 days of June (an attempt to beat the new stability requirements that took effect on January 20) (see post here) , the total number of original ANDA submissions for June was 635 and, so far, for the first 9 months of 2014, OGD has received 1440 ANDAs (the total for all of FY 2013 was 968).  The June ANDA submissions not only beat any previous one-month total ever, but shattered the previous record by almost 275%.  The big problem when looking at the numbers in the Activity Report is not only seen in the number of ANDAs submitted, but also in the disturbing trend in the numbers in general. 

The readers of this blog know that I have complained about the OGD’s lack of transparency relative to how it fails to report the backlog of ANDA applications and supplements pending before the Agency.  While OGD has said that the old statistical report (last published in August 2013) no longer properly reflects the data that GDUFA requires to be captured, I say the backlog is the backlog, and consists of all ANDAs pending along with all supplements (CMC and labeling) that are pending before OGD and should be reported for each category of submission like in past statistical reports.  That is the true backlog – and represents all the application work OGD must slog through to catch up and eliminate the backlog (whether that is backlog applications defined under GDUFA as those arriving at the Agency before October 1, 2012, those that have come in during cohort year 1 and 2 or those that come in after the metrics begin on October 1, 2014).  I so wish FDA would publish those figures as that, in my opinion, would give the industry a more accurate picture of how OGD is progressing or how much further they are falling behind.

Anyway, to my simple mind, if we just look at what comes in to OGD versus what goes out of OGD, we will see the backlog grow or diminish.  So I looked at the numbers reported so far in FY 2014 (9 months of data) only for ANDAs (originals and amendments) to see what I could see.

I defined what comes in as the number of ANDAs and amendments to ANDAs (granted this is not a perfect definition because multiple amendments could come in to the same application).  For what goes out, I selected Approvals, Tentative Approvals, Withdrawn applications, Refuse-to-Receive (RTR) actions and Complete Response Letters (CRL). My rationale was that, even though some of these actions may not represent true actions on the backlog, as some withdrawals are for older, already approved applications, rather than withdrawal of only pending ANDAs, and ignored the fact that some of the actions (e.g., RTR actions) turn around quickly and come back into the backlog, so I figure that the slop in the numbers on the in v. out calculations is likely a wash).  With that background, the Activities Report has the total for what came in to OGD thus far in FY 2014 at 2768 and the total for what has gone out of OGD (came off the OGD books) at 1625 for the same 9 month period.  Thus, it would seem to me that the total backlog (work before OGD) could have increased by about a factor of 1150 pieces of work.  This does not bode well for forward progress.

Now, perhaps my concern can be tempered by the fact that OGD is eating up resources training new staff so they can become efficient productive members of the review teams, or by the fact that this enormous number of submissions is only a flash in the pan never to be duplicated again, or that OGD staff are spending a fair amount of time publishing GDUFA guidance or resolving complex scientific issues and once all of these activities are completed the rate of original approvals, CRLs and supplements will soar and the “backlog” of both will decrease dramatically.  But, if the numbers of submissions continue to roll in at the current pace or even at the increased rate over what FDA expected during the GDUFA negotiations, OGD and industry will both be looking for buckets to bail out the ship.

I hate being negative, but I also believe in being realistic.  We have not yet seen the turning of the corner and I don’t believe we even know where the corner is.  All that I know is what the numbers tell me.  I almost hope I am looking at them in the wrong way, but something inside me says I am more right than wrong.  Remember, metrics kick in in about 2.5 months for cohort year 3 and that worries me even further!  But don’t get me wrong- I know that OGD is peddling as hard and as fast as they can, I know that they are working long hours, I know that they are doing much more than only review activities as OGD is a complex office with lots of other work besides application review.  So kudos for keeping your heads above water, OGD, but I sense the river is continuing to rise.  The question is then, when will it finally crest?