KA-BOOM!! ANDA Submissions Explode in December – The GDUFA Goal Letter May Expose the OGD Donut Hole

Well, just a few days ago I posted a blog on OGD activity for the first two months of FY 2014.  Today, the December numbers came out and holy cow!  While December is notoriously a month of heavy submissions due primarily to the end of year rush, this December beat all records at an astonishing 225 ANDAs.  That represents a little over 23% of all of the ANDAs that were submitted in FY 2013 and beats the previous single-month record of 210 in December 2011 (and that month was unusual because it represented the deadline for the submission of ANDAs for Positron Electron Tomography [PET] products.  Of that 210 total, about 60 were for PET products).  Also during the month of December, OGD approved 30 ANDAs and tentatively approved 12 others.  So OGD managed to clear 42 ANDAs off its books for good, but received 225 ANDA or a monthly surplus(if you will) of 183 applications that are added to the “backlog” of applications pending before OGD.

So far in the first quarter of FY 2014, OGD approved or tentatively approved a total of 116 applications, but received a total of 324 ANDAs.  If the rate of monthly submissions and approvals remains the same over FY 2014, that would mean OGD would receive about 1300 ANDAs and approve/tentatively approve about 464 or a surplus of about 850 ANDAs.  Are you seeing a continuing trend developing?

That leads us to the OGD “donut hole”, which might be somewhat analogous to the Medicare donut hole.  It is becoming obvious that some of the assumptions used in the negotiations of the GDUFA fees and goals back in early to mid-2010 might have been understated.  However, the problem for industry is that, if you read the GDUFA Goal Letter carefully, nowhere is there a goal for approval actions.  I know, it is difficult (if not impossible) to set a goal for approval because of the differences in application quality and the dynamic nature of FDA requirements, as well as some unique challenges that certain complex products may pose.  However, the fact is that application goals all relate to the issuance of complete response letters (CRLs).  Thus, OGD can continue to meet all of its stated and negotiated goals by the issuance of on time CRLs.  In previous posts, I have noted that the only way to really get rid of the backlog (not the GDUFA backlog of pre-FY2012 applications, but rather all of the ANDAs that are pending before the FDA or those that have already received CRLs and will come back into OGD’s court when the sponsor submits their complete response) is to reduce the number of cycles that an ANDA must go through to final approval.  The question that may need to be addressed(perhaps in GDUFA II) is whether the “GDUFA Goals” as stated may have a tendency to increase the number of review cycles so OGD can meet its currently agreed upon goals.  I certainly hope not and I am sure that OGD management also hopes not as well.  However, if the number of ANDAs and supplements continues to grow from the original submission pool and the applications and supplements in the backlog (all work before OGD) continues to cycle through the review process with CRL after CRL, is that really what the industry really thought they were buying with generic drug user fees?   This issue is what I lovingly term the OGD donut hole.  You can nibble around the edges, but the hole still remains- as do the applications.  We have not seen any figures from OGD on the median approval times.  Nor have we seen any backlog figures for ANDAs or supplemental applications.  When we last saw those numbers (August 2013), the backlog of ANDAs was 2780 with another 560 awaiting applicant action and the number of supplements pending OGD was 5601.

The efforts of the New Drug Review Divisions work in getting the backlog down when PDUFA was first implemented relied on an industry learning curve (really needed by the generic industry), but also on close cooperation between FDA and industry.  Early communications between the New Drugs groups and sponsors that has over the years boosted first cycle approvals for NDAs to their highest levels.  Certainly, this is a much more challenging proposition for OGD when dealing, as it is, with an overwhelming backlog and original ANDA submission of about 1000+ a year.  But maybe taking a play from the PDUFA playbook and applying some of the early communication techniques and employing closer contact with ANDA sponsors is a way to significantly boost first-cycle approvals in OGD that will ultimately relieve the “backlog”.  Remember, one of the purposes of Hatch-Waxman was to get high quality generic product to market and into the hand of consumers to lower associated healthcare costs.  This implies, of course, faster access to generic drugs.

We in industry need to watch this issue closely and not be lulled into a false sense of security when OGD says it met all of its GDUFA Goals, because the ultimate goal for industry is reducing approval time and getting their quality products to market.