Holy Moly! Buckle Up! The Blip Turns Out to Be Mount Everest with about 600 ANDAs in June so Far!

The Office of Generic Drugs (OGD) confirmed today that the rush to get ANDA applications into the Agency before the new stability requirements go into effect on June 20, 2014 flew past all estimates and landed at just under 600 (the unofficial count is 598).  OGD was shocked by the number of submissions with many there predicting a figure around 350.  I lost a dinner bet with Kurt Karst who predicted 300 and I picked the under of around 250.  Boy, did I lose! 

The rush was certainly on with a total of about 370 ANDAs submitted in the last 4 business days leading up to the June 20 deadline.  One positive comment from OGD was at least we know the Electronic Gateway can handle the volume!  But, that appears to be the only good news for OGD and the Agency as that means that, as of today and with 10 days left in June and with 3 more months until the fiscal year ends, OGD has already received 1400 ANDAs in FY 2014.  OGD expects numbers to be light over the next three months but they still could easily reach 1500 by the end of the Fiscal Year. Because this is a family-friendly blog, I cannot print my true reaction to that number.

This avalanche of ANDAs means trouble for OGD and CDER relative to the entire GDUFA program- even though applications in cohort years 1 and 2 do not have metrics associated with them, they still have to be reviewed.  Maybe there needs to be a new cohort year 1 and 2 backlog fee to address this staggering number of submissions (over 2500) so far under the first two years of GDUFA.

It will be interesting to follow the Refuse-to-Receive (RTR) statistics over the next few months as I am certain that many of this group of 600 ANDA were likely rushed into the Agency.  This also raised another interesting question that has been previously pondered – if an ANDA is submitted before the June 20, 2014 date but receives a RTR letter, will the ANDA need to meet the new 3 batch/6 month stability data requirements on resubmission?  That question was posed to OGD this morning and we will report on the outcome when we hear the final OGD interpretation/decision.

With 600 more ANDAs in the queue for completeness and acceptability review, it may be 6-8 months or more before a firm learns if its ANDA has even been received!  The Q&A Stability Guidance addresses amendments to ANDAs submitted after June 20 (for instance, a new strength submitted in an ANDA) but does not define if submission means just that, the date the ANDA was originally submitted, or whether an ANDA that receives an RTR letter is considered submitted.  Let’s hope the latter applies for both OGD and industry’s sake, because the battles over this interpretation of the answer to D.Q1 in the Guidance  (reproduced below) could mean substantial delays in amending an RTR-ed ANDA if two additional batches and 6 months stability data must be generated.

All amendments submitted to pending ANDAs after the effective date of the final FDA stability guidance will be held to the standards in place concerning stability data at the time of the original ANDA submission, unless there is a concern with the submitted stability data.

With no mention of RTR in the question or answer, this is certainly something that needs to be clarified so industry does not fret until they get the word on ANDA acceptability.

So as we move forward, the climb gets tougher, the uphill trek towards ANDA approval gets steeper and clearly longer.   What can we expect for submissions beginning in October, the start of FY 2015, as we understand many firms are delaying submissions until October 1 when the first GDUFA metrics for ANDA review kick in?  Will that be another unexpectedly high submission month? Then there is the usual end of calendar year December rush – what will that look like?  Seems like there are more and more submission rush months being seen every year!  How will the extraordinarily large number of ANDAs submitted over these 2 years of GDUFA impact ANDA and supplemental submission fees? Will the Agency take into account this unusual bolus of 600 ANDAs when calculating the ANDA fee?  GDUFA has certainly generated many more questions than answers so far in its two year existence.