Six months into Fiscal Year 2014 and some staggering submission numbers should send a chill up the old OGD spine.  So far, this FY OGD has received 597 new original ANDAs based on numbers released on April 11, 2014.  That number reflects activity through the end of March 2014.  On the other hand, OGD has approved 392 ANDAs in the first 6 months of this FY.  So let’s look at the numbers a bit more closely.

With a couple of important dates coming up, we expect to see the number of ANDA submissions skyrocket.  First, expect that the number of ANDA submissions in May and first half of June to be huge.  Why?  Because on June 20, 2014 the new stability requirements for 3 exhibit batches and 6 months of room temperature and accelerated at the time of filing will become reality.  Thus, firms will be rushing in ANDAs trying to beat the clock.  Secondly, on October 1, 2014, the new FY 2015 GDUFA fees will go into effect.  So we expect to see the September ANDA submissions to be brisk as they will still fall under the FY 2014 GDUFA fee schedule.

The average monthly submission rate for original ANDA in FY 2014 is 99.5 and if that rate continues, OGD can expect to receive 1194 ANDAs this fiscal year, which would be about 100 more than ever received in a given fiscal year.  The monthly average approval rate of just over 32, if that pace continues, would yield about 392 ANDAs approved this fiscal year.  That would mean the difference between submissions and approvals would be about 802, which is just 11 ANDAs short of the total of ANDAs submitted in FY 2010 (the base year for the GDUFA negotiations).

Clearly, the numbers upon which the GDUFA workload and productivity estimates were based appear to be about 20% lower than the reality of the current day filings belie.  Woe is OGD because they really can’t do anything to increase staffing as GDUFA is set for a 5-year period.

On the positive side of the ledger, OGD has issued 694 complete response letters in the first 6 month of FY 2014 for an average of 116 per month.  But with ANDA submission rates at about 100 and with 2800 ANDAs or more in the total backlog, something has to give if OGD is ever going to be able to dig out of the hole they find themselves in.

We certainly wish OGD good luck and hope they can figure out a way to make a lot of first cycle approvals for both original ANDAs and supplements.  As Cook has said, “the CRL is the gift that keeps on giving” meaning that OGD will undoubtedly receive an amendment in response to the CRL, and thus, will need to deal with the application again and again.  Or put another way – the never ending story!