December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.
The prediction of Dr. Uhl and yours truly – that the OGD machine built on the back of GDUFA at quite a cost, not only from a dollar standpoint but also from a time and effort in hiring and training – is beginning to spit out the desired result – approvals. OGD to date has meet all of its GDUFA goals and has implemented many non-GDUFA requested remedies (e.g., the Target Action Date) to improve review and approval times, and to increase transparency between OGD and the industry.
While we don’t have too much data to deal with so far for FY 2016, if we project the October-December approvals (now at 190) on a straight line, OGD could hit 760 approvals this fiscal year, well above the 440 average number of ANDAs each FY since GDUFA was implemented (2013-2015).
That’s the good news! For months, actually since June of 2014, everyone has wondered why there was such a slowdown in ANDA submissions. Maybe it has taken industry this long to refill its pipeline with the newly required amount of stability data for submission, or maybe it has just strained the manufacturing schedule to get the 3 exhibit batches squeezed into manufacturing and production schedules, or whatever the reason, December saw the first time OGD hit even close to triple digit new original ANDA submissions with a whopping 175 receipts. This could spell trouble for the clear sailing in review activities that the slowdown has given OGD since July of 2014. If we straight line original ANDAs received for the full 2016 fiscal year, we may be looking at another 1000+ submission year. Remember that GDUFA staffing was premised on receiving 700-750 ANDAs per year.
Anyway, let’s take the good news and hope that the OGD review machine can handle anything thrown at it. I know that industry is ready (albeit somewhat surprised by some of the long information requests and complete response letters) to look for the bright spot in the GDUFA skyline.
