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Silver Spring – We Have a Problem! August Approval Numbers Don’t Add Up!

OGD published their official approval actions for August and the Agency posted 66 full approval actions and 13 tentative approval actions in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here).  However, the FDA All Approvals list (here) for August lists 59 full approval actions and the correct number of tentative approvals (13).  What happened to the 7 extra approval actions the FDA reported on its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance for August? They are nowhere to be found!  We know of at least one approval that does not show up on the All Approvals list because it was for one of our clients.

Quite curiously, when we report the unofficial numbers a day or 2 after the month ends, we usually wind up a few short, but here we are on September 12 and the August total is still off by 7?  Also, of concern is that, for the last 3 business days of August, there were no reported approval actions and only 1 tentative approval action on the Daily approvals list and the All Approvals list.  Following along with the first 7 business days of September, there are 3 days with no approvals and only 5 reported during that 7-business day period (September 3-11, 2019).  This strikes us as quite odd, as (historically), even in low approval months, you don’t see that many days with no approvals.  Along with the discrepancy between the OGD Activities Report and the number of ANDAs on the All Approvals list, this leads us to suspect something is amiss.

Is there a problem with the FDA computer system underlying this reporting system? Are the approval actions not being recorded in the database for some reason?  We just don’t know.  I have raised this issue with someone at OGD, whether I will get any feedback is another story.

Ok, enough of Where’s Waldo, we can report that OGD also updated its Activities Report for August to indicate it issued 211 complete response letters and reported receiving new 44 ANDAs (which is well below the average of 69 ANDAs received in August since GDUFA reporting began*). We will refrain from providing projected averages for approvals and receipt until the FY is over at the end of September and hopefully, we will find out what happened to the 7 August approvals and whether  the September numbers reported in the All Approvals list are accurate thus far.

(* We did not count 2014 August receipts as this was just 2 months after the huge bolus of 635 ANDAs were submitted in June 2014 before the new stability requirements went into effect on July 1, 2014.  For the sake of full transparency, only 4 ANDAs were submitted in July and August of that year.)