I Just Don’t Get it. No Wonder Why Industry Scratches Its Head!


We have reported on discrepancies in the reporting of the number of approvals on the FDA Monthly Approvals Report (here and here) in various posts (here and here) .  In addition, we have reported on the problems that FDA staff has had with the implementation of their new IT platform (here, here, and here) .  But still, today and over the last three months, the numbers of approvals reported by the Office of Generic Drugs (OGD) cannot be reconciled with the numbers reported on the FDA Monthly Approval Reports (here).

One would think that the new FDA IT platform would make it easy to track and report approvals, but just look at the discrepancies found for just approvals in the last three months in the table below:

Month 2015 Actual reported by OGD Approvals found on FDA site
September 58 54
October 51 50
November 61 56


It is no wonder that the generic drug industry is in a quandary about transparency and accuracy of reporting.  While we believe in the numbers that OGD provides on its Report of Generic Drug Activity, the discrepancy lends itself to mistrust of the IT platform in general, and causes the industry to question the numbers reported.  I have been personally asked to explain why some of the numbers provided in my posts differ from others reported in OGD presentation or found on the web.  I explained that I believe the systems are not yet capturing all of the data in a consistent manner.  As a matter of fact, even OGD’s slides that report some statistical data on approvals, receipts, etc., have a disclaimer that the data is being scrubbed for formal reporting purposes (see slides here)  (And that statement begs the question- what does this mean to Congress or to the generic drug industry?).  Anyway, we do the best we can with what we are able to ascertain!

I will let you know when the numbers begin to sync with the various reports.