Woman on the phone looking confused at a broken computer

Don’t Panic – ANDA Approvals Continue To Roll Along – But A Glitch Might Not Make Them Immediately Visible

I have blogged about a problem with the discrepancy in the official August approval numbers that the FDA issues in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Report) (here) and those appearing on the FDA daily approval list (here) and the FDA All Approvals list (here).  The latter two listings showed only 59 approval actions in August, but the official approval actions displayed in the (Report) listed 66 approvals.  A difference of seven that have yet (as of 9/19/19) to show up on the Daily and All Approvals listings.

Early in GDUFA, there was a problem reconciling the FDA official counts on its Report and the two lists as the totals did not match but that was resolved after a computer migration issue was resolved.  For some reason, the same or at least a similar issue appears to be happening now.  A review of the September full approval actions on the Daily and All Approval list document only 6 September approvals as of 9/18/19.  This sent me into a tizzy as, historically, OGD is well on its way to over half of its average monthly approval actions by mid-way through the month.

A quick call to OGD and it was obvious that there was a problem as there are many more approval actions (over 5 times what is publicly reported in the Daily and All Approvals report) already logged for September.  Thus, there must be another bug in those pesky FDA computers that are somehow affecting proper migration into the two publicly available resource lists.  Hopefully, the Agency will resolve the issue shortly as clearly following the approval actions throughout the month is of great importance to the industry and the public.  I know that this resolution will keep my heartburn in check.