May Numbers are in! OGD Keeps the Approvals Up – Somewhat

The Office of Generic Drugs (OGD) had another good (OK) month in terms of approval actions with the approval of 44 ANDAs and tentative approval of 13 for a total of 57 approval actions for the month.  The number of receipts totaled 40 – obviously just under the number of full approvals for the month.

While the numbers for April and May are comparable, the number of receipts (we are still not certain why the receipt numbers are so much lower so far this FY) still typically outpace approvals.  As such, the backlog will continue to grow, albeit at a much slower pace.  One FDA official noted that we need to be getting out 70-80 or more full approvals per month to really close in on eliminating the backlog.  The average numbers of approvals and receipts per month over the last 9 years shows the disparity between approvals and receipts, which has contributed to the backlog of almost 4000 ANDAs. (see Table 1 below.)

Table 1 – Average Monthly Approvals and Receipts Calendar Years 2006 through 2014

I am still surprised by the discrepancy of the FDA Monthly Approvals report vs. the actual number of approvals cited by OGD.  Today, the FDA site reported 32 full approvals, although FDA said there were 44 full approval actions.  I hope that FDA gets their IT gurus focused on the system that reports the numbers to the general public to get out timely, accurate, and up-to-date figures, as that would be one measure of transparency that industry would truly like to see.  Industry also finds it frustrating that the Activities Report for the Generic Drug Program has not yet been updated with the April data.  Timely positing of this data would help industry better understand the workload issues OGD faces, and improve transparency of the program’s activity.