The new statistical report of the Activities of the Generic Drug Program (FY 2018) Monthly Performance (here) was posted on December 4, 2017. There are many new statistics being captured and to tell the truth I am not sure exactly what they all mean but I think I’ve got it straight. Please take a look at the above report and if you disagree with my reading on any of these metrics please give me a shout out.
There were 10 Refuse-to-Receive (RTR) actions reported in October and quite interesting now OGD reports on RTR actions for standard and priority applications. All 10 of the October RTR actions were reported for standard review ANDAs. OGD is now also reporting on RTR actions for certain supplements and they report 1 such action for the October period.
While OGD has been reporting the number of ANDA it receives each month for ever, they now are reporting on the number of Acknowledgment letters issued (which is obviously not the same as the number of ANDA received). FDA is also breaking down the number of ANDA withdrawals it processes each month and is reporting separately on withdrawals of approved ANDAs as well as pending ANDAs. Interestingly, this breakdown provides some additional transparency relative to firms taking action to abandon ANDAs submitted but not yet approved. While you won’t ever know what they were, it is a new metric of what I believe to be of considerable interest.
OGD is also providing additional information on its approval actions by providing the number of first cycle approvals for both full approvals and tentative approvals. Of the 87 full approvals OGD notes that 26 represented first cycle approvals and 2 of the 14 tentative approvals were first cycle Tentative approvals. Given the fact that the most recent rates of first cycle approvals reported by OGD were in the neighborhood of 11.5-14%, this 29.9% figure is a staggering increase and leaves me somewhat puzzled but impressed. Despite my somewhat questioning nature, in taking another look at the ANDA numbers of applications approved in October, it does appear that this is a correct accounting. The number is a bit difficult for industry to track and verify because the approval letters of the ANDAs are not routinely available on line, and that is the only way to determine when the ANDA was submitted.
OGD is also now reporting on Major and Minor Amendments as well as unsolicited amendments submitted during each month. One other interesting piece of data in the October report, is that OGD received 83 prior approval supplements (PAS), a record high and with the exception of August 2016, when OGD received 71 PASs, is almost double any other month. This is likely because there are no more PAS GDUFA fees for submitting a PAS. We will need to watch that metric closely over the next few months.
Looks like OGD has geared up over the 5 years of GDUFA I and the opening of GDUFA II may be showing the growth in efficiency and productivity of OGD. Let’s hope the trend continues.