January 2016 Approvals Update and Receipts

The number of approvals reported yesterday was revised upwards by 1 to 43, according to the Office of Generic Drugs (OGD).

OGD also reported the number of new original ANDA receipts as 35.  This number consists of 22 new original submissions and 13 responses to Refuse-to-Receive letters.  Some may wonder why receipt numbers look different over the GDUFA years depending on when the number is reported.  The reason appears to be that, from time to time, OGD has changed receipt reporting requirements.  At one juncture, OGD was reporting pure receipts (how many applications came in the door during a given month).  That was when OGD had a large backlog of ANDAs in the initial completeness and acceptability review queue.  Now that the “filing” or “receipt” backlog has been eliminated, OGD is reporting receipts only when they acknowledge the application for receipt.  This makes sense because, if an ANDA receives an RTR letter, it is not assigned a GDUFA goal date.  However, this raises an interesting question as to when is a submission reported as being received, if the RTR decision is overturned a month or two later. Does OGD then go back and adjust the monthly numbers?  We have not seen that happen, so we don’t know how they are counting those instances.  This could further explain why you will see different receipt numbers at different times and why OGD acknowledges in a note at the bottom of its activity reports that states:  “NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.  These numbers are not intended for Congressional reporting purposes.”

Oh, by the way, the on-line Activities Report of the Generic Drug Program was updated overnight to include correct totals for the three months and additional numbers (for instance supplements) that I pointed out were missing in yesterday’s post here.

Looks like OGD does pay attention to this blog!