Well, the new statistics started rolling off the assembly line last night and appear in a new report that combines the generics monthly statistical report and the Quarterly Report.  The new name of the report, which we discussed in a blog post (here), is the Generic Drugs Program Monthly and Quarterly Activities Report.  We will talk a bit about the differences in the report format and the metrics reported but, first, let’s summarize the long-awaited, first official statistics as reported for October 2022, the first month of FY 2023.

We reported the unofficial approval actions numbers on November 4th (here), and now the official totals for approvals and tentative-approval actions are available.  We reported fifty-eight full-approval actions (and hit that one on the head!); we also reported tentative-approval actions of eleven, but there were actually thirteen, when the final tally was provided, for a total of seventy-one approval actions for October 2023.  Of the fifty-eight full-approval actions, one was a first-time generic approval and fourteen (or 24%) were first-cycle approvals.  That’s one of the highest percentages we’ve seen in a while for first-time approvals.  We still await the official November stats from the OGD.

Now, we will walk you through some of the changes to the metrics reported and provide the numbers associated with these metrics (at least for October).

First off, the refuse-to-approval letters dropped down the list of metrics in the new monthly report format, and there was only one issued for a standard application in October.  We note that the ordering of additional metrics has changed, with approval actions being listed first (which highlights the importance of this front-facing metric to the generic drug industry).  Under approvals, the OGD is now also reporting Imminent Actions (IA), which refers to the OGD extending the GDUFA goal dates in order to take applications to final approval.  There were seven of these IA actions taken in October for full approvals, and one reported for a tentative approval.

The OGD continues to report complete response letters (CRLs) and, for the first month of the FY, it issued 148, which is slightly below FY 2022’s monthly average of about 157.  The OGD acknowledged only twenty-six new ANDAs, which is by far the lowest number of newly acknowledged ANDAs since the OGD began reporting that metric in FY 2018.  The OGD is now reporting approved prior approval supplements (PAS) in the new report, and the first month showed 117 approved.

Information requests issued totaled 297 (towards the low end of what we have seen in the last FY), and discipline review letters totaled 224, which is about standard.  Two new metrics being reported are the numbers of Reclassification of a Facility-Based Major CRLs granted and denied.  For October, both were zero.  However, the OGD is now also reporting the number of Requests for Reclassification of a Facility-Based Major CRL amendments, and there were thirteen of those.

The OGD has begun to report monthly the number of pending ANDAs awaiting FDA action (1,584) and the number of ANDAs awaiting applicant action (2,177), and further break down those pending applicant action into those awaiting responses for tentative approval (469) and those awaiting responses to CRLs (1,708).  These two metrics previously appeared only in the quarterly reports.  There were also seven Pre-Submission Facility Correspondences submitted in October.

The OGD received only thirty-four new ANDAs in October, which is the lowest number of ANDAs received since last October when the OGD received only twenty-four.  Seems like the pipeline of ANDAs for submission might dry up after the end-of-the-FY rush to get ANDA applications into the OGD before the GDUFA fees change.

Total supplements submitted were 693, broken down into 584 changes being effected (CBE) and 109 prior approval supplements (PAS).  Controlled correspondences were at 267, now broken down into Level I (235) and Level II (thirty-two).  In addition, there are a number of metrics for tracking new meeting types that grew out of the GDUFA III reauthorization and appear in the GDUFA III commitment letter, such as product development meetings, pre-submission meetings, Product Specific Guidance (PSG) teleconferences, pre-submission PSG meetings, mid-cycle review meetings, enhanced mid-cycle review meetings, post-CRL clarification teleconferences, and post-CRL scientific meetings.  None were reported in October since this is just the beginning of the FY.

Because this is the beginning of the FY, there are no metrics for approval times by quarter; they will appear in this combined report format after the close of each quarter.  The report also contains definitions of the abbreviations found in the report as well as annotations regarding the origin and calculation of the metrics where applicable.

Now we understand the delay in getting the first official report of the FY published as the detail, formatting, and collection of this data required considerable work on behalf of the OGD.  Hopefully, now that the new report has taken its initial flight, it will be smooth sailing from here on out.