New End of FY 2023 Posting by OGD Takes Some Time to Figure Out

The FDA published the Generic Drugs Program 2023 Fiscal Year Web Posting (here) on December 28, 2023.  This document reflects the FDA’s performance for meeting GDUFA goal dates for FY 2023 submissions.  The document meets the required reporting of certain performance metrics as outlined in the GDUFA III commitment letter.

Bravo to the OGD for getting the report out on time but, for goodness’ sake, if a bit more of a narrative had accompanied the report, it might have made figuring out what the numbers represent a little easier.  While the report can be viewed at the above link, if you have any difficulty interpreting what the numbers reported mean, don’t feel bad!  Two well-seasoned former senior OGDers, Marty Shimer and I, spent a few hours discussing the report and scratching our heads before we finally agreed upon what it’s really telling us.

Part of the problem with understanding the report is recognizing that actions taken and goal dates met in a given fiscal year are not always completed in the same fiscal year or by the date the report is posted.  So, if a submission with a ten-month goal date is submitted in October 2022 (the first month of FY 2023), it likely would be reported as having been met or missed in the report; however, a submission in April 2023 (the seventh month of FY 2023) would have a goal date that falls in February 2024 (which happens to be in FY 2024) and, thus, likely would not have occurred by the time this report was issued (unless the OGD acted two or three months early) and, therefore, would not be reported as having been met in the report.  To summarize, as of the December 28, 2023 report date, the OGD can only report goal dates that have been met on actions completed by December 28, 2023.  Future actions for FY 2023 submissions may still be within the relevant GDUFA III metric but could take place as late as summer 2024.  To address this challenge, the OGD provides a range in percentages that provides a forecast of submissions that will be completed on time and an early view of which metrics/goals the OGD may be in danger of missing.

Portions of the report are provided below to better illustrate examples of how to interpret what the numbers mean.  For instance, for a standard original ANDA submission, the goal date is ten months.  As of the date of the report, under Actions Completed, the OGD reported finalizing actions on 76 of the 511 applications of the FY 2023 cohort of original ANDA submissions.  In the Percent Completed on Time column, the OGD reported that 76 actions (or 93%) were completed on time, which obviously means that 7% were not.  The remainder of the 511, or 435 of FY 2023 submissions, had not yet reached a goal date.  Now we come to the column for Potential Range, which is reported as 15% to 99%.  This means that if the OGD does not meet another goal date for any of the remaining 435 original submissions, it would only have met the GDUFA goal date on 15% for the full fiscal year.  However, if the OGD can meet the goal dates on those 435 original ANDA submissions that have not yet reached their goal date, then it would have met the goal date on 99% of the submissions.  With the overall “success” rate under GDUFA III at 90%, it is likely that the OGD will meet the 90% success threshold for this metric.

Let’s look at another metric where it is most certain that the OGD will not meet the 90% success rate.

Here, on the ten standard ANDA amendments where a prior approval inspection was required, the OGD completed only 50% of this metric on time, which means that five of these submissions failed to be completed on time.  Even if the OGD meets the goal date on the remaining 36 of the 46 submissions of this type, it will only have met this metric 86% of the time, thus failing to meet the 90% success criteria.

We hope these examples will allow you to better understand the report.  Based on the note at the report’s end, it appears that the OGD will update the report periodically to reflect application status updates that take place after December 28, 2023.  Any future updates will give a more transparent view of how the OGD’s performance met the metric compliance under GDUFA III.  This report does, however, provide a crystal ball into how well the Agency is likely to perform for each of the metrics for which reporting is required.

If you have further questions regarding this report, please don’t hesitate to reach out to Marty or me at m.shimer@lachmanconsultants.com or r.pollock@lachmanconsultants.com.