In the post that was published yesterday (here) regarding the statistics for the first six (6) months of FY 2023, I promised to provide some OGD trends. And I failed to deliver. I guess when the pedal is pushed down too hard, and you are going too fast you get to the next intersection before you have a chance to fully enjoy the scenery around you! So here is some of what you should have also seen in yesterday’s post.
At the current rate of approvals, we can now expect that OGD will issue full approvals on 736 ANDAs at the end of FY 2023. Over its existence, the GDUFA program has seen some ups and downs. Below is a chart that provides a history of approvals over the last 10.5 years of GDUFA. It is interesting to note that, while the staffing of OGD and OPQ has continued to rise, the large increase in approvals evident in the early years of the ramp up of the program has remained fairly constant since FY 2017, with the exception of 2019 which saw a record number of approvals (935) under GDUFA. The tentative approval estimate for FY 2023 currently stands at 190. And again, we see the same basic trends that we notice for full approvals where we see FY 2019 with the highest number of TAs at 236.
Approvals by FY
|Fiscal Year||Number of Full Approvals||Number of Tentative Approvals|
Looking at the chart, the following question springs to mind – what happened in 2019? Was it the proper balance of staff to workload that prompted the most productive year under GDUFA? Did ANDA requirements increase after FY 2019? Or did the other work and additional responsibilities taken on by OGD in the GDUFA negotiations eat up too much review time? All interesting questions but those would be questions best posed to the FDA or to an outside business consulting firm.
Other big item trends that we follow includes Complete Response Letters (CRL) which are projected to hit 1668 by the end of FY 2023, compared to 1811 in FY 2022, with the two highest years being 2019 (there it is again) and 2018 when 2310 and 2648 CRLs (respectively) were issued.
We note that there is an increasing number of application touch points, meetings, and telephone conferences that have been instituted over the three iterations of GDUFA and one of the big issues that may be impacting the trend in approvals might be the issuance of information requests (IRs) and discipline review letters (DRLs). Based on the figures so far this FY, it is estimated that OGD will issue 3908 IRs and 2514 DRLs by the end of FY 2023. Compare this to 4370 IRs and 2484 DRLs issued in FY 2022. FYI, the highest number of IRs issued was in 2018 (4452) and DRLs highest issuance was once again during the prolific FY of 2019 (2997). Remember, the IRs and DRLs were first implemented in the second iteration of GDUFA which began in FY 2018.
We also project controlled correspondence (CC) receipts to be at 3614 by the end of FY 2023. The highest years for CCs have been FY 2021 (3897) and FY 2022 (3732), which to me likely means that the either the industry remains gun shy and still wants their questions answered in writing or that there is still a lack of clarity regarding the contents of guidance documents and/or a full understanding of FDA expectations, which I like to call the FDA moving target syndrome.
So that is a roundup of some of what I view as important OGD trends and provides some interesting questions to ponder. If you have any thoughts on the rundown or any of the questions, or have more questions to ask, feel free to contact me at email@example.com. Have a great weekend!