For each FY quarter, the OGD publishes a series of metrics (as agreed to in the GDUFA II commitment letter) that identify the FDA’s workload by indicating the number of ANDAs awaiting the OGD’s action, including new ANDAs submitted each month, with separate line‑items for tentatively approved (TAed) ANDAs awaiting approval (the FDA’s current ANDA workload) and the number of ANDAs that are back with the firms after issuance of complete response letters (CRLs) (which represent the potential future workload of the OGD as responses to the CRLs are submitted), as well as the mean and median approval/tentative approval times for ANDAs.
Below is the chart (which can also be found here) that the OGD uses to provide more transparency and to inform the industry and other interested parties of its progress relative to these metrics:
|FY 2022||First Quarter OCT-DEC||Second Quarter JAN-MAR||Third Quarter APR-JUN||Fourth Quarter JUL-SEP|
|ANDAs awaiting FDA Action||1749||1712||1709|
|ANDAs awaiting Applicant TA||501||475||470|
|ANDAs awaiting Applicant Action||1607||1666||1646|
|Mean AP Approval Time – Action Cohort||39.39||34.27||31.63|
|Median AP Approval Time – Action Cohort||22.16||23.13||22.05|
|Mean TA Approval Time – Action Cohort||29.03||39.37||36.38|
|Median TA Approval Time – Action Cohort||26.68||30.32||25.38|
Looking at this table, it can be seen that the OGD currently has 1,709 ANDAs plus 470 TAed applications comprising its immediate workload. For the ANDAs awaiting applicant actions, firms in the industry are either working on or deciding whether they will respond to applications that have received CRLs. Interestingly enough, the OGD just issued a final guidance today (which we will write about next week) that discusses the one‑year timeframe required for firms to respond to or request extensions for responding to CRLs.
Mean and median approval times for ANDAs (whether for full or tentative approvals) continue to shift significantly from quarter to quarter. But the outlier for mean approval times this quarter goes to mean TA approval time (36.38 months). This metric, while consistent until the third quarter of FY 2021 (36.67 months), is still much higher than the fourth quarter of FY 2021 (29.62). Why this occurs is not exactly clear, but it could have something to do with a few older ANDAs getting TAed for products that still have a fairly long patent life on the RLD. As we can see from the table, the mean and median approval times for full approvals (and, for that matter, the median approval time for TAed applications) seem to track more closely from quarter to quarter with much less difference.
Anyway, we will be back at you next week with some more (hopefully useful) information and insight on what’s going on at the Agency. Have a great weekend!