With the end of the 2022 fiscal year, it is always good to take a look back at how the metrics for the year are viewed. While some of the comments in this blog may be mine and mine alone, I think that you all agree with me. If not let me know!
We have already addressed the approvals, new ANDA receipts, and the number of complete response letters (here) so I will only address then in passing in regard to the new metrics that appear in the update.
In that regard, the number of first cycle approvals for September and the entire FY are important given FDA efforts to improve first cycle approvals in GDUFA III, so these number could be considered to the floor for the success of GDUFA III’s efforts. In September of the 68 full approval actions, eight (8) (or 11.8%) of applications are reported to be approved in the first cycle review. For the full fiscal year of the 722 full approval actions, 130 (or 18%) of the full approval actions were first cycle approvals. While the 18% is about the same as the 17.8% in FY 2021, this metric needs to significantly improve in the next 5-year GDUFA cycle for success to be declared. For the nine (9) tentative approval actions for September 0% were tentatively approved in the first cycle. For the full 2022 FY, of the 183 tentative approval actions, 14 (or 7.6%) were tentatively approved in the first cycle. This is compared to 12.1% of the ANDAs that received a first cycle tentative approval action in FY 2021. A significant decrease. But again, I don’t give much credence for this difference because there are a lot of issues with TA’ed applications such as patent, exclusivity, complex generics etc., that might not impact full approvals.
There was a total of 4370 information requests for FY 2022 compared with 4313. Really not much of a difference. For discipline review letters (DRL) FY 2022 saw the issuance of 2484 compared to FY 2021’s issuance of 2230 DRLs, and increase of about 9% in FY 2022.
Amendments FDA received in FY 2022 totaled 2513 and in FY 2021 that number was 2536, just about no difference. This could represent almost what one might call a steady state in industry’s rate of response to CRLs.
For changes being effected (CBE) supplements OGD received 8426 in FY 2022 and a whopping 9557 in FY 2021. This could represent a slowdown in workload for the Office of Product Quality (OPQ) that supports OGD’s chemistry reviews. Prior approval supplements received in FY 2022 totaled 1296 and in FY 2021 there were 1351, a slight decrease in workload and for many PAS supplements there is a greater resource burn required to review these over CBE.
The last metric I would like to highlight is that related to controlled correspondences (CC). FY 2022 saw 3732, while in FY 2021 OGD received 3897, while a small drop, this does show that CCs are not going away and represents a fairly large resource commitment give the goal dates association with CCs.
Please see the Generic Drugs Program Activities Report – Monthly Performance (here) for full details and you can navigate through FY 2013 through FY 2021 at the bottom of the FY 2022 report. Make you own comparisons over the 10 yeas of GDUFA and reach your own conclusions. We will keep a close track on how the GDUFA III enhancements impact the first cycle approvals and mean and median ANDA approval times that are certainly the metrics that are most important to the generic drug industry.
