Almost two and a half months after the beginning of FY 2024, the first month of FY 2024 (October 2023) statistics appeared, almost like a Christmas present! And from the looks of the numbers, there is likely some coal in some of the statistical “stockings.”
Let’s start with the Original ANDA approval numbers. The OGD did pretty well in this category as it issued fifty-seven full-approval actions (one less than the fifty-eight issued in October 2022 (the first month of FY 2023)), which puts us on an even footing for last year. Of the fifty-seven full-approval actions, four were for first-time generic approvals and ten (17.5%) were for first-cycle approvals, and there were six imminent approval actions, which will hopefully show up as approvals in the coming months. As far as tentative-approval actions are concerned, the OGD issued sixteen, of which four (25%) were first-cycle TAs and four were imminent-approval actions. Thus, the total of approval actions for October 2023 was seventy-three.
The number of complete response letters (CRLs) issued in October was 141, a bit below the 148 issued last October, but higher than the FY 2023 monthly average of 123. The OGD issued four refuse-to-receive letters to ANDA applicants, all of which were standard (not priority) applications, and it acknowledged thirty-three new ANDAs, which is consistent with the low number of acknowledgements last October (twenty-six). On the other hand, the OGD issued 203 prior approval supplement (PAS) approvals, which far exceeded the FY 2023 high of 159 that occurred in March 2023.
There were 336 information requests (IRs) sent in October, with 135 going to original ANDAs and 201 issued for supplements. An interesting note is that, in all but one of the months in FY 2023, the number of originals receiving IRs was higher than the number of supplements receiving IRs. We will need to see whether this reversal continues in the coming months as it could point to a significant change in workload for the OGD and OPQ relative to supplements vs. original applications. The OGD also received a total of 947 supplements (818 changes being effected (CBE) supplements and 129 PAS), which is on the high side compared to a FY 2023 monthly average of 852, which may also support the shift in workload to supplemental ANDA reviews over original ANDA reviews.
The OGD issued 193 discipline review letters (DRLs) in October, close to the FY 2023 monthly average of 205. DMF completeness assessments soared to eighty-four in October, significantly higher than any month in FY 2023, during which the highest number of assessments in any month was fifty-two. It appears that manufacturers may be seeking new API sources for older products and possibly for some of the newer products that are becoming available for generic competition in the not-too-distant future.
Now here comes the concerning news, the OGD received only twenty-six new ANDAs in October 2023. This was far and away the lowest number of ANDA receipts since October 2021 (FY 2022). October is usually a slow month for submissions for two reasons: (1) the firm’s year-end rush to submit ANDAs to meet internal goals; and (2) the increase in user fees in the new fiscal year drives submission to the September time frame. However, the September 2023 submissions totaled only seventy-three, which is the lowest number of the September submission rush in the previous three FYs. Hopefully the coming months will show a rebound in the number of original ANDA submissions. We previously posted about our concern with the drop in original ANDA submissions and the potential reasons for the decline here.
The OGD received 211 amendments in October, with almost a 50/50 split between major and minor amendments. In addition, there were 264 controlled correspondences (CCs) submitted during the first month of the new FY, well below last FY’s average of 305.
The number of pending ANDAs awaiting FDA action dropped to 1,477, well below the lowest (1,531) the previous FY. This trend appears to be continuing into this FY as the total number of ANDAs awaiting FDA action has been steadily dropping over the last five months. The number of ANDAs awaiting applicant action stood at 2,056 at the end of October 2023, which matches the September 2023 number. It must be noted that there also appears to be a similar decreasing trend in the number of ANDAs pending with applicants. We will keep an eye on these two important metrics as it appears that both numbers are trending downward, which could speak to a decreased workload at the OGD and a corresponding decrease in applicant submissions.
The entire statistical report for the first month of FY 2024 can be accessed here.
Some surprises and some concerns could bring short-term benefits in terms of faster approvals but long-term consequences in terms of funding and staffing at both the OGD and OPQ. Keep your eyes open and let me know what you think at r.pollock@lachmanconsultants.com.
