Overnight, FDA updated its metrics for August and also provided some critical metrics to end out FY 2021 (here). Let’s take a look at the August update first.

OGD issued three (3) Refuse-to-Receive letters in August, which appears to be consistent with the numbers for the year (with the exception of 11 RTRs that were issued in May). The Agency acknowledged 58 new ANDAs and (not a big surprise) there were 105 ANDAs withdrawn in August, 100 of which were approved ANDAs, a potential move by firms, prior to the start of FY 2022, to perhaps move into a lower program fee category.

Of the 55 ANDA approved in August, 10 (or 18%) were first cycle approvals and there were no first cycle approvals for the 8 ANDAs that had received a tentative approval action. OGD issued 353 information requests and 184 discipline review letters with both metrics in line with the monthly averages of 363 and 178 respectively, reported through the first 11 months of FY 2021. The changes being effective supplements (671) fell off the monthly average of 792 and prior approval supplements (105) were in line with the monthly average of 111 for the first 11 months.

Controlled correspondences were at 374 the second highest total for a month behind March’s high for the year of 402.

Now we will take a look at the September numbers for approval actions, tentative approval actions, complete response letters, and new ANDA receipts and provide the full FY 2021 totals.  As noted in our post of October 6, 2021 (here), there were only 39 full approval actions in September, the lowest for the year.  When looking at the year 2021 full FY, OGD managed 679 full approval actions, a number not seen since the 651 in FY 2016. There were 10 tentative approval actions in September (we reported three (3) in our blog post, not sure why the other seven (7) did not show up at the time) and the total tentative approval actions for FY 2021 were 157 the lowest since FY 2015.  Receipts of original new ANDAs have dropped considerably, and it is not until we look back to FY 2015 that we see fewer ANDA received in a given FY. See table below for the OGD full approval actions, tentative approval actions and ANDA receipts since the inception of GDUFA.

FY Approval Actions Tentative Approval Actions ANDA Original Receipt
2021 679 157 809
2020 737 172 865
2019 935 236 909
2018 781 190 1044
2017 763 174 1306
2016 651 184 852
2015 492 120 539
2014 409 91 1473
2013 440 95 968


In addition, OGD issued 152 complete response letters in September (monthly average for FY 2021 was 154, so that metric tracks well during this FY.

We are seeing a slowdown in receipts as well as a slowdown in approvals. Factors that could impact these trends could be the continued consolidation in the industry, competitive drug targets diminishing, pricing pressure in the industry, and the ever-shrinking margin available for manufacturers in the supply chain.  Firms may be looking at the more complex generics where the barrier to entry as well as the reward may be greater, but whatever the factors that are in play, the increase cost in doing business with the FDA (e.g., user fees) cannot be helping the situation and may be edging smaller competitors out of the game. While the Agency says they are at steady state, if these figures continue on a downward trend, it could spell trouble for the generic industry as a whole.