The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics.  As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response letters issued, before some of its other monthly reported statistics (see previous blog post here), then about two weeks later it provides additional metrics after they are reviewed and verified.  So, let’s look at some of the newly reported numbers!

In January, the OGD issued a single refuse-to-receive (RTR) action.  It looks like the industry is getting better and, as you may recall, last month was the first reported “0” for RTR actions.  Hopefully, this trend will continue.  Of the sixty-two ANDA approval actions, seventeen or 27.4% were reported as first-cycle approvals.  This is a much-improved percent of first-cycle approvals, although the number bounces around too much to see any real trends.  Of the eight tentative approval actions, one or 12.5% was a first-cycle action.  Information requests (307) and discipline review letters (131) both had the lowest number of such actions thus far this FY.

On the industry side, we previously opined on the lower number of ANDA submissions in the blog cited above.  However, we are seeing some additional directional trends that may be troubling.  ANDA amendments (179) fell to the second lowest of the FY 2021.  Last year, the average number of amendments submitted per month was 234.  This appears to either be a slowdown in the industry responding to complete response letters or an increase in first-cycle approvals.  Or it is possible that, as the number of information request and discipline review letters are being dealt with by industry, they may be prioritizing their amendment responses based on the importance of the product.  It is also possible that responding to some of the Agency’s requests in CRLs is taking longer than expected.

Also, on the industry side, in January, the prior increases noted in the submission of CBE supplements has reversed, with 611 being submitted.  This is well below the 950+ per month seen in the first two months of the year and even the 787 seen in December.  Is it possible that COVID’s impact on supplemental submissions is decreasing?  At the same time, controlled correspondences stay above the 300 mark at 339 for January, the highest monthly total thus far this FY.  To me, it is clear from what I hear from my industry friends, that the industry is still reluctant to take a chance in making a decision on something out of the ordinary, or on some issue they previously would have moved forward with absent a controlled correspondence request, without getting something in writing.  This may because the FDA has been less predictable over the last couple of years and the industry is afraid to go out on a limb.

The numbers are, of course, only for the first third of FY 2021 and it may be too early to establish a real trend, but they appear to be trying to tell somewhat of a story.  We will have to continue to listen to them in future months to decide whether it is a story we are glad to hear or not!