The FDA updated the full FY 2020 stats sometime overnight and now we have a clear picture of how the FY shaped up.  While it is not somewhere over the rainbow, it appears to be the new normal and that’s not too bad.  Let us take a look!

First, the Refuse-to-Receive (RTR) numbers are down significantly over the first eight years of GDUFA.  There were only forty-two RTRs issued in all of FY 2020.  This indicates that ANDA quality has improved greatly over the eight-year learning curve.  The chart below shows the progress that has been made by industry but remember that, in FY 2015, more stringent requirements for the issuance of RTRs were put into place so the sharp rise in the number of RTRs in FY 2015 was a direct result of the screws being tightened.

Fiscal Year Number of RTRs
2020 42
2019 52
2018 127
2017 142
2016 246
2015 236
2014 173
2013 150


We have previously reported (here) that the number of full-approval actions for FY 2020 was 737 (an average of 61.4/month), as compared to last year’s 935 (average of just under 78/month).  Of the FY 2020 approvals, there were seventy-four first-time generics and 122 first-cycle approvals (FCA), representing a 16.6% FCA rate.  This is a number that the OGD has got to improve over time and perhaps, with GDUFA III negotiations now ongoing, this will have some impact on raising the first-cycle approval rate in the future.

Complete response letters (CRLs) fell to their lowest level (2,010) in more than three years in FY 2020.  The prior two FYs saw the issuance of 2,310 and 2,648 CRLs.

Information Requests (IRs) bumped up in FY 2020 to 4,277 from 4,162 in FY 2019 but was far below the 4,452 seen in FY 2018.  Discipline Review Letters (DRLs) dropped in FY 2020 to 2,568, down from the FY 2019 total of 2,997 but up from the FY 2018 total of 2,048.

The biggest news is that new, original ANDA submissions have declined for the third year in a row, with 865 new ANDAs in FY 2020, 909 in FY 2019, and 1,044 submitted in FY 2018.  Some of the decrease is likely due to consolidation in the industry and perhaps a slow year for first-to-file opportunities.  However, as in the past, there are new firm names appearing in the recent approval listings.  The big players get gobbled up and/or merge and the new players begin to seed the growth and reshape the industry, and, thus, the cycle of generic players continues to perpetuate itself.

The growth in CBE supplemental submissions is taking off.  In FY 2020, there were 9,660 submitted, which is a sharp increase from the previous two FYs (8,017 and 6,488 respectively).  Could this be attributed to changes necessary to be able to scale up to proposed commercial batch sizes or some other issue?  Unfortunately, there is no way to know what is driving the increase in CBEs as the Agency has not released any information about the nature or purpose for these supplements by category.  PAS submissions, while up to 1,133 in FY 2020 from last FY’s 889, appear to be in line with other FYs, as the total of PASs submitted in FY 2018 was 1,103.

The big news is that, every year since the inception of GDUFA, the number of controlled correspondences (CCs) have increased and a dramatic increase it is this time.  In FY 2013, there were 953 CCs submitted to the OGD and, in FY 2020, there was a staggering total of 3,596.  In my thinking, there is a real disconnect between the ANDA quality improvement seen from the large decreases in the issuance of RTRs and the explosion in submitted CCs.  What is driving this need for this ever-increasing questioning of the OGD’s policies and procedures, regulatory questions, and filing questions?  From my perspective, the industry is getting more risk-averse and wants confirmation or clarity for anything that is slightly out of the ordinary or is not specifically addressed in an FDA guidance or regulation.

Well, all-in-all, FY 2020 appears to be about as normal as it could be in the face of the pandemic and the volatile political atmosphere.  Hopefully, FY 2021 will show better progress and a more stable environment.  Since I have provided only the highlights and areas that may need more noodling, you can access all of the fiscal year data provided in the report noted above since the GDUFA era began here.  Happy hunting for your statistics of choice!