Final Metrics Posted for OGD’s Full FY 2021

On Friday afternoon, the OGD posted the remainder of the metrics for the last month of FY 2021.  While we know what the approval statistics were for the full year, along with the comparisons for previous FYs since the inception of GDUFA (see previous blog post here), there are other interesting metrics that need to be discussed.

For FY 2021, the OGD refused-to-receive 46 ANDAs, which is consistent (within a handful of applications) with the previous two FYs, but substantially lower than the high of 246 ANDAs that received the same fate in FY 2016.  Other numbers appear around the 150-mark or slightly higher.  This shows that the industry is getting it right more often and that the process for initial information requests (IRs) during initial completeness and acceptability reviews is working to keep those numbers down.

The OGD acknowledged 736 new ANDAs, while it received 809 ANDAs in FY 2021.  When you realize that those ANDAs received in September and August totaled 186 applications, this difference makes a lot of sense and is to be expected since there is a sixty-day window for the initial completeness and acceptability reviews.  As noted in the blog post cited above, the OGD approved a total of 679 ANDAs in FY 2021 so receipts outpaced approvals by 130 applications.  First-cycle approvals (which are, in my opinion, the most critical metric for success of the generics program) were at 17.4% for the full year (121 first-cycle approvals and 679 approvals).  This number needs to continue to improve dramatically or the median and mean approval times will continue to be in the thirty- to thirty-four-month range.  First-cycle approvals for tentative-approval actions were 12.1% (19 first-cycle approvals of the 157 total tentative-approval actions for the year).  The figures for first-time tentative-approval actions are not likely very instructive because the FDA may report multiple tentative-approval actions for the same ANDA if the TA switches to pending after an amendment and then gets a second or third TA letter.  We do not have a firm grip on what that difference might be, which could negatively impact the percent of first-cycle approval calculations for TAed applications.

IRs for FY 2021 stood at 4,313, with discipline review letters (DRLs) reported to be 2,230.  Statistics for IRs and DRLs were reported beginning in FY 2018 under GDUFA II.  The high for IRs for any of those four years was in FY 2018 with 4,452 being issued, and for DRLs it was FY 2019 with 2,997 issued.

Supplements present another picture, with changes being effected (CBE) supplements increasing year after year (with the exception of FY 2021) and PAS supplements increasing every year during GDUFA II, as represented in the chart below:

The workload is significantly increasing in the supplements area while the number of ANDAs submitted slumps.  In essence, this make sense because the more ANDAs that are approved and marketed, the more targets there are for potential required changes!

As far as controlled correspondence goes, FY 2021 saw a record breaking 4,009 submissions.  The number of CCs has increased each year in GDUFA II as depicted in the chart below:

The continued increase in CCs submitted to the Agency, I believe, reflects the industry’s risk-averse attitude towards doing something that might be somewhat out-of-the-ordinary for fear that what they think is correct may not comply with the OGD’s expectations.  The higher number of CCs might also reflect either the FDA misunderstanding the industry’s CCs or the FDA giving either incomplete responses or ones that do not actually answer the question, requiring second or third CCs for the same issue.  One firm I am familiar with required six CCs to resolve what seemed to me to be a rather a straightforward issue.  Replies like “this is explained in a guidance document” may not help as the sponsor obviously can’t make heads or tails out of the guidance document based on their own unique situation and are seeking assurance that their approach or question is satisfactorily answered.  Hopefully the changes discussed in the GDUFA III commitment letter will help with this issue, but we are still one year away from implementation of those changes.  As I have said many times, there needs to be a more efficient feedback system for CCs when there is confusion; let’s hope that the GDUFA III enhancements will help with this ongoing problem.

The remainder of the FY 2021 metrics can be seen here and, for comparison purposes, there are links to each of the FYs since GDUFA’s implementation.  (Just remember that there are some differences in metrics reported in GDUFA I and GDUFA II.)  Enjoy!