More December 2021 Stats Posted and a Look-Back at Approvals and Receipts

Here we are in February 2022 and the FDA has updated the full report of statistical metrics for December 2021.  Let’s take a look at some metrics of interest.

We are three for three – for refuse‑to‑file (RTR) actions, that is.  Each month in FY 2022, we have seen the OGD issue three RTR actions.

The OGD acknowledged forty‑five ANDA applications in December.  Of the thirty‑four ANDAs previously reported as fully approved, four (11.8%) were first‑cycle approvals.  Two (9%) of the twenty‑two tentative approval actions were approved in the first cycle.  First‑cycle approval percentages for full- and tentative approval actions are both well below what we have seen in recent months, with the numbers generally in the 15‑20% range.

The number of information requests (IRs) issued by the OGD/OPQ in December (308) was the lowest since January 2021 when 307 were issued.  In most months, we saw the numbers of IRs issued in the upper 300s or low 400s.  The number of discipline review letters remained consistent this month with the FDA issuing 202.  Amendments to ANDAs also remained consistent with previous months in FY 2022 with the FDA reporting 236 submissions, which is the high so far this FY.

Changes being effected (CBE) jumped back to the 800s with 821 submitted, up from last month when the FDA received 753.  Prior approval supplements (PAS) received for the month totaled 114, which is around the usual number.  The workload in the Office of Product Quality, thus, remains high with the number of supplemental submissions coming into the Agency.

The number of controlled correspondences (CCs) dropped dramatically to 252 in December 2021.  We have to go all the way back to January 2019 to see a lower number (244).  There is no indication that there has been a general slowdown in CCs being submitted to the Agency; we believe that this may be a one-off month for this metric.  But perhaps, with all of the FDA guidances being issued, especially the Q&A documents, and the number of webinars that the OGD is holding, maybe, just maybe, the industry is finding more answers to their questions from these sources lately.

Now, since we have the ANDA approvals and receipts for the first quarter of FY 2022, let’s take a look at projections for the full FY.  If the trend says the same, we can expect the OGD to receive 840 ANDAs and fully approve 600 ANDAs in FY 2022.  The number of approvals has not been that low since FY 2015 when the OGD approved only 492 ANDAs.  As for receipts, the projected total will exceed the 809 from last FY year.  As we stand right now, it looks like the number of approvals may be trending downward and the number of submissions may be trending upwards.  Here is what the history of full approvals and receipts looks like for all of the years of GDUFA:

*- projected

Some observations regarding the numbers in the above table:

• There has only been one year since the inception of GDUFA that the number of approvals has exceeded the number of receipts.
• The number of receipts has dropped off in the last few years, which could have something to do with consolidation in the industry. Hopefully, with smaller firms beginning to enter the market, that number will increase.  Part of the decrease is also attributed to some larger firms concentrating more on complex products, which will likely have less competition due to the scientific barriers to entry (and, thus, higher profit margins) and dropping some of their attention to commodity‑type products.
• It is difficult for me to understand why the approval numbers are trending downward while the OGD/OPQ staff size continues to increase and the number of submissions has leveled off over the past three or four years.

Let’s see how the year plays out.  What I can tell you for certain is that there was a rather large flurry of approvals at the end of January, but I will wait a couple more days for all of the OGD approvals to be posted before I put in my guess as to what the official totals will be for the month of January.  The full statistical report can be found here.