The Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the first quarter of FY 2022 (here) has both good news and bad news. The proverbial question is, which one do you want first? At this juncture, I might also point out that some of the data is also difficult to assess when applying an overall perspective.
First, let me explain that the numbers in the FY 2022 report are difficult to interpret relative to past reports, which can be found at the bottom of the page on the link provided above. However, we can see there was a jump in the number of ANDAs awaiting FDA action over last year by about 100 to 1,749 from 1,661 in the first quarterly report for FY 2021. I know comparing quarters to quarters is not really an accurately way to look at the progress of the OGD, so let’s look further at longer time periods. With the number of ANDAs submitted to the OGD decreasing over the last five years, there had been progress made since FY 2018 when the number of ANDAs awaiting the FDA’s action was just over 2,000. And we saw a steady decrease in this figure over the next three years to the mid-1,600s, with one quarter actually dipping below the 1,600-mark to 1,594, until the first quarter of FY 2022, when the number rose from the mid-1,600s to the mid-1,700s. One might expect this increase if the number of ANDAs submitted had increased in the first quarter of FY 2022 but, overall, if the number submitted in the first quarter of FY 2022 continues at the current rate, the OGD is likely to see the fewest ANDAs submitted in a number of years. However, even with that said, the number of ANDAs awaiting agency actions remains high, but it has remained fairly constant over the last few years.
Mean and median approval times are very significant measures of the effectiveness of the generic drug program and are of utmost importance to industry. These numbers are also difficult to assess as they jump around from quarter to quarter and, again, general trends are, thus, the only way to discern progress. To give you an idea of what I mean, the FY 2018 mean approval time went from 41.70 months in the first quarter to 39.58 months in the fourth quarter. During the next three FYs, the mean approval time dropped to a low of 28.15 months in the first quarter of FY 2020, but shot up to 39.39 months in the first quarter of FY 2022. Does that mean that there were a lot of old applications approved for the first time during the first quarter of FY 2022? Or does it mean that approval times for all applications increased? The same can be said for the median approval time from 2018 which, for the first quarter, was reported as 41.88 months and for the next three quarters was reported in the low to high 20s (22.78 to 29.23). In the first quarter of FY 2022, the median approval time was calculated at 22.16. And while there are fluctuations in the data each quarter over the five FYs, most of the quarterly values have been in the low to mid-20s.
While I am still trying to wrap my head around the bouncing numbers, my first inclination is to conclude that, individually, they do not really provide a clear indication of significant improvement in approval times. However, if the Agency provided the year-by-year mean and median approval times, then it might be more appropriate to make some concrete assessments. I guess I’ll just keep scratching my head for now.
The GDUFA II program asked for more metrics and the OGD agreed to provide them. It could just be that what the industry asked for does not give the industry what it really wants. Maybe that was addressed in the GDUFA III negotiations, and maybe we will see more meaningful statistics starting next FY. We will see!
