New Footnote Raises Questions About Approval Numbers

As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report.  It reads:

++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications, including split approvals (final approvals of certain strengths in an ANDA at the same time that certain other strengths are tentatively approved) and subsequent tentative approvals of applications that have previously been tentatively approved.

After reading it a few times, I started thinking, has our understanding of the reported approval actions been correct over the recent years?  There have been some obvious changes in the reporting of ANDA approvals over the years, but those have been more transparent (at least I think they have).  For instance, after the passage of Hatch-Waxman, separate ANDAs were submitted for each strength of a product.  Sometime in the early 1990’s, FDA began collapsing multiple ANDA strengths into a single application. But there were also exceptions to that rule (e.g. when there was a potential for an ANDA submission for a new strength submission to delay an already submitted strength in an earlier application).  Now we learn that the report of approvals may not be exactly what it seems.  For instance, tentative approvals may revert back to a pending application if a sponsor amends the tentatively approved application with new data or makes changes in the ANDA; then, when the review is complete and acceptable, another tentative approval (TA) letter issues. That means that the TA count for approvals increases but the number of TA’ed ANDAs stays the same (kind of a 2 for 1 or 3 for 1 etc).

Split approvals are also now counted differently (as explained in the footnote), so approval actions for a single application may be reported multiple times.  I am not sure what this does to the final approval numbers in terms of industry being able to accurately track individual ANDA approvals, but it certain dampens the enthusiasm for the term “record breaking approval month”.  Now, that does not mean I do not understand the Agency wanting to take credit for the extra work it must put in to manage the ANDA approval process and deal with these special situations, but what does that leave industry with in terms of fully being able to understand what the numbers mean?

Will the Agency “true up” its approval totals at the end of the year to report total ANDAs approved or tentatively approved? Or is the industry to begin to accept the reported approval numbers as approval actions rather than application approval totals?  This is something that is well above my pay grade but should be discussed at all levels of the industry and eventually with the Agency.