Not sure what is taking the FDA so long to fix the system “glitch” in reporting ANDA approval actions, but this has been going on for quite a while. Here we are, the day before Thanksgiving, and there are only 14 full ANDA approval actions and 9 tentative approval actions listed in the available FDA databases. We know that is nowhere near the productivity of OGD in issuing approval actions, but it is the only thing that we are able to see from the outside.
Some might say, what’s your hurry, the official numbers will be posted soon! Well, this is a critical number for the generic drug industry as well as the investment community. Tracking approval actions gives a sense that the program is working. In the past, approval actions have been posted daily in two public places, in the Recent New and Generic Drug Approvals page (here) as well as on the All Approvals and Tentative Approvals page (here). The former provided a 7- or 14-day look back at actions and the latter provided up-to-date data for each month and is searchable by month. The numbers for NDA actions are now (as always) appearing the day after approval, but for some unknown reason, ANDA postings have lagged. We are almost 2 full months into FY 2024 and the industry has no accurate view into the activity that has taken place regarding ANDA approval actions.
As previously reported, this is not the first time that this problem has occurred. If I remember correctly, the last void in reporting ANDA approval actions lasted about 4 or 5 months. This current “glitch” goes back to the end of August 2023. Fixing it must either not be a priority of the Agency or maybe I am the only one concerned? Let’s hear your take on the importance of having a transparent view of ANDA approval actions. Send comments to r.pollock@lachmanconsultants.com; your identity will be protected. And if you know of a good IT person, you might consider sending their resume to the Agency!
