At the end of August, we noticed that all of the ANDA approvals were not appearing on the FDA Daily Approval Listings (here), nor were they appearing on the FDA All Approvals Report (here). In September, it got worse, with less than half of approvals showing up (we believe). It appears that the problem has not yet been fixed since, in October to date (October 13), the databases only report sixteen approvals and two tentatively approved approval actions. Based on past historical data, this is a very low number at halfway through the month.
At the end of September, the FDA did acknowledge that there was a problem, albeit it did not say exactly what the problem was (see previous post here). One might think that since everything has been working for the last couple of years, with all approval actions appearing and a concordance issue between the two lists solved, that with a sudden change that the problem would be an easy fix.
Now, it might seem like I am harping on the FDA for no real reason because, after the end of each month (usually within ten to fourteen days), the official approval action numbers are posted on the most current FY Activities Report of the Generic Drugs Program Monthly Performance (here). So why don’t I just wait and not be so concerned about this apparent glitch and the monitoring of approval actions throughout the month? Well, it is because approval actions are perhaps the most important metric that the industry has to gauge the OGD’s and OPQ’s performance. It is also a metric that keeps industry CEOs up at night, especially when the transparency to this metric diminishes suddenly.
The Daily Approvals List and the All Approvals List provide close to a real-time report card on the OGD’s progress on approval actions on an almost daily basis. Waiting for an accurate count of the monthly total some two weeks or more after the close of the month does not give the industry time to react, nor does it give a hint of slowdown with approval actions (like what occurred with the elemental impurity approval slowdown).
I know, as a Hatch-Waxman nerd, a former acting Deputy Director at the OGD, and, currently, as a very interested industry representative, that this information is critical to daily decisions of the industry. Hopefully, the FDA can tell us why this problem has occurred, why it has taken two months to fix something that was not previously broken, and when the issue might be resolved.
