Once again, with October approval action postings surprisingly low, I confirmed that the FDA is still having trouble with its internal IT systems that generate this information and populate certain databases. While it does not appear to be impacting data regarding NDAs, the ANDA postings are spotty at best.

The word came back from OGD through the FDA press office that “We’re aware of the technical issue with” the postings “and are working to resolve it.” While it is reassuring that approvals are being issued, it is disappointing that there is no transparency for those numbers at the moment, particularly now, at the end of the FY and the beginning of the new one. I specifically asked if OGD could release the numbers for September approvals but I got back the expected reply: “We won’t be able to provide the September numbers until they post publicly.” While I understand that, I’m surprised that there is no other mechanism that OGD could use on a temporary basis to publicly alert the industry to its approval action figures for the final month of FY 2023.

With approvals being the life blood of the generic industry, and the bellwether for the success of the FDA’s generic program, those figures are essential for decision making in the industry. With the calendar rapidly moving towards November, the industry is operating without this information. Hopefully the FDA’s computer issue will be fixed shortly, but I will continue to be the squeaky wheel until the problem is resolved.