From a historical perspective, I can’t remember when the turmoil at the FDA was greater, nor can I remember when the morale was lower with perhaps the exception of while the generic drug scandal of the late 80s was occurring. However, despite all the turmoil and the distractions, the Office of Generic Drugs (OGD) has had a good and productive month with regard to the issuance of ANDA approval actions. While the approval actions were high, it has also been an unusual month as I will explain.
During this first month of FY 2026, marked most notably by the government shutdown, the OGD has issued 54 full-approval actions and 19 tentative-approval (TA) actions for a total of 74 approval actions, which was, by the way, the highest total since June 2025 when 89 total approval actions (67 approvals and 22 TAs) were issued. However, the unusual aspect of this month’s numbers relates to the number of actual ANDAs that received either full or tentative approval actions; the numbers must be adjusted downward because 7 of the full approvals were for second strengths of previously approved ANDAs under the same ANDA number and 2 of the tentative approvals were second TAs for the same product. This creates a rather large discrepancy in the absolute numbers of approval and tentative approval actions versus the number of ANDAs that the FDA will post on the Generic Drugs Program Monthly and Quarterly Activities Report for October.
While we have explained this issue previously, it’s important to remind readers that the reports of “approval actions” versus total approvals will be different in each report. The OGD chooses to make this distinction in the daily approval actions to provide a credit, if you will, for the additional work that it encounters in the issuance of multiple approval actions (approvals for additional strengths or multiple TAs) for the same applications. This was the brainchild of Dr. Kathleen Uhl, former OGD Director, to give credit to the OGD for the additional effort or units of work that the approval process presents.
Anyway, one of the points that I want to stress about the first month of the new fiscal year is that the OGD, despite all it has gone through with the layoffs, resignations, rehiring, and training of new staff, along with stress of the government shutdown, is still producing a significant amount of output. Kudos to the OGD, and we certainly hope that the shutdown is resolved before much longer!
