November 2025 output picked up as the OGD issued 59 full-approval actions and 25 tentative-approval actions in the month. The total of 84 approval actions is the highest since June 2025 when the OGD issued 89 approval actions. It’s also an improvement over October 2025’s output of 75, the first month of the new fiscal year. Will this continue given the turmoil at CDER and the FDA in general?
We still don’t know the ANDA submission counts for other than the shutdown month, but the number coming in for November certainly has the potential to impact the long-term numbers going out as approvals. The shutdown also pushed the first possible review cycle for those applications out by at least 1.5 months from when they might have been submitted, and possibly more, and it frontloads this fiscal year’s workload into 10.5 months instead of 12. We will keep on top of the numbers for you.
As a side note, Mark Cuban recently suggested that removing ANDA application fees for domestic manufacturers could increase onshoring efforts. As reported by Kevin Dunleavy in Fierce Pharma (here), Mr. Cuban “contends his company would produce its generics in the U.S. if the FDA eliminated the fees required to secure an approved abbreviated new drug application.” This is an interesting idea as he also notes that “Each one of those [ANDA application fees] effectively costs through the FDA about $365,000. And so, if we want to add 100 drugs, that’s $36.5 million.” Now, that’s just the ANDA application fee. While this would be a nice incentive for domestic manufacturers, the $36.5 million from those theoretical 100 applications would have to come from someplace else to keep review levels where they need to be. And remember, he is just talking about the number of applications that he says his firm could theoretically submit. Mr. Cuban makes no mention of the program fees that are also associated with the GDUFA program.
Would he suggest that foreign manufacturers be charged significantly more for each application? Does he believe that Congress would pony up the money necessary to support the OGD review efforts? The days of congressionally appropriated funds to support drug-product review and the FDA seem to have passed, albeit many argue, including Secretary Kennedy, that fees paid to the FDA place the industry and the FDA in too cozy of a relationship.
There are a lot of suggestions floating around, both on the Hill and in industry, as GDUFA IV is being negotiated, but nowhere does it seem as though there is an appetite for such a significant change. Taking this fact along with the upheaval at the FDA, let’s just hope that there will be a sufficient staffing level to keep the program operating at its current level and that enough senior people will stay at the FDA and OGD to keep the ship on course. Sorry about the rant but what would be the impact on the still fragile supply chains if we costed out so many of the foreign drug manufacturers from competing in the U.S. market? What would their reaction be? Would they begin to refuse to supply U.S. drug manufacturers with their APIs and inactive ingredients? Beware the law of unintended consequences!
