As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on no hands! That’s because after October 1, 2025, without a new appropriations bill or continuing resolution being passed, the FDA cannot accept or process any submission requiring a fee. Hey, don’t blame me, I am only the messenger!

In that regard there are no new NDAs, BLAs, ANDAs, biosimilar applications, device PMAs, 501Ks, OTC OMAR submissions, tobacco submissions and on and on, that require a fee submitted in FY 2026 because the FDA can’t accept them. So, as the FDA works on improving efficiencies, making policy for expediting onshoring drug product manufacturing, and issuing Commissioners Priority Review Vouchers, no fee-paying submission can be accepted by FDA until the stalemate in Congress is resolved.

As we reach the end of October, it seems that people are just starting to realize this fact. A number of industry representatives at the AAM’s GRx-Biosims conference, that concluded yesterday, were completely oblivious to this fact and responded, “are you kidding me?”. What is worse is that the full range of implications that the delay in submissions creates for first-to-file ANDAs, patent certification notifications, and a host of other issues that are raised by the inability to timely submit an application (and will impact industry) have not been fully articulated. It certainly will provide the FDA law bar with a number of interesting cases to litigate as the shutdown continues and more of these issues come to light.

So as those fee-paying submissions back up in the hands of sponsors, who in Congress will be the first to blink? I am not even sure that this specific FDA issue has their attention. Oh yeah and here is really bad news! FDA only has so much money in reserve as they continue to work on non-fee related submissions and fee-paying submissions submitted prior to October 1, 2025. Once that money runs out, with some estimating mid-November 2025, then it becomes a full stop on FDA activities. Maybe we should let Congress know we are not happy campers!