On October 3, 2025, FDA announced a new “ANDA prioritization pilot (which) represents a further step FDA is taking to incentivize U.S. generic drug manufacturing and testing. Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the United States and whose products are made in the U.S. using exclusively domestic sources for APIs are eligible for priority review.” How realistic is this trifecta for manufacturers likely occur? While it might provide a long-term incentive, finding a US manufacturer that conducts bioequivalence testing in the US, manufactures its entire product in the US, and uses domestic active pharmaceutical ingredients (APIs) manufactures (not just suppliers) in the US, may just about be a unicorn in today’s generic drug market place. According to the FDA announcement of the pilot program (here), “[A]s of 2025, only 9% of API manufacturers are in the U.S., compared to 22% in China and 44% in India. In addition, pivotal studies for drugs, including bioequivalence testing for generic drugs, are increasingly conducted outside the U.S.”

Putting the three components of the program together to secure a priority review seems more like a long shot at this time than a home run to build the type of strong domestic supply envisioned by the program. Hey, we are not knocking the goal or the program, we think it is lofty but there are also a lot of costs associated with building the three-legged chair required to qualify for this type of priority review. Most foreign APIs are much less expensive than those available in the US, if they are available at all. Also in vivo bioequivalence testing can, in some instances, cost less than half the cost associated with using a US CRO.

FDA says in its notice that “This pilot prioritization program can help ensure that Americans have a strong and resilient domestic drug supply and also reflects the Trump Administration’s unwavering commitment to revitalizing American industry and providing American consumers affordable access to needed medications.”

So, if the program is to work, there must be a huge incentive. However, the incentives cited in MaPP 5240.3 Rev. 6 (here) do not explicitly outline any new conditions or timelines for priority review under the pilot program. The pilot offers the chance for priority review, but we believe that sponsors would want to know just what that meant in terms of shorter GDUFA goal dates or review time for completion of these priority reviews. It is not unreasonable for generic applicants to expect a quicker review timeline for an ANDA that satisfies all of these criteria since all of the critical inspections would be taking place within the United States, where FDA does not have to contend with scheduling and visa issues that apply to many foreign inspections.

As more onshoring takes place, perhaps the program would more broadly apply to a larger number of applicants. Now however, in our opinion and knowing what we know about the generic drug industry, there are few sponsors that would be able to meet the qualification thresholds for participation in the pilot program at this point in time.