In the News: FDA Announces New ANDA Prioritization Pilot

On October 3, 2025, the U.S. Food and Drug Administration (FDA) announced a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs) that aims to spur and reward investment in U.S. drug manufacturing and R&D and strengthen the domestic pharmaceutical supply chain. The aim is to provide faster reviews as an incentive for generic companies who test and manufacture their products in the U.S.

More than half of pharmaceuticals distributed in the U.S. are manufactured overseas. Further, the U.S. is reliant on overseas sources for active pharmaceutical ingredients (APIs). As 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. due to the conduct of these studies being less expensive in non-US CROs, weakening the U.S.’s pharmaceutical R&D infrastructure.

The objective of this new pilot prioritization program is to reduce reliance on foreign drug manufacturing and testing which creates risks both to national security and patient access to medications, and undermines investments in US research, manufacturing and production, according to Dr. George Tidmarsh, Director of FDA’s Center for Drug Evaluation and Research. It also slows down regulatory reviews and costs taxpayers more money, as these foreign research and testing sites must be inspected by FDA, and foreign inspections take more time to prepare for and are more expensive to conduct than domestic inspections.

This pilot prioritization program aims to ensure that Americans have a strong and resilient domestic drug supply, and also reflects the Trump Administration’s objective to revitalize American industry.

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. Applicants can request this priority review by following the procedures outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (“Prioritization MAPP”) and referencing this pilot program as the basis for prioritization.

Applicants should provide information with their priority review request to demonstrate that their ANDA qualifies for the pilot:

(1) that either the pivotal bioequivalence testing was conducted in the U.S. or that the ANDA qualifies for a waiver of bioequivalence testing;

(2) that the finished dosage form manufacturer is located in the U.S.; and

(3) that the API supplier is located in the U.S.

Prioritizing this additional category of ANDAs is expected to expedite the availability of high-quality, U.S.-made generics for American consumers.