FDA launches pilot program to prioritise review of U.S. made generic drug applications

The U.S. Food and Drug Administration (FDA) has announced a new pilot prioritisation program for the review of abbreviated new drug applications (ANDAs). The program is designed to support investment in U.S.-based drug manufacturing and research and development, and to strengthen the domestic pharmaceutical supply chain by offering faster reviews to generic drug companies that conduct testing and manufacturing in the United States.

According to the FDA, more than half of pharmaceuticals distributed in the U.S. are manufactured overseas. As of 2025, only 9 per cent of active pharmaceutical ingredient (API) manufacturers are based in the U.S., compared to 22 per cent in China and 44 per cent in India. Additionally, pivotal drug studies, including bioequivalence testing for generic drugs, are increasingly being conducted outside the United States, which the agency states contributes to a weakened domestic pharmaceutical research and development infrastructure.

“Ensuring that Americans have access to high-quality, safe and effective generic medicines is critical to public health. Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,” said Dr. George Tidmarsh, M.D., Ph.D., Director of FDA’s Center for Drug Evaluation and Research. “It also slows down 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 prioritisation program can help ensure that Americans have a strong and resilient domestic drug supply, and also reflects the Trump Administration’s unwavering commitment to revitalising American industry and providing American consumers affordable access to needed medications.”

Earlier this week, the FDA hosted a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products.” The meeting focused on the FDA’s PreCheck program, which introduces a two-phase approach to accelerate the establishment of high priority pharmaceutical manufacturing facilities in the U.S. and enhance the domestic pharmaceutical supply chain. During the meeting, stakeholders discussed how incentives such as faster reviews could drive more investment into U.S.-based manufacturing and research and development.

The newly introduced ANDA prioritisation pilot is the latest step the FDA is taking to encourage domestic generic drug manufacturing and testing. Under this pilot program, ANDA applicants who conduct any required bioequivalence testing within the United States and manufacture their products domestically using exclusively U.S.-sourced APIs are eligible for priority review.

Applicants may request priority review by following the guidelines outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3, titled “Prioritisation of the Review of Original ANDAs, Amendments, and Supplements” and referencing this pilot program as the basis for prioritisation. Applicants must submit documentation demonstrating that their application qualifies, including confirmation that either the pivotal bioequivalence testing was conducted in the U.S. or that a waiver applies, that the finished dosage form manufacturer is U.S.-based, and that the API supplier is located in the U.S.

The FDA states that prioritising this additional category of ANDAs is expected to expedite the availability of U.S.-made generic drugs for American consumers.