The U.S. Food and Drug Administration (FDA) has introduced a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs).
The program is planned to support investment in U.S.-based drug discovery platform as well as research and development, and to promote the domestic pharmaceutical supply chain by offering faster reviews to generic drug companies that conduct testing and manufacturing in the United States.
As per the FDA, more than half of pharmaceuticals distributed in the U.S. are manufactured overseas. As of 2025, only 9 % 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.
Major drug studies, including bioequivalence testing for generic drugs, are increasingly being conducted outside the United States, which the agency states contribute to a weakened domestic pharmaceutical research and development infrastructure.
The newly introduced ANDA prioritization pilot is the latest step the FDA is taking to encourage domestic generic drug manufacturing and testing.
Executive Statement
According to Dr. George Tidmarsh, M.D., Ph.D., Director of FDA’s Center for Drug Evaluation and Research, 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. 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 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.
