News Brief: FDA Launches Pilot Program to Boost U.S. Generic Drug Production

On October 3, 2025, The U.S. Food and Drug Administration (FDA) announced a pilot program to prioritize the review of abbreviated new drug applications (ANDAs) from generic drug companies that conduct both manufacturing and testing in the United States. The initiative aims to strengthen domestic drug production and secure the U.S. pharmaceutical supply chain.

Currently, over half of drugs distributed in the U.S. are manufactured abroad, with only 9% of active pharmaceutical ingredient (API) production occurring domestically. China and India account for 22% and 44% of global API manufacturing, respectively, and much bioequivalence testing is also done overseas.

George Tidmarsh, PhD, Director of the FDA’s Center for Drug Evaluation and Research, said, “Ensuring Americans have access to high-quality, safe, and effective generic medicines is critical to public health. Overreliance on foreign drug manufacturing creates risks to national security and patient access.”

The pilot program offers faster reviews for ANDAs from U.S.-based manufacturers, encouraging investment in domestic drug manufacturing and testing.