Article Summary:
The U.S. Food and Drug Administration (FDA) is launching a new pilot program to prioritize the review of abbreviated new drug applications (ANDAs) for generic drugs that are manufactured and tested in the United States. This initiative aims to spur investment in U.S. drug manufacturing, research and development, and strengthen the domestic pharmaceutical supply chain.
The summary highlights that more than half of pharmaceuticals distributed in the U.S. are manufactured overseas, and the country is heavily reliant on foreign sources for active pharmaceutical ingredients (APIs). This overreliance on foreign drug manufacturing and testing creates risks to national security, patient access, and undermines investments in U.S. research, manufacturing, and production.
The pilot program offers faster reviews for generic companies that conduct their bioequivalence testing in the U.S. and manufacture their products using exclusively domestic API sources. This is expected to expedite the availability of high-quality, U.S.-made generic drugs for American consumers.
The FDA’s move reflects the Trump Administration’s commitment to revitalizing American industry and providing affordable access to needed medications. It also comes after the FDA hosted a public meeting to discuss incentives, such as faster reviews, to spur additional investment in U.S. pharmaceutical manufacturing and research and development.