By Fineline Cube 
The U.S. Food and Drug Administration (FDA) announced the launch of “FDA PreCheck” on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.
Current Reliance on Foreign Manufacturing
More than half of the pharmaceuticals distributed in the U.S. are currently manufactured overseas. The U.S. is also heavily reliant on foreign sources for active pharmaceutical ingredients (APIs). Only 11% of API manufacturers for FDA-approved products are based in the U.S.
FDA Commissioner’s Statement
According to FDA Commissioner Marty Makary, M.D., M.P.H., “Our gradual overreliance on foreign drug manufacturing has created national security risks.” He emphasized that the FDA PreCheck initiative is one of many steps the FDA is taking to reverse this reliance and ensure a resilient, strong, and domestic drug supply for Americans.
Executive Order and Program Details
FDA PreCheck was developed in response to Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines.” The order directs the FDA to streamline its review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements. The PreCheck program introduces an innovative two-phase approach to facilitate the establishment of new U.S. drug manufacturing facilities.-Fineline Info & Tech