What's Happening?
The U.S. Food and Drug Administration (FDA) has announced the FDA PreCheck program aimed at bolstering the domestic pharmaceutical supply chain. This initiative seeks to increase regulatory predictability and facilitate the construction of drug manufacturing sites within the United States. Currently, over half of the pharmaceuticals distributed in the U.S. are manufactured overseas, with only 11% of active pharmaceutical ingredient (API) manufacturers located domestically. FDA Commissioner Marty Makary highlighted the national security risks posed by reliance on foreign drug manufacturing. The PreCheck program, developed in response to Executive Order 14293, introduces a two-phase approach to streamline the establishment of new U.S. drug manufacturing facilities. The Facility Readiness Phase involves frequent FDA communication during critical development stages, while the Application Submission Phase focuses on streamlining the Chemistry, Manufacturing, and Controls section of drug applications. A public meeting on the program is scheduled for September 30, 2025, at the FDA White Oak Campus in Silver Spring, Maryland.
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Why It's Important?
The FDA PreCheck program is significant as it addresses the national security risks associated with the U.S.'s dependence on foreign drug manufacturing. By promoting domestic production, the initiative aims to ensure a resilient and strong drug supply chain within the country. This move could potentially benefit U.S. pharmaceutical companies by reducing regulatory barriers and encouraging investment in domestic manufacturing facilities. It also aligns with broader efforts to enhance national security and economic independence. The program's success could lead to increased job creation and innovation in the pharmaceutical sector, while also ensuring a more reliable supply of critical medicines for American consumers.
What's Next?
The FDA will host a public meeting titled 'Onshoring Manufacturing of Drugs and Biological Products' on September 30, 2025, to discuss the FDA PreCheck draft framework. Stakeholders will have the opportunity to explore the strengths and opportunities of the framework and consider additional measures to overcome current onshoring challenges. The meeting will feature presentations and discussions, with virtual participation available. The outcomes of this meeting could influence the future direction of the PreCheck program and its implementation across the pharmaceutical industry.
