The U.S. Department of Commerce (DOC), Bureau of Industry and Security, Office of Strategic Industries and Economic Security has released a Request for Information (RFI) on “the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients.” The DOC investigation began on April 1, 2025, and was initiated under section 232 of the Trade Expansion Act of 1962. DOC seeks information on finished generic and non-generic pharmaceuticals, medical countermeasures, active pharmaceutical ingredients, and key starting materials.
DOC is particularly interested in comments on the following topics:
- “The current and projected demand for pharmaceuticals and pharmaceutical ingredients in the United States;
- The extent to which domestic production of pharmaceuticals and pharmaceutical ingredients can meet domestic demand;
- The role of foreign supply chains, particularly of major exporters, in meeting United States demand for pharmaceuticals and pharmaceutical ingredients;
- The concentration of United States imports of pharmaceuticals and pharmaceutical ingredients from a small number of suppliers and the associated risks;
- The impact of foreign government subsidies and predatory trade practices on United States pharmaceuticals industry competitiveness;
- The economic impact of artificially suppressed prices of pharmaceuticals and pharmaceutical ingredients due to foreign unfair trade practices and state-sponsored overproduction;
- The potential for export restrictions by foreign nations, including the ability of foreign nations to weaponize their control over pharmaceutical supplies;
- The feasibility of increasing domestic capacity for pharmaceuticals and pharmaceutical ingredients to reduce import reliance;
- The impact of current trade policies on domestic production of pharmaceuticals and pharmaceutical ingredients, and whether additional measures, including tariffs or quotas, are necessary to protect national security”
DOC seeks comments from any interested parties through written comments, data, and analyses.
Deadline: Comments may be submitted through the Federal rulemaking portal www.regulations.gov and must be submitted by May 7, 2025.
Sources and Additional Information:
- More information on the RFI is available at https://www.federalregister.gov/documents/2025/04/16/2025-06587/notice-of-request-for-public-comments-on-section-232-national-security-investigation-of-imports-of#h-8.
- Comments on the RFI can be submitted at https://www.regulations.gov/.