On April 1, 2025, it was announced that the Department of Commerce had initiated an investigation under Section 232 of the Trade Expansion Act of 1962 to determine the effects on the national security of pharmaceuticals and pharmaceutical ingredients and their derivative products. This includes both finished generic and non-generic drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients and key starting materials, and derivative products of those items. Commerce’s Bureau of Industry and Security (BIS) has recently issued a Federal Register notice announcing that interested parties may submit written comments, data or other information pertinent to these investigations. Comments are due no later than May 7, 2025.
BIS is particularly interested in comments addressing: (i) the current and projected demand for pharmaceuticals and pharmaceutical ingredients in the United States; (ii) the extent to which domestic production of pharmaceuticals and pharmaceutical ingredients can meet domestic demand; (iii) the role of foreign supply chains, particularly of major exporters, in meeting U.S. demand for pharmaceuticals and pharmaceutical ingredients; (iv) the concentration of U.S. imports of pharmaceuticals and pharmaceutical ingredients from a small number of suppliers and the associated risks; (v) the impact of foreign government subsidies and predatory trade practices on the competitiveness of the U.S. pharmaceuticals industry; (vi) the economic impact of artificially suppressed prices of pharmaceuticals and pharmaceutical ingredients due to foreign unfair trade practices and state-sponsored overproduction; (vii) the potential for export restrictions by foreign nations, including the ability of foreign nations to weaponize their control over pharmaceuticals supplies; (viii) the feasibility of increasing domestic capacity for pharmaceuticals and pharmaceutical ingredients to reduce import reliance; (ix) 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; and (x) any other relevant factors.
Comments must be submitted at: www.regulations.gov. The Docket ID no. for this notice is BIS-2025-0022, and submitters must refer to XRIN 0694– XC120 in all comments.