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.

Photo of Scott E. Diamond** Scott E. Diamond**

Scott is a senior policy advisor with more than 25 years’ experience with the legislative and regulatory processes involved in international trade policy, remedies and enforcement. This includes working with clients on matters involving export controls, economic sanctions, human rights and forced labor…

Scott is a senior policy advisor with more than 25 years’ experience with the legislative and regulatory processes involved in international trade policy, remedies and enforcement. This includes working with clients on matters involving export controls, economic sanctions, human rights and forced labor compliance, corporate anti-boycott and antibribery compliance, national security investigations, and foreign direct investment in the United States.

Photo of David M. Schwartz David M. Schwartz

David is the leader of Thompson Hine’s International Trade practice group and a member of the firm’s International Committee. He advises clients on the risks and opportunities presented by U.S. international trade laws and regulations and international trade agreements. He focuses on antidumping…

David is the leader of Thompson Hine’s International Trade practice group and a member of the firm’s International Committee. He advises clients on the risks and opportunities presented by U.S. international trade laws and regulations and international trade agreements. He focuses on antidumping (AD), countervailing duty (CVD) and safeguard litigation, international trade policy, and cross-border compliance issues affecting goods, services, technology and investments that involve transportation, customs, export controls, economic sanctions, anti-boycott and anti-bribery laws and regulations.

Photo of Samir D. Varma Samir D. Varma

Samir advises multinational corporations on export controls, economic sanctions and customs, and counsels individuals and corporations on the Foreign Corrupt Practices Act (FCPA) and other anti-corruption laws. He represents clients in enforcement actions before U.S. regulatory agencies and conducts corporate internal investigations.

Photo of Francesca M.S. Guerrero Francesca M.S. Guerrero

Francesca counsels clients on compliance with export controls, sanctions, import regulations, human rights and forced labor, and the FCPA and antibribery laws. She works closely with companies to develop tailored compliance programs that fit their specific needs, and routinely advises clients on some…

Francesca counsels clients on compliance with export controls, sanctions, import regulations, human rights and forced labor, and the FCPA and antibribery laws. She works closely with companies to develop tailored compliance programs that fit their specific needs, and routinely advises clients on some of their most challenging international transactions, involving dealings in high-risk jurisdictions or with high-risk counterparties. Francesca also counsels companies through all phases of internal investigations of potential trade and antibribery violations and represents companies across industries before related government agencies.

Photo of Aaron C. Mandelbaum Aaron C. Mandelbaum

Aaron focuses his practice on advising clients on compliance with international economic sanctions, export controls, and U.S. import laws and regulations. He is also involved in assisting clients with complex cross-border transactions, anti-dumping and countervailing duty litigation, utilization of international and preferential trade…

Aaron focuses his practice on advising clients on compliance with international economic sanctions, export controls, and U.S. import laws and regulations. He is also involved in assisting clients with complex cross-border transactions, anti-dumping and countervailing duty litigation, utilization of international and preferential trade agreements, and customs classifications. Most recently, Aaron has counseled clients navigating requirements under the Export Administration Regulations.