National Security Investigation Into Imports Of Pharmaceuticals And Ingredients

On April 16, 2025, the U.S. Department of Commerce's Bureau of Industries and Security (BIS) issued a notice that it is investigating the threat imports of pharmaceuticals and pharmaceutical ingredients pose to U.S. national security.¹ This investigation could lead to the imposition of tariffs on covered pharmaceuticals and pharmaceutical ingredients similar to the 25% section 232 tariffs that became effective on March 12, 2025 on steel articles, aluminum articles, and their derivatives.

The investigation covers "imports 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."² This is a broad range of imports and inputs, many of which are not currently produced in significant quantities in the United States, if at all. As such, this investigation could have widespread impact across the entire pharmaceutical industry as well as life sciences and healthcare sectors.

Generally, national security investigations conducted under section 232 of the Trade Expansion Act require the Commerce Department to reach its determination within 270 days.³ At the conclusion of the investigation Commerce will report its findings to the President on whether imports of pharmaceutical and pharmaceutical ingredients into the United States threaten national security. Previous investigations' reports have also provided recommendations on actions to mitigate such threats, including potential tariffs, export controls, or incentives to increase domestic production; and policy recommendations for strengthening the United States' domestic and friend-shored supply chain through strategic partnerships, industrial incentives or investments, and regulatory reforms.

Notably, for most of the factors Commerce will be investigating, the U.S. industry is best situated to provide information on the U.S. domestic industry's macro- and micro-economic conditions, as well as challenges experienced during the course of business. Significantly, as with Commerce's past Section 232 investigations on steel, aluminum, and automobiles and automotive parts, Commerce has now invited interested parties to comment and participate in public hearings.⁴ Parties will have until May 7, 2025 to submit comments which may be public or confidential.⁵ Accordingly, for companies that may be affected by this investigation, it is important to understand the issues early and develop a strategy to best serve your interests.

Buchanan has a team of international trade and national security attorneys, life sciences and regulatory attorneys, economists, accounting analysts, and government relations professionals ready to help U.S. manufacturers with U.S. law at the intersection of trade and life sciences, as well as related policy. Our dedicated team has decades of experience supporting clients across a range of industries – ranging from chemicals, agricultural products, synthetics, minerals, medical equipment – to protect U.S. companies against unfair trade.

Footnotes

1 Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients, 90 Fed. Reg. 15,951 (Apr. 16, 2025) (Notice).

2 Id.

3 19 U.S.C. § 1862.

4 See generally Notice.

5 Id.

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