In brief
The US Department of Commerce (“Commerce“) has initiated a Section 232 national security investigation into the imports of pharmaceuticals and pharmaceutical ingredients. This investigation aims to determine whether these imports threaten US national security. The scope of the investigation includes finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients (APIs), key starting materials, and derivative products of these items. Commerce may restrict imports of these products through tariffs, quotas, or other means if Commerce makes an affirmative finding.
Key points:
- Initiation Date: The investigation was initiated on April 1, 2025.
- Public Comments: Commerce has invited parties to submit public comments on this matter. The deadline for submitting comments is May 7, 2025. These comments are to address several supply and demand factors of such products, including (but not limited to) current US demand, domestic supply and its ability to serve domestic demand, the effect of other countries’ trade practices on prices, the ability to increase domestic production capacity, and the overall make-up for foreign supply chains and imports into the US market.
- Scope of Investigation: The investigation covers a broad range of pharmaceutical products and ingredients, including both generic and non-generic finished drug products, medical countermeasures, APIs, key starting materials, and derivative products.
Key deadlines:
- Commerce Report: Commerce must issue a report to the President with its findings no later than December 29, 2025. The report will include recommendations on potential actions the President may take to address national security issues identified by Commerce.
- Presidential Action: The President must announce any actions to be taken in response to Commerce’s findings no later than March 30, 2026.
Implications
This investigation could lead to significant changes in the importation of pharmaceuticals and pharmaceutical ingredients, potentially resulting in tariffs or other trade measures. Companies involved in the pharmaceutical supply chain, particularly those importing from foreign countries, should closely monitor the developments of this investigation and consider submitting comments to Commerce. Companies should also consider engaging in other informal methods such as partnering with US companies who are customers or partners that may have aligned interests and who may be granted audiences with Commerce leadership, other Executive branch leadership, and members of Congress.
The Baker McKenzie team would be happy to work with you on developing a strategy to navigate this investigation.
