Trump administration reveals Section 232 trade investigations into pharmaceuticals

On 16 April 2025, the U.S. Department of Commerce launched an investigation under Section 232 of the Trade Expansion Act, examining the national security implications of importing pharmaceuticals and pharmaceutical ingredients.

There is a public consultation process open for comments from interested parties until 7 May, after which time it is expected that an announcement of additional tariffs on pharmaceuticals will be made by the US Department of Commerce. Companies wishing to submit comments must do so by this date, the details of how they can do this are listed below. The EY Global Trade team can provide assistance here.

Background:

The scope of this inquiry covers the import profiling of a wide array of products, including finished drugs, active pharmaceutical ingredients, and key starting materials. The investigation aims to evaluate critical factors affecting the domestic pharmaceutical supply chain, including projected demand for pharmaceuticals, the capacity of U.S. production to meet that demand, and reliance on foreign supply chains.

The Department has provided a 21-day window during which public comments, data, and analyses from interested U.S. parties may be submitted to inform its assessment, particularly regarding the potential national security risks associated with current import practices. Public comments are invited until 7 May 2025, which will influence potential policy adjustments aimed at safeguarding national security and enhancing domestic production capabilities. Previous investigations typically have taken six to nine months to conclude, however indications from the Trump administration suggest that this review timeline will be expedited, given the current global trade landscape.

The following are the suggested proactive steps open to companies to influence the consultation process:

• Submit public comments: Prepare and submit detailed written comments to the Bureau of Industry and Security (BIS) by the specified deadline, addressing the investigation's criteria.
• Provide data and analyses: Include relevant data, analyses, and case studies that support positions, highlighting the state of the domestic pharmaceutical market and production capabilities.
• Engage in collaborative efforts: Collaborate with industry associations or coalitions to present a unified voice, amplifying concerns and recommendations through joint submissions.
• Participate in public hearings: Actively participate in any public hearings held as part of the investigation to present views directly to decision-makers and engage with other stakeholders.
• Highlight national security concerns: Emphasize how operations contribute to national security, including the importance of a robust domestic supply chain and risks of over-reliance on imports.
• Communicate with government officials: Engage with relevant government officials and policymakers through meetings, letters, or participation in industry events to convey perspectives and concerns.
• Monitor the process: Stay informed about the investigation's progress and developments in the consultation process to respond quickly to new opportunities for input or changes in the timeline.

This investigation could lead to significant changes in the pharmaceutical import landscape, impacting both domestic producers and foreign suppliers. It is critical for businesses to consider the impact this investigation may have on supply chain, compliance costs and overall business operations. Performing an impact assessment will also allow businesses to proactively identify potential duty mitigation or strategies to defer duty for cash-flow purposes. The EY Global Trade and Trade Policy teams are on hand to assist.

Contacts

If you require further information, please call your regular contact in EY or contact any of the following:

• Graham Reid
• Deirdre Hogan
• Colin Doolin
• Tomas Echazu
• Lewis Murphy
• Cristian Falon