Section 232 Targets Drug Imports: What It Means for Pharma and Healthcare

​On April 1, 2025, the U.S. Department of Commerce initiated a Section 232 national security investigation into the importation of pharmaceuticals and pharmaceutical ingredients. This inquiry aims to assess whether the reliance on foreign sources for essential medical products poses a threat to national security. The scope includes finished drug products, active pharmaceutical ingredients (APIs), key starting materials, and related derivatives.​

The Department of Commerce is soliciting public comments to inform this investigation. Stakeholders are encouraged to provide input on various factors, including:​

• The current and projected demand for pharmaceuticals and their ingredients in the U.S.​

• The capacity of domestic production to meet this demand.​

• The role and risks associated with foreign supply chains.​

• The impact of foreign government subsidies and trade practices on U.S. industry competitiveness.​

• The feasibility of expanding domestic manufacturing to reduce import reliance.​

Comments must be submitted by May 7, 2025, through the Federal Rulemaking Portal at www.regulations.gov, referencing Docket ID BIS-2025-0022. Submissions containing business confidential information should be clearly marked and accompanied by a non-confidential version.​

For further details, please refer to the official notice in the Federal Register: Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients.​

There are plenty of questions and speculation about what this means for specific supply chain participants. Contact Lanton Strategies to learn about how we can help you respond to these comments as well as help you speak with either Congress or the Administration to get your voice heard.   

New Request for Public Comment Regarding Technology Stakeholders

The Bureau of Industry and Security, Office of Technology Evaluation, U.S. Department of Commerce has issued a Notice of request for public comment. The notice is titled Notice of Request for Public Comments. According to the Bureau: 

On February 24, 2021, President Biden issued Executive Order 14017 (E.O. 14017) on “America's Supply Chains,” which directs several federal agency actions to secure and strengthen America's supply chains. One of these directions is for the Secretary of Commerce and the Secretary of Homeland Security, in consultation with the heads of appropriate agencies, to submit, within one year of the date of E.O. 14017, a report on supply chains for critical sectors and subsectors of the information and communications technology (ICT) industrial base (as determined by the Secretary of Commerce and the Secretary of Homeland Security), including the industrial base for the development of ICT software, data, and associated services. This notice requests comments and information from the public to assist the Secretary of Commerce and the Secretary of Homeland Security in preparing the report required by E.O. 14017.

The comment deadline is November 4, 2021. 

Lanton Law’s technology practice has been monitoring similar legislative and legal developments. If you are a technology or healthcare/life science stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.