Lanton Law Talks to Applied Clinical Trials About How FDA Cuts Are Creating New Bottlenecks in Clinical Operations

In Part 2 of the interview; Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines. The interview can be seen here.

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.   

President Biden Invokes Defense Production Act to Help Issues Related to EV Battery Materials

President Biden has invoked the Defense Production Act as a means to increase mineral production that is used to manufacture electric vehicle batteries. The document titled “Memorandum on Presidential Determination Pursuant to Section 303 of the Defense Production Act of 1950” seen here, seeks to:

“To promote the national defense, the United States must secure a reliable and sustainable supply of such strategic and critical materials.  The United States shall, to the extent consistent with the promotion of the national defense, secure the supply of such materials through environmentally responsible domestic mining and processing; recycling and reuse; and recovery from unconventional and secondary sources, such as mine waste.” 

As the world transitions to clean energy, the minerals targeted by this Order will be lithium, nickel, cobalt, graphite, and manganese for large capacity batteries. 

The transition to clean energy is being felt now. With soaring energy prices due to the war in Ukraine we foresee plenty of change happening with supply chain security. 

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. We help stakeholders understand what’s at issue so that we can help our valued clients achieve their priorities. Contact us to learn about how either our legal or lobbying services can help you attain your goals.