News & Analysis as of

National Security Supply Chain Pharmaceutical Industry

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Benesch

Sectoral Tariff Update - Section 232 National Security Investigations

Benesch on

Sectoral tariffs are emerging as a preferred tool for the White House that leaves targeted industries, and those reliant on their import supply, subject to appreciably higher customs duties on imported goods. A wide range of...more

Braumiller Law Group, PLLC

Hot Topics in International Trade - June 2025 - Trump’s Plan B for Tariffs

On May 28, 2025, the United States’ Court of International Trade (CIT) struck down the President’s use of the International Economic Emergency Powers Act (IEEPA) to impose tariffs. This includes tariffs imposed on Canada,...more

Polsinelli

Trump Administration Announces New Executive Order to Promote Domestic Production of Biopharmaceuticals

Polsinelli on

Key Takeaways - Regulatory Relief for U.S. Manufacturing: The EO streamlines FDA and EPA processes to encourage domestic pharmaceutical production....more

Eversheds Sutherland (US) LLP

A Closer Look at the UK – US Economic Prosperity Deal - Tariffs, National Security and Beyond

The new US-UK Economic Prosperity Deal (“EPD”), announced last week (8 May 2025), is promising to bring back economic stability and will be welcomed by businesses at a time of increased geopolitical uncertainty....more

Sheppard Mullin Richter & Hampton LLP

Onshoring Pharma Ops: Reading Recent EO and Policy Tea Leaves

Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening oversight of...more

King & Spalding

New Executive Order Promotes Domestic Production of Critical Medicines

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On May 5, 2025, President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of Critical Medicines. The EO directs the U.S. Food and Drug Administration (“FDA”), U.S....more

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

Morgan Lewis on

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more

Hogan Lovells

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

Hogan Lovells on

On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more

Pillsbury Winthrop Shaw Pittman LLP

President Trump Initiates Section 232 Investigations into Pharmaceuticals, Semiconductors, Critical Minerals and Trucks

The Trump administration has intensified its America First Trade Policy initiatives by announcing three new investigations under Section 232 of the Trade Expansion Act of 1962 by the Department of Commerce. As foreshadowed in...more

Morgan Lewis - As Prescribed

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more

Orrick, Herrington & Sutcliffe LLP

Tariffs Loom for Imports of Semiconductor and Pharmaceutical Products and Critical Minerals as Trump Administration Initiates...

The Trump administration is pursuing additional national security investigations that will likely lead to tariffs on imports of semiconductors, semiconductor manufacturing equipment (“SME”), and derivative articles,...more

ArentFox Schiff

232 Investigation of Pharmaceuticals: Potential Tariffs and Tight Comment Deadline

ArentFox Schiff on

Effective April 5, the United States imposed a 10% baseline tariff on imports from nearly all countries, excluding products from Canada and Mexico, and those products contained in the Harmonized Tariff Schedule of the United...more

Baker Donelson

New Section 232 Investigations Target Pharmaceutical, Semiconductor, and Critical Mineral Industries: What Impacted Businesses...

Baker Donelson on

The Department of Commerce (Commerce) has launched three Section 232 investigations covering pharmaceuticals, pharmaceutical ingredients, and their derivative products; semiconductors and semiconductor manufacturing equipment...more

Foley Hoag LLP

U.S. Department of Commerce Investigates Possible Tariffs on Pharmaceuticals: Forecasting the Impact and an Opportunity to Comment

Foley Hoag LLP on

I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more

Torres Trade Law, PLLC

Semiconductor Tariff Exclusions & New Section 232 Investigations

Torres Trade Law, PLLC on

This article provides an overview of the most recent tariff updates affecting businesses operating within the semiconductor, pharmaceutical, and critical mineral industries. Below we outline recent tariff exclusions for...more

Brownstein Hyatt Farber Schreck

Trump Administration Takes First Steps Towards Tariffs on Pharmaceuticals

After months of signaling, the Department of Commerce disclosed on April 14 that it had begun an investigation into the national security impacts of importing pharmaceuticals, pharmaceutical ingredients and derivative...more

DLA Piper

Department of Commerce Announces Section 232 Pharmaceutical Investigation

DLA Piper on

The Trump Administration issued a notice on Monday titled, “Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients,” which could serve...more

Alston & Bird

Commerce Seeks Comments on Section 232 Pharmaceutical Investigation

Alston & Bird on

Yesterday, April 16, 2025, the Bureau of Industry and Security (BIS), a bureau within the U.S. Department of Commerce, published a “Notice of Request for Public Comments on Section 232 National Security Investigation of...more

Holland & Knight LLP

Trump Administration Initiates Section 232 Investigation into Pharmaceuticals

Holland & Knight LLP on

The U.S. Department of Commerce announced that it has initiated a Trade Expansion Act of 1962 Section 232 investigation to determine whether imports of pharmaceutical products and ingredients pose a national security risk to...more

White & Case LLP

Trump Administration Initiates Section 232 Investigations on Pharmaceuticals and Semiconductors

White & Case LLP on

On April 14, 2025, the US Department of Commerce Bureau of Industry and Security (BIS) announced the initiation of investigations into the effects on US national security of imports of pharmaceuticals and pharmaceutical...more

Polsinelli

New Section 232 Trade Investigations on Pharmaceutical and Semiconductor Imports Could Lead to Tariffs Mid-Year

Polsinelli on

On April 1, 2025, the Secretary of Commerce initiated, pursuant to President Trump’s directive, two new investigations under Section 232 of the Trade Expansion Act of 1962 (Section 232), one on imports of pharmaceuticals and...more

Wiley Rein LLP

Commerce Seeks Comment in New National Security Investigations Covering Pharmaceutical and Semiconductor Imports

Wiley Rein LLP on

On April 14, 2025, the U.S. Department of Commerce (Commerce) released draft Federal Register notices soliciting public comments in two previously unannounced investigations into the national security impacts of imported...more

Husch Blackwell LLP

Trump Administration Initiates New Section 232 Probe on Pharmaceuticals and Semiconductors

Husch Blackwell LLP on

On April 14, 2025, the Trump Administration issued two federal register notices scheduled to be published on April 16, 2025. The notices seek public comments following the April 1, 2025 initiation of investigations targeting...more

Foley & Lardner LLP

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

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In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more

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