News & Analysis as of

Customs and Border Protection Pharmaceutical Industry

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

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Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

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Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

Arnall Golden Gregory LLP

There Is Never a Bad Time To Audit Your Supply Chain

In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor....more

Polsinelli

COVID-19 Challenges Medical Equipment Supply Chains

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The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more

Hogan Lovells

FEMA releases exceptions to rule prohibiting exports of PPE – exports to Canada and Mexico are excluded and other important...

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On 17 April the Federal Emergency Management Agency (FEMA) released significant exceptions (effective Friday 17 April, but to be published on 21 April) to FEMA's temporary final rule prohibiting exports of certain personal...more

Cozen O'Connor

FEMA Issues Further Guidance on PPE Exports

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In an Alert published on April 10, we discussed temporary restrictions that the Federal Emergency Management Agency (FEMA) had placed on the export from the United States of certain personal protective equipment (PPE). ...more

Polsinelli

FEMA Issues Restrictions on PPE Exports Due to COVID-19 Pandemic

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On April 10, 2020, the U.S. Federal Emergency Management Agency (FEMA) published a Temporary Final Rule as part of its response to the COVID-19 pandemic.  The Temporary Final Rule allocates certain scarce or threatened...more

Akin Gump Strauss Hauer & Feld LLP

CBP Authorized to Detain Certain Exports of Health and Medical Materials Pursuant to FEMA Temporary Rule

- Beginning April 7, 2020, CBP is authorized to temporarily detain all shipments of five categories of personal protective equipment used in the response to and treatment of COVID-19, pursuant to a Temporary Rule issued by...more

ArentFox Schiff

FEMA Temporarily Halts Exports of Certain PPE

ArentFox Schiff on

The Federal Emergency Management Agency (FEMA) has exercised its delegated authority under the Defense Production Act (DPA) to issue a temporary final rule (Prioritization and Allocation of Certain Scarce or Threatened Health...more

Gibney Anthony & Flaherty, LLP

Online Safety: Avoiding Counterfeit COVID-19 Testing Kits

Almost as if on cue, as the United States ramps up testing and containment measures, US Customs and Border Protection (CBP) announced its first seizure of counterfeit COVID-19 test kits at the Los Angeles Airport...more

Perkins Coie

Federal Circuit Decides Country of Origin Test for Drugs Under Trade Agreements Act

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What is a thing? On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit gave us a new answer to this old philosophical question. In the case of pharmaceuticals, the U.S. Department of Veterans Affairs (VA)...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

Selling drugs to the Government just got a lot simpler. In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured,...more

Sheppard Mullin Richter & Hampton LLP

What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to...more

Morgan Lewis

Important Clarifications in the Federal Circuit Acetris Decision

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In addition to standing behind the plain language of the definition of a “US-made end product,” the court in Acetris Health, LLC v. United States provided new guidance regarding limits on Customs and Border Protection...more

Pillsbury Winthrop Shaw Pittman LLP

Substantial Transformation of the FAR Trade Agreements Clause

The Court found the disqualification of an offeror from a pharmaceutical procurement was in error based on a U.S. Customs and Boarder Protection (CBP) interpretation of the Trade Agreements Act of 1979 (TAA)....more

Faegre Drinker Biddle & Reath LLP

Appellate Court Rules that the Government May Procure U.S. Manufactured Drug Products Despite Use of Foreign Active Pharmaceutical...

On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision clarifying the interpretation of the Trade Agreements Act (TAA) and the Federal Acquisition Regulations (FAR) with respect to...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals

The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active...more

Blank Rome LLP

Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade...

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Earlier today, the United States Court of Appeals for the Federal Circuit issued a decision that is sure to send shockwaves through the generic drug industry....more

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

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When thinking of counterfeit products, minds may wander to a person on the street selling near-authentic looking bags, sunglasses, and watches, for a fraction of the price of what would be paid at a store. But what if there...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Mintz - Health Care Viewpoints

Medical Products & FDA: What to Watch for in 2019

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more

King & Spalding

U.S. Customs And Border Protection Announces Three New Members Of Commercial Targeting And Analysis Center

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Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more

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