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Department of Justice (DOJ) Manufacturers

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Morrison & Foerster LLP

CPSC Issues Weekly Record Level of Product Safety Notices

As noted in our recent client alert, the U.S. Consumer Product Safety Commission (CPSC) continues to aggressively pursue enforcement actions for violations of the Consumer Product Safety Act (CPSA) against foreign...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Environmental Criminal Enforcement/Clean Air Act: Erie, Pennsylvania Coke Manufacturing Plant Owner Guilty Plea

The United States Attorney’s Office, Western District of Pennsylvania issued a June 20th news release stating that Erie Coke Corporation (“ECC”) has pleaded guilty in federal court to two counts related to alleged criminal...more

Foley & Lardner LLP

Customs Fraud Makes the Big Leagues: DOJ’s New White-Collar Priorities Confirm Heightened Risk

Foley & Lardner LLP on

Last month, the Department of Justice put trade, customs, and tariff fraud squarely in the spotlight. This isn’t just another line item on the compliance checklist, it’s a loud-and-clear signal that import-related enforcement...more

Morrison & Foerster LLP

Proactivity in Product Safety: Best Practices for Compliance

Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more

Kelley Drye & Warren LLP

DOJ Intervenes in Customs False Claims Act Case, Consistent with Administration’s Focus on Foreign Trade

The United States has intervened and filed a superseding complaint in a False Claims Act case originally filed by a whistleblower in the Eastern District of California. The Government’s complaint alleges that an importer and...more

Oberheiden P.C.

10 Critical Facts for Defense Logistics Agency (DLA) Contractors Facing Suspension or Debarment

Oberheiden P.C. on

The Defense Logistics Agency (DLA), is cracking down on procurement fraud and contract fraud. It has recently issued multiple referrals for suspension or debarment, and it is targeting not only prime vendors, but...more

Hogan Lovells

Why medical device companies must prioritize compliance with DOJ's Data Security Program

Hogan Lovells on

This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

Morgan Lewis on

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges of the ENDS Industry: Part I

In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2025

Husch Blackwell LLP on

Intensifying international crises, increasing regulatory burdens, and uncertain macroeconomic conditions have led to an era of caution for manufacturers, but hidden among those challenges are exciting opportunities for...more

Thomas Fox - Compliance Evangelist

The Boeing Monitorship: Memo to Attorney General Garland and Kelly Ortberg

Gentlemen - I have written blog posts and articles about the proposed Plea Agreement negotiated between Boeing and the Department of Justice (DOJ). As the leaders of both organizations, I wanted to address you both...more

Thomas Fox - Compliance Evangelist

Boeing: Accept the Omnibus Monitor Approach

I recently wrote a series of blog posts and articles on why the Department of Justice (DOJ) should think big and go big with a completely new approach to the monitorship for Boeing under its agreement to take a guilty plea....more

Foley & Lardner LLP

DOJ to Ramp up Antitrust Enforcement in Agriculture Sector

Foley & Lardner LLP on

On June 21, 2024, Deputy Assistant Attorney General Michael Kades announced the Department of Justice (DOJ) Antitrust Division’s plan to increase both civil and criminal antitrust enforcement in the agriculture sector. As...more

Troutman Pepper Locke

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

Troutman Pepper Locke on

In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Thomas Fox - Compliance Evangelist

To the DOJ: Think Big and Go Big on the Boeing Monitorship

Perhaps the most significant blog post in the compliance arena was penned by Matt Ellis over 10 years ago when he challenged Walmart to “Go Big” on compliance. (They did.) We are now at another inflection point in compliance...more

Fisher Phillips

Snapshot on Manufacturing Industry: New Program Encouraging Corporate Whistleblowing Puts Manufacturers on Notice

Fisher Phillips on

Welcome to this edition of the FP Snapshot on the Manufacturing Industry, where we take a quick snapshot look at a recent significant workplace law development with an emphasis on how it impacts employers in the manufacturing...more

Adams & Reese

International Compliance Digest – May 2024

Adams & Reese on

May saw the long-awaited release of the USTR’s Section 301 review. USTR confirmed that the Trump-era tariffs will remain in place, and raised those tariffs by another $18 billion on manufacturing, critical minerals, solar...more

ArentFox Schiff

Is the Robinson-Patman Act Returning? Or Was It Never Really Gone?

ArentFox Schiff on

The Federal Trade Commission (FTC) has heralded its increased antitrust scrutiny of price discrimination under the Robinson-Patman Act (RPA), though little has come of it to date. Yet, our review of trends in private...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Fox Rothschild LLP

New Comment on Right to Repair Products

Fox Rothschild LLP on

This week, the Federal Trade Commission (FTC) and Department of Justice (DOJ) submitted a comment to the U.S. Copyright Office to advocate for renewed and expanded exemptions to the Digital Millenium Copyright Act (DCMA),...more

Maynard Nexsen

Recent FCA Settlement Highlights Small Business Certification Issues in Private Equity Transactions

Maynard Nexsen on

The Department of Justice ("DOJ") recently announced a $1.75 million false claims settlement with a contractor that "improperly obtained government contracts that were set-aside for small businesses." The DOJ settlement...more

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