News & Analysis as of

Fraud Enforcement Actions Food and Drug Administration (FDA)

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
Cozen O'Connor

Weighty Penalty for Bootleg GLP-1 Drug Sales

Cozen O'Connor on

Connecticut AG William Tong announced a settlement with Triggered Brand following allegations that the company unlawfully advertised and sold counterfeit GLP-1 weight loss drugs in violation of state consumer protection laws....more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Troutman Pepper Locke

Connecticut AG Pursuing Companies for Allegedly Selling Unlawful Weight Loss Drugs

Troutman Pepper Locke on

Connecticut Attorney General (AG) William Tong has taken legal action against two online distributors, Triggered Brand and Made In China, for allegedly selling research-grade GLP-1 weight loss drugs directly to Connecticut...more

Arnall Golden Gregory LLP

What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Cooley LLP

Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases

Cooley LLP on

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more

Foley Hoag LLP

Health Care Fraud Enforcement in 2025

Foley Hoag LLP on

We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more

American Conference Institute (ACI)

[Event] 11th Legal, Regulatory & Compliance Forum on Dietary Supplements - June 28th - 29th, New York, NY

ACI and CRN are excited to welcome you back to New York City this Spring for the 11th Legal, Regulatory & Compliance Forum on Dietary Supplements. Since last year, there have been numerous important developments...more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more

Dorsey & Whitney LLP

DOJ Announces First Settlement Under New Civil Cyber-Fraud Initiative

Dorsey & Whitney LLP on

In October 2021, the Department of Justice (“DOJ”) announced its new Civil Cyber-Fraud Initiative, led by the Civil Division’s Fraud Section, to enhance its ongoing efforts to address cybersecurity threats. The initiative...more

MoFo Life Sciences

Key Takeaways From FDLI's Enforcement, Litigation, And Compliance Conference Keynote Address

MoFo Life Sciences on

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more

King & Spalding

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

King & Spalding on

As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more

Seyfarth Shaw LLP

Consumer Fraud Increases in the Wake of COVID-19 and Enforcement Activities Quickly Follow

Seyfarth Shaw LLP on

Last week, the Federal Trade Commission (“FTC”) and Food & Drug Administration (“FDA”) ramped up their enforcement letters since they first issued COVID-19 related warning letters a month ago. ...more

Mintz - ML Strategies

Tackling False Claims Being Made for COVID-19 Treatments and Products

Mintz - ML Strategies on

Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more

Morrison & Foerster LLP - Class Dismissed

FDA And FTC Send Warning Letters To Companies Marketing Products To Treat Coronavirus; State Attorneys General Follow Suit

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more

Rivkin Radler LLP

FTC and FDA Take Joint Action to Stop COVID-19 Fraud

Rivkin Radler LLP on

On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Cadwalader, Wickersham & Taft LLP

The Delaware Court of Chancery Rejects Termination of Merger Agreement Based on Material Adverse Effect

In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more

Sullivan & Worcester

Be Careful What You Say – Or Rather What You Don’t Say – AVEO Pays $4 Million to SEC to Settle Fraud Charges

Sullivan & Worcester on

In March 2016, the Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based biopharmaceutical company, agreed, without admitting or denying the allegations, to pay $4 million to...more

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