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Enforcement Actions Marketing Healthcare

Sheppard Mullin Richter & Hampton LLP

Inside the Ninth Circuit’s Interpretation of EKRA: Clarity for Kickback Law

On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...more

Buchalter

9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

Buchalter on

The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

BakerHostetler on

In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...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

Cozen O'Connor

Connecticut Loses It with Companies Selling “Research Grade” GLP-1 Drugs

Cozen O'Connor on

Connecticut AG William Tong announced enforcement actions against companies that allegedly advertised, distributed, or sold so-called “research grade” versions of GLP-1 weight loss drugs in violation of state consumer...more

Troutman Pepper Locke

Arizona AG Takes Action Against Company for Alleged Deceptive Marketing Practices

Troutman Pepper Locke on

Last month, Arizona Attorney General (AG) Kris Mayes announced a lawsuit alleging that CBR Systems, Inc. (CBR), one of the nation’s largest cord blood banking companies, engaged in deceptive and unfair practices....more

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 6

Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more

Troutman Pepper Locke

2024 State AG Year in Review

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State attorneys general (AGs) continue to play a pivotal role as innovators, shaping the regulatory environment by leveraging their expertise and resources to influence policy and practice. The public-facing nature of AG...more

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 3

FTC's Final Junk Fees Rule Narrowed in Scope - On December 17, 2024, the Federal Trade Commission (FTC) released its final Rule on Unfair or Deceptive Fees, commonly known as the "Junk Fees Rule." This final rule has a...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

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On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

Gardner Law

Back on the Case: FDA Issues Fresh Enforcement Letters

Gardner Law on

After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more

Arnall Golden Gregory LLP

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

Arnall Golden Gregory LLP

Out of Touch: FDA Takes Exception With Drug Company’s Promotion for Topical Drug Product

Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

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