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Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

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FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

Loeb & Loeb LLP

In Our "Wellness Retreat" Era. But First, the Paperwork.

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These days, the explosive growth of the wellness industry—fueled by increased consumer interest in healthy lifestyle choices—presents a prime opportunity for brands to showcase their offerings through “wellness retreats” with...more

Epstein Becker & Green

New Seventh Circuit Decision Signals Greater Flexibility for Healthcare Marketing Services

Epstein Becker & Green on

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit issued a decision in a case involving the federal Anti-Kickback Statute (“AKS”) and marketing services that the court framed as an appeal...more

Troutman Pepper Locke

Arizona AG Takes Action Against Company for Alleged Deceptive Marketing Practices

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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

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...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

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

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Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Holland & Knight LLP

Novel Settlement Reached in Generative AI Deceptive Trade Practices Healthcare Investigation

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The state of Texas, by and through its Attorney General Ken Paxton, reached a first-of-its-kind settlement agreement with Pieces Technologies Inc. (Pieces) following an investigation into Pieces' alleged violations of the...more

Mintz - Health Care Viewpoints

The OIG Issues New FAQs on Financial Assistance Policies and Marketing to Patients

On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

Holland & Knight LLP

Lessons Learned from FTC Enforcement Action Against BetterHelp

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The Federal Trade Commission (FTC) is on a roll in its efforts to signal to the digital health industry that data privacy must be a priority. The FTC announced a consent decree with BetterHelp on March 2, 2023, to settle...more

Holland & Knight LLP

Podcast - How to Comply with FTC's Guidance for Healthcare Companies

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In the fourth episode of his "Clearly Conspicuous" podcast series, "How to Comply with FTC's Guidance for Healthcare Companies," consumer protection attorney Anthony DiResta takes a look at the Federal Trade Commission's...more

Foley & Lardner LLP

Compliance Issues in Hospital and Health System Sports Sponsorships

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Many hospital, health systems and other health care providers have seen benefits in sponsoring sports teams, stadiums and athletic tournaments. Considerations include general branding in the community, recruitment of staff or...more

Cozen O'Connor

1st Amendment Win For Credit Card Surcharges| Texas Sues Over Electricity Bills | Dodgy COVID Fees

Cozen O'Connor on

2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more

Patrick Malone & Associates P.C. | DC Injury...

Cracking down on medical hype could cut $30 billion in wasted costs

When reformers look for ways to slash the ever-higher costs of American medical care, one line item should leap from television screens, print pages, and radio broadcasts: How does the nation benefit from medical enterprises...more

Dickinson Wright

Healthcare Legal News Volume 5 Number 2

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According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

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