Pharmaceuticals

The Federal Trade Commission (FTC), joined by the States of California and Utah, has filed a lawsuit against telehealth company Hims & Hers, alleging that the company engaged in deceptive privacy, billing, and subscription practices. According to the lawsuit, Hims & Hers shared consumers’ health information with third-party advertising companies, including Meta and Snap, despite…

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a favorable Advisory Opinion (No. 26-14) to a pharmaceutical manufacturer that is proposing to offer free antibody testing to patients.

In the proposed arrangement, the manufacturer would offer free antibody testing to determine whether patients would qualify for a prescribed…

The U.S. Food and Drug Administration (FDA) recently approved Eli Lilly and Company’s oral GLP-1 receptor agonist, Foundayo (orforglipron), for chronic weight management in adults with obesity or those who are overweight with at least one weight-related condition.

The approval introduces a new oral treatment option in a space that has been largely dominated by…

Medical spas continue to expand beyond traditional aesthetic services, and peptides have quickly become one of the more heavily marketed offerings in this space. While these products are often positioned as part of a broader “wellness” model, the legal framework that governs them is far less flexible.

At the federal level, the key issue is…

On April 1, the U.S. Food and Drug Administration (FDA) clarified its policies on compounded drugs, including compounded versions of GLP-1 products. Compounders are permitted to produce copies of approved drugs only while those drugs are listed in FDA’s ​shortage database.

GLP-1 products are used primarily for weight loss and diabetes. They include semaglutide (used…

On September 18, Rivkin Radler’s Jeff Kaiser will participate on a panel at Practising Law Institute’s Life Sciences 2025: Navigating Legal Challenges in Drug and Device Industries. Jeff’s panel is entitled “Enforcement Trends Impacting the Drug and Device Industries.”

Held at PLI’s NY Conference Center, located at 1177 Avenue of the Americas, the program will…

On July 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance priority enforcement areas” in combating healthcare fraud. The two agencies cited the long history of partnership between them in enforcing…

Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a Bristol Myers subsidiary that originally developed and marketed the drug. Cigna alleges that Celgene violated U.S. antitrust laws by…

An article in the March 10 issue of Part B News, “In trend, court limits drug rebate AKS charges to easier ‘but-for’ standard,” discussed a recent ruling on the False Claims Act (FCA) implications of the federal Anti-Kickback Statute (AKS). Rivkin Radler’s Jeff Kaiser was quoted in the article.

“Every time a…