Your prescribed dose of health law news
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…
In a recent Advisory Opinion (No. 26-01), the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that waiving cost sharing for certain commercially insured patients who receive a cancer screening test is permissible under the federal Anti-Kickback Statute.
The opinion pertains to a clinical laboratory test that screens for…
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 September 19, Rivkin Radler’s Jeff Kaiser will participate on a panel at Practising Law Institute’s “Life Sciences 2024: Navigating Legal Challenges in Drug and Device Industries” program in New York City.
Held at PLI’s NY Conference Center at 1177 Avenue of the Americas and also available to view online, the program will cover the…
Marc S. Ullman, of counsel to Rivkin Radler, wrote the March 28 article “FDA sends a message with two warning letters to Amazon” in Natural Products Insider.
In the article, Marc explains the importance of the FDA warning letters on homeopathic “supplements” and products that contain active pharmaceutical ingredients. Marc writes, “During the…
A September 29 article in NutraIngredients-USA, “New Jersey Man Arrested for Selling Counterfeit Supplements on Amazon,” discussed the arrest of Brad Snyder of Marlton, NJ, for allegedly counterfeiting Pure Encapsulations and Nature M.D. branded products and selling them online. Rivkin Radler’s Steve Shapiro was quoted in the article.
Steve noted the seriousness…
On September 14, Rivkin Radler’s Jeff Kaiser will participate on a panel at Practising Law Institute’s Life Sciences 2023: Navigating Legal Challenges in Drug and Device Industries program in New York City.
Held at PLI’s New York Conference Center at 1177 Sixth Avenue, the program will cover the explosive growth of digital health and the…
On December 20, the Federal Trade Commission’s Bureau of Consumer Protection announced the issuance of Health Products Compliance Guidance. The revised Guidance updates the FTC’s 1998 guide, Dietary Supplements: An Advertising Guide For Industry, and is a must read for everyone involved in marketing, labeling, and creating and evaluating substantiation for dietary supplements and…
