Novo Nordisk ends Hims & Hers partnership over GLP-1 safety concerns

Compliance concerns over compounded semaglutide

The partnership dissolution stems from disagreements over distributing and marketing semaglutide products. Novo Nordisk claims that Hims & Hers engaged in "deceptive promotion and selling of illegitimate, knockoff versions of Wegovy" and failed to comply with regulations regarding compounded drugs.

"Novo Nordisk is firm on our position and protecting patients living with obesity," Dave Moore, Executive Vice President, U.S. Operations of Novo Nordisk Inc., said in the press release. "When patients are prescribed semaglutide treatments by their licensed healthcare professional or a telehealth provider, they are entitled to receive authentic, FDA-approved and regulated Wegovy."

The pharmaceutical company stated, "Hims & Hers Health, Inc. has failed to adhere to the law, which prohibits mass sales of compounded drugs under the false guise of 'personalization' and is disseminating deceptive marketing that puts patient safety at risk."

Supply chain integrity

The announcement raises broader concerns about pharmaceutical supply chains and the growing market for compounded versions of GLP-1 medications that are not FDA-approved.

Novo Nordisk's investigation claims that active pharmaceutical ingredients in certain compounded semaglutide products originate from Chinese manufacturers without FDA authorization or oversight.

According to Novo Nordisk, a Brookings Institute report found that "the FDA has never authorized or approved the manufacturing processes used by any of these foreign suppliers to make semaglutide, nor has the FDA ever reviewed or authorized the quality of the 'semaglutide' they produce."

The report also noted that many of these overseas suppliers "were never inspected by the FDA, and many of those that were [inspected] had drug quality assurance violations."

Moore indicated that Novo Nordisk will continue providing Wegovy through NovoCare Pharmacy to other telehealth organizations.

"We will work with telehealth companies to provide direct access to Wegovy that share our commitment to patient safety, and when companies engage in illegal sham compounding that jeopardizes the health of Americans, we will continue to take action," he said.

This breakup occurs amid ongoing discussions about balancing access with quality and cost control for high-demand GLP-1 medications used for weight management and cardiovascular risk reduction.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.