The telehealth company Hims & Hers swiftly removed a low-cost, compounded version of the weight-loss drug Wegovy from its platform just two days after launch, following a sharp warning from the U.S. Food and Drug Administration (FDA) and an ensuing patent infringement lawsuit filed by Novo Nordisk, the original manufacturer. The move underscores growing tensions between efforts to expand access to expensive medications and the need to ensure patient safety and regulatory compliance.
FDA Intervention and Regulatory Concerns
Hims & Hers had advertised the compounded semaglutide pill as a cheaper alternative to Wegovy, priced at $49 per month. However, this sparked immediate criticism from medical specialists and regulators. Compounded drugs, unlike FDA-approved medications, do not undergo rigorous clinical trials to verify their safety, efficacy, or consistent quality control.
The FDA responded forcefully. Commissioner Martin A. Makary announced the agency’s intent to take “decisive steps” against mass-marketed, non-approved drugs mimicking FDA-approved GLP-1s. The Department of Justice was also alerted to potential violations of federal drug regulations.
“These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy,” Dr. Makary stated.
Novo Nordisk Lawsuit and the “Tipping Point”
Novo Nordisk escalated the conflict by filing a patent infringement lawsuit against Hims & Hers on February 9th, seeking to permanently ban sales of the compounded version and recover monetary damages. This marks the first time Novo Nordisk has pursued legal action against a compounding pharmacy in the U.S.
Novo Nordisk’s general counsel, John Kuckelman, described the Hims & Hers launch as a “tipping point” in the debate over compounding practices, arguing that the industry has reached a breaking point.
The Debate: Access vs. Safety
Hims & Hers defended its approach, framing the lawsuit as an attempt by “Big Pharma” to restrict consumer choice. The company claims that compounded medications provide necessary access for those priced out of FDA-approved options.
However, medical experts emphasize the risks. Dr. Fatima Cody Stanford, an obesity medicine specialist at Massachusetts General Hospital, warned that compounded drugs lack the evidence-based rigor of approved treatments.
“Patients should not be asked to accept unproven therapies simply because effective, FDA-approved options are expensive or difficult to access,” Dr. Stanford said.
The Future of Compounded GLP-1s
U.S. law permits compounding pharmacies to create customized medications in certain situations, but the line between personalized formulations and unauthorized replication of patented drugs is blurring. The FDA’s recent actions signal increased scrutiny of this “gray zone” and suggest that other companies offering unapproved GLP-1 alternatives could face legal challenges.
The fate of individuals relying on compounded GLP-1s remains uncertain as regulators move to enforce stricter controls over drug compounding. The situation highlights the complex trade-offs between expanding medication accessibility and maintaining public health standards.
