STAT+: HHS asks Justice Department to probe Hims & Hers over its cheaper compounded version of Wegovy

The U.S. Department of Health and Human Services (HHS) has requested the Justice Department to investigate Hims & Hers, a telehealth company, for its sale of a compounded version of the obesity drug Wegovy. This compounded version was marketed at €41 and has faced criticism from Novo Nordisk, the manufacturer of Wegovy, which labeled it an “untested knockoff.” Novo Nordisk has raised concerns regarding the safety and efficacy of Hims & Hers' product, leading to significant regulatory scrutiny. In addition to the investigation by HHS, Novo Nordisk has initiated legal action against Hims & Hers for allegedly infringing on a key patent related to Wegovy. The lawsuit stems from Hims & Hers' offering of a lower-priced compounded version of the drug, which Novo Nordisk has described as “illegal mass compounding.” The chief counsel of Novo Nordisk has warned that telehealth companies and compounding pharmacies producing similar versions should be “very, very much on notice” regarding the legal implications of their actions. In response to the ongoing legal challenges and the investigation by the FDA, Hims & Hers has decided to cease the sale of its compounded weight-loss pill. The company had been criticized for its marketing of this alternative, which raised broader concerns within the pharmaceutical and telehealth industries about the legality and ethical implications of producing compounded medications that mimic established drugs. The situation highlights the tensions between established pharmaceutical companies and emerging telehealth providers, particularly in the context of weight-loss treatments and compounded medications. The outcome of the lawsuit and the investigation could have significant repercussions for both Hims & Hers and Novo Nordisk, as well as the compounding pharmacy sector as a whole.