HHS asks Justice Department to probe Hims & Hers over its cheaper compounded version of Wegovy - statnews.com

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, marketed at €41, has been criticized by Novo Nordisk, the manufacturer of Wegovy, which has labeled it an "untested knockoff." Novo Nordisk has raised concerns regarding the safety and efficacy of Hims & Hers' product, prompting the company to cease its sale amid regulatory scrutiny. In addition to the investigation by HHS, Novo Nordisk has filed a lawsuit against Hims & Hers for allegedly infringing on a key patent related to Wegovy. The lawsuit is a response to 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. The situation has broader implications for the pharmaceutical and telehealth industries, raising concerns about the legality and ethical considerations of producing compounded medications that mimic established drugs. The ongoing investigation by the FDA and the lawsuit from Novo Nordisk signal a significant regulatory crackdown on companies involved in the mass marketing of unapproved compounded versions of GLP-1 drugs used for weight management. Hims & Hers' decision to abandon the sale of its compounded weight-loss pill reflects the challenges faced by companies in the rapidly evolving telehealth market. The legal battle between Hims & Hers and Novo Nordisk underscores the tensions between established pharmaceutical companies and emerging telehealth providers, particularly in the context of weight-loss treatments and compounded medications. The outcome of this case could have significant repercussions for both companies and the compounding pharmacy sector as a whole.