The U.S. Food and Drug Administration said on Friday it would take action against telehealth provider Hims & Hers for its $49 weight-loss pill, including restricting access to the drug’s ingredients and referring the company to the Department of Justice for potential violations of federal law.
Federal action to limit the production of compounded drugs would be a win for Novo Nordisk, which has been losing share in the weight-loss market to rival Eli Lilly and telehealth firms like Hims. However, the FDA did not make clear whether it could quickly halt the sale of Hims’ product, the cheapest GLP-1 therapy on the U.S. market.
Shares of Hims fell 14.1% in after-hours trade. The FDA said it plans to restrict GLP-1 ingredients used in non-approved compounded drugs that companies such as Hims and other compounding pharmacies have marketed as alternatives to authorized treatments. The agency cited concerns over quality, safety and potential violations of federal law.
