Hims & Hers Weight-Loss Pill Plan Sparks FDA Warning and Lawsuit

Post by : Saif Nasser

Telehealth company Hims & Hers Health is facing serious pressure after its plan to launch a low-cost weight-loss pill quickly backfired. What was meant to boost growth has instead drawn regulatory warnings and legal action.

The company announced it would offer a compounded oral version of semaglutide for $49. Semaglutide is the active ingredient in popular weight-loss drugs such as Wegovy, produced by Novo Nordisk, and similar treatments from Eli Lilly. These branded medicines are usually much more expensive.

Only two days after the announcement, U.S. Food and Drug Administration Commissioner Marty Makary warned that the pill could be seen as an “illegal copycat.” Soon after, Novo Nordisk filed a lawsuit claiming patent infringement. Faced with strong criticism, Hims stepped back from its plan.

The weight-loss drug market has grown very quickly. Experts believe it could reach $100 billion a year by 2030. Pills are especially appealing because many patients prefer swallowing a tablet instead of using injections. For Hims, this seemed like a major chance to expand its customer base.

During past shortages of GLP-1 drugs, compounding pharmacies were allowed to make custom versions. These versions were meant to help patients when supply was limited. But now that supply has improved and prices are being reduced by major drugmakers, regulators are watching more closely.

Turning GLP-1 medicines into effective pills is not simple. Novo Nordisk uses patented technology to help the drug be absorbed properly in the body. Hims said it planned to use liposomal technology, which wraps the medicine in tiny particles to help delivery. Experts say this method is complex and hard to produce safely in personalized doses.

If the process is not exact, the drug may not work correctly. It could also create safety risks. Because of these concerns, regulators reacted quickly to protect patients and enforce patent rules.

Hims & Hers has grown fast in recent years. It began with sexual health products and later expanded into mental health and weight-loss treatments. After launching injectable GLP-1 offerings, its revenue increased sharply. Sales are expected to pass $2 billion for 2025.

However, growth is now expected to slow. The company’s shares have dropped since the pill announcement. Investors appear worried about legal risks and the future direction of the business.

Large pharmaceutical companies have strong advantages. They have advanced technology, large manufacturing capacity, and legal protection for their products. As prices fall and insurance coverage improves, demand for compounded versions may decline.

This episode shows how risky it can be to compete in a fast-moving and highly regulated market. While affordable healthcare options are important, companies must follow strict safety and patent rules.

Hims & Hers now faces a key moment. It must decide how to continue growing without stepping into legal trouble. The weight-loss market still offers opportunity, but success will require careful planning and respect for regulations.