Is a Crackdown on Hims and Compounding Imminent?

Recent developments in the telehealth and pharmaceutical industries have raised concerns about the future of compounded medications. The focus has shifted toward Hims & Hers, a prominent telehealth platform that recently announced its own compounded version of semaglutide, a weight-loss medication.

Government Scrutiny on Compounding Pharmacies

In January 2023, Novo Nordisk launched a pill version of Wegovy, previously available only as an injection. While this transition was celebrated by many, it was not entirely new for American consumers. Many had already accessed various forms of semaglutide, including pills, mints, and gummies, through compounding pharmacies and telehealth companies.

Following the announcement by Hims & Hers regarding their compounded semaglutide, the situation escalated quickly. The Food and Drug Administration (FDA) stepped in, declaring plans to impose restrictions on compounded GLP-1 medications marketed as alternatives to FDA-approved drugs. Notably, Hims was explicitly named in this action.

Investigations and Legal Issues

• The Department of Health and Human Services requested an investigation by the Department of Justice.
• The probe focuses on potential violations of the Food, Drug, and Cosmetic Act (FDCA) by Hims.
• In light of these developments, Hims announced it would cease selling its compounded semaglutide products.

As a further complication, Novo Nordisk filed a patent infringement lawsuit against Hims shortly after they halted sales. This legal action adds tension to an already volatile situation.

Impact on Hims & Hers

The fallout from these events has had a significant effect on Hims & Hers. Since the announcement of their compounded semaglutide, Hims’ stock has plummeted by 35%, reflecting investors’ nervousness about the future of the company amid increasing regulatory scrutiny.

The saga of Hims and the compounded semaglutide raises important questions about the intersection of telehealth services and traditional pharmaceuticals. As regulatory bodies take action, the industry’s landscape may change dramatically in the coming months.