In a significant development within the healthcare and pharmaceutical sectors, Hims & Hers announced the cessation of sales for what it described as a more affordable compounded version of Novo Nordisk’s obesity medication. This decision comes in response to mounting scrutiny from health authorities regarding potential violations of federal law.
The company had introduced its compounded drug at a competitive price of $49 per month, following the recent release of Novo Nordisk’s FDA-approved oral version of Wegovy, which retails between $149 and $299 monthly. Novo Nordisk promptly expressed its concerns about Hims’ actions, arguing that the mass production of compounded versions of brand-name drugs should only occur under circumstances of genuine drug shortages.
The situation escalated when the Food and Drug Administration (FDA) pledged to take significant measures against companies like Hims that promote unapproved compounded versions of GLP-1 medications. On the following day, the Department of Health and Human Services (HHS) requested an investigation by the Department of Justice (DOJ) into Hims for its business practices concerning the compounded drug.
These developments place Hims & Hers at the center of a regulatory storm, highlighting the delicate balance between innovation in telehealth and compliance with established pharmaceutical laws. The outcome of this investigation could have broader implications for how compounded drugs are marketed and sold in the future.
