FDA Cracks Down on 'Copycat Drugs': Hims Faces Backlash

The FDA is targeting companies like Hims and Hers Health that offer cheaper, non-approved versions of FDA-approved drugs, such as Novo Nordisk's Wegovy weight-loss pill. Hims' compounded drug lacks FDA approval and clinical trial backing, leading to potential legal actions by Novo Nordisk to protect its intellectual property.

The U.S. Food and Drug Administration (FDA) is preparing to take decisive measures against companies involved in the mass marketing of 'illegal copycat drugs.' According to its commissioner, Marty Makary, the FDA aims to stop businesses from claiming that unauthorized compounds are equivalent to FDA-approved medications.

These statements were directed at the recent moves by telehealth company, Hims and Hers Health, which is selling a cheaper version of Novo Nordisk's Wegovy weight-loss pill. Following the remarks, Hims' stock suffered a significant drop, reflecting the market's response to regulatory scrutiny and legal warnings from Novo Nordisk, which emphasizes the lack of proven efficacy in Hims' approach.

Novo has criticized Hims for its mass compounding tactics, stressing that it undermines patient safety and intellectual property rights. Despite Hims' defense of its cost-effective methods, Novo is committed to working with regulators to maintain the quality and safety of FDA-approved GLP-1 medications.