FDA Cracks Down on Copycat Drug Market Amid Hims Controversy

The FDA is set to take action against companies selling unapproved copycat drugs, as seen in the case of Hims and Hers Health marketing a cheaper version of Novo Nordisk's Wegovy weight-loss pill. The compounded drug lacks FDA approval, raising concerns about safety and efficacy.

The U.S. Food and Drug Administration (FDA) is poised to clamp down on companies marketing unapproved drugs that mimic FDA-sanctioned products. Commissioner Marty Makary highlighted this concern following Hims and Hers Health's launch of a $49 compounded version of Novo Nordisk's new weight-loss pill, Wegovy.

The announcement caused a 10% drop in Hims' stock during after-hours trading. The FDA has not verified the compounded drug's quality or efficacy. Compounded drugs often arise from pharmacies mixing ingredients, offering cheaper alternatives to existing medicines.

Both Novo Nordisk and Eli Lilly are affected, with the latter seeing a slight rise in stock prices as predictions of future copycat versions emerge. Novo's CEO criticized the Hims' pill, emphasizing the proprietary technology in their weight-loss solution.