FDA Cracks Down on Copycat Drugs Amid Hims' Controversy

The FDA is poised to take action against companies marketing unauthorized drugs as equivalents to FDA-approved products. Hims and Hers Health's cheaper version of Novo Nordisk's Wegovy pill has spurred legal and market ramifications, with Novo promising a legal challenge and investor responses impacting stock values.

The U.S. Food and Drug Administration (FDA) is gearing up to target companies that commercialize "illegal copycat drugs," as echoed by its commissioner, Marty Makary, on Thursday. This statement followed the introduction by Hims and Hers Health of a $49 compounded variant of Novo Nordisk's Wegovy weight-loss pill. The Hims version lacks FDA approval and the necessary clinical evaluations to confirm its effectiveness, a point highlighted by Makary via the social media platform X.

The FDA remains tight-lipped, offering no additional information immediately. The affordable GLP-1 weight-loss pill's debut by Hims correlated with a drop in Novo and Eli Lilly's share prices, prompting Novo to vow legal action. Noteworthy is the absence of comments from Hims, Novo, and Lilly when approached by Reuters.

Hims' share valuation fell by 14% post-trading hours, a steep decline after an earlier 14% rise. As for Novo, its pills, available since January, are priced at $149 initially, rising to $199 for continued use, contrasting with Hims' $49 introductory and $99 ongoing costs for long-term buyers. Novo has condemned Hims' practices as unlawful and is set to defend its rights and the U.S. drug approval system's integrity.

(With inputs from agencies.)