FDA Cracks Down on Copycat Drugs as Telehealth Firms Enter Fray

The U.S. FDA plans to act against companies marketing illegal copycat drugs. Commissioner Marty Makary's remarks follow Hims and Hers Health's introduction of a cheaper, non-FDA-approved version of Novo Nordisk's Wegovy. The regulator stresses the unverified safety of such drugs, leading to a drop in Hims' shares.

The U.S. Food and Drug Administration (FDA) is preparing to take strong measures against companies that promote "illegal copycat drugs," claiming similarity to already approved medications. In a statement on Thursday, FDA Commissioner Marty Makary emphasized the agency's commitment to safeguard the public from unlicensed products.

The announcement follows the move by online telehealth provider Hims and Hers Health to offer a significantly lower-priced $49 compounded variant of Novo Nordisk's newly launched Wegovy weight-loss pill. This product is neither approved by the FDA nor has it undergone the necessary clinical trials to confirm its efficacy and safety.

Makary highlighted the risks involved by posting on a social media platform, emphasizing that the FDA cannot guarantee the safety or effectiveness of non-approved drugs. The news led to a 4.7% decline in Hims' stock during after-hours trading.

(With inputs from agencies.)