FDA to act against companies selling 'illegal copycat drugs', chief says

The US Food and Drug Administration (FDA) will take swift action against companies that mass-market "illegal copycat drugs" by claiming they are similar to FDA-approved products, its commissioner Marty Makary said on Thursday.

 

Makary's comments came after online telehealth company Hims and Hers Health began offering a much cheaper $49 compounded version of Novo Nordisk's new Wegovy weight-loss pill. Hims' drug is not FDA-approved and has not gone through clinical trials to prove efficacy.

 

"The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs," Makary said in a post on social media platform X, without naming Hims.

 

The FDA did not immediately respond to a request for further details.

 

Hims' launch of the cheap GLP-1 weight-loss pill sparked a selloff in Novo and Eli Lilly's shares earlier on Thursday. Danish drugmaker Novo has also promised a legal challenge to the move by Hims. 

 

Hims, Novo and Lilly did not immediately respond to Reuters' requests for comment on Makary's statement.

 

Shares of Hims were down 14 per cent in after-hours trade after rising nearly 14 per cent earlier on Thursday. Lilly shares were last up 1.9 per cent.

 

Novo launched its pill in January at $149 for first-time users and $199 after that. Hims is pricing its drug at $49 for the first month and $99 afterwards for those who purchase a five-month plan.

 

Lilly is also expected to launch its pill in April and has promised affordable pricing on the US government's TrumpRx site.

 

Novo called Hims' mass compounding illegal and said it will take "take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval ​framework".

 

Hims denied that it had compromised on safety or efficacy and that it uses a technology based on liposomes that is intended to support absorption.  

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