Lilly asks court to force FDA to classify obesity product as biologic

Eli Lilly has filed a lawsuit seeking to force FDA to reverse its decision to classify retatrutide as a drug. Classifying the investigational anti-obesity product as a biologic could extend the duration of its exemption from Medicare drug price negotiation by four years, which could increase Lilly’s revenues by billions of dollars.

The lawsuit could also provide clues about how vulnerable FDA regulatory decisions will be to legal challenges in the aftermath of the Supreme Court’s recent decision in Loper Bright Enterprises v. Raimondo that overturned the Chevron doctrine and scrapped the deference courts have traditionally given federal agencies to interpret ambiguous laws. ...