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Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn

 
• By Sue Sutter

Determining what falls within the statutory definition of ‘biological product’ is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court’s June decision in Loper Bright.

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The FDA and Lilly disagree on the number and type of "amino acids" that would make retatrutide a biological product. • Source: Shutterstock

Eli Lilly and Company invoked the US Supreme Court's recent opinion overturning the Chevron doctrine of deference in a new lawsuit challenging the US Food and Drug Administration’s determination that its investigational anti-obesity agent retatrutide is a drug, not a biologic.

In a complaint filed 3 September, Lilly asks the US District Court for the Southern District of Indiana to find that the agency improperly interpreted the Public Health Service...

Key Takeaways

  • Lilly is challenging the FDA’s determination that its investigational anti-obesity product retatrutide is a drug, not a biologic.

  • The lawsuit cites the Supreme Court’s...

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