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

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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