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Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges

 
• By Sue Sutter

Disputes over orphan and new clinical investigation exclusivity are among the early drug and biologic cases where legal filings cite the Loper Bright decision, which overturned the Chevron doctrine of deference to agency actions.

Small wave
A wave of drug and biologic lawsuits citing the Loper Bright decision is building. • Source: Shutterstock

Legal challenges of US Food and Drug Administration exclusivity determinations are among the early cases where the Supreme Court’s overturning of the Chevron doctrine of deference is being cited.

The 28 June decision in Loper Bright v. Raimondo and Relentless v. Department of Commerce is being used in drug and biologic litigation by plaintiffs, who assert FDA decision-making should...

Key Takeaways

  • Parties involved in litigation with the FDA over drugs and biologics are starting to cite the Supreme Court’s Loper Bright decision in court filings.

  • ...

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