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Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Spur Delays

 
• By Sue Sutter

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

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What types of FDA disputes are ripe for litigation in a post-Chevron world? • Source: Shutterstock

[Editor’s note: This story appeared first in our sister publication, Pink Sheet.]

Biopharma companies that have a prelitigation dispute with the US Food and Drug Administration will be in a stronger position to argue their views before the agency now that the US Supreme

Key Takeaways

  • Sponsors can take a more forceful position with the FDA in prelitigation disputes now that agency decisions are not afforded Chevron deference by courts.

  • However, sponsors could face the risk of differing decisions on similar issues by federal judges across the country

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