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Deference No More: More Challenges Against US FDA After Supreme Court Tosses Chevron Doctrine?

 
• By Sue Sutter

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Floodgates
• Source: Shutterstock

The US Supreme Court’s elimination of the Chevron doctrine of judicial deference is expected to invite more legal challenges to Food and Drug Administration decisions based primarily on interpretations of regulation or statute, but have less impact on the agency’s scientific determinations, such as drug reviews.

However, the agency will spend more time thoroughly documenting decisions, such as those involving marketing exclusivity, and may need congressional clarity of its ability

Key Takeaways

  • The Supreme Court overturned the Chevron doctrine, which allowed courts to award deference to federal agency decisions that are a permissible interpretation of an ambiguous statute.

  • The move is expected to result in more lawsuits against FDA decisions that are based on interpretations of statute or regulation, such as marketing exclusivity awards

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