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SCOTUS' Mifepristone Decision Sets High Bar For US FDA Suits

Agency Authority Still Faces Risks

 
• By Sarah Karlin-Smith

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

female athlete performing high jump
The US Supreme Court abortion pill opinion sets a high bar for FDA lawsuits, but future tests of FDA's authority remain a risk. • Source: Shutterstock

The US Supreme Court’s unanimous decision to dismiss a high-profile case challenging the US Food and Drug Administration’s regulation of the abortion pill mifepristone on the grounds the plaintiff lacked standing set a high bar for future legal challenges of the agency decisions.

Key Takeaways

  • The unanimous Supreme Court ruling in the mifepristone case will limit the types of challenges that can be brought against FDA approval decisions and create some stability and predictability for industry.

But the 13 June ruling does not reassure that the court would defer to the FDA’s expertise and refrain...

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