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Breaking Down The Arguments In The Mifepristone Case

 
• By Brenda Sandburg

Chart encapsulates the fundamental questions in Alliance for Hippocratic Medicine v. FDA and the arguments of both parties on standing to sue, the agency’s approval standards, REMS changes, and the Comstock Act of 1873.

Opposing sides
FDA squares off against Alliance for Hippocratic Medicine in battle over mifepristone • Source: Shutterstock

The landmark litigation attempting to remove mifepristone from the market involves issues central to the US Food and Drug Administration’s regulation of drug products. The outcome will impact who is able to file suit to seek reversal of a drug approval and whether courts can set aside the agency’s evaluation of scientific data.

Below are the arguments the parties made in filings with the US Court of Appeals for the Fifth Circuit. The FDA appealed a district court order suspending the agency’s 2000...

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