Appeals Court Decision To Restrict Abortion Pill Reveals FDA Malfeasance

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ALEXANDRIA, VA – Last month, the U.S. Fifth Circuit Court of Appeals placed restrictions on the distribution of the chemical abortion pill Mifepristone after determining that the U.S. Food and Drug Administration (FDA) violated federal law, ignored science, and failed to put the health and safety of women first while placing and keeping the drug on the market.

In Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, the Appeals Court called out the FDA on three key issues. First, the Court found that the FDA treated pregnancy as an “illness” and improperly categorized Mifepristone under an approval protocol meant for drugs treating serious illnesses to get it approved more rapidly. Second, the Court found the FDA knowingly used deficient data (underreported adverse events) to declare Mifepristone as “safe.” And third, the Court determined the FDA violated federal law by choosing not to enforce the requirement for women to get the drug in-person from a medical provider and making it available by mail. While the Fifth Circuit allowed the drug to remain FDA-approved, it reinstated the regulations for in-person visits and mandated the FDA comply with federal law and not allow the drug to be sent by mail.

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