Fifth Circuit Court of Appeals Determines that FDA’s 2016 and 2021 Changes to Mifepristone Were Unlawful

Today, a three-judge panel of the Fifth Circuit Court of Appeals, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), determined that when the FDA loosened regulations in 2016 and 2021 regarding the drug mifepristone, it did so unlawfully, failing to give adequate consideration to demonstrated safety issues with the drug. Today’s decision will not impact the distribution of the abortion drug Mifeprex (generic: mifepristone) until the U.S. Supreme Court weighs in. The Fifth Circuit Court of Appeals concluded that the FDA’s actions loosening the regulations involving Mifeprex were unlawful. Today’s ruling, though not in effect because of the prior stay by the Supreme Court, would also reinstate long-standing safety protocols for women which were removed during COVID and made permanent because of pro-abortion pressure on the FDA. In today’s decision, the court noted: ‘We affirm the portions of the stay order regarding the 2016 Amendments and the 2021 Non-Enforcement Decision. In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it.’