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In less than a month, the Supreme Court of the United States is expected to hear arguments in Food and Drug Administration v. Alliance for Hippocratic Medicine, a case challenging the agency’s deregulation of chemical abortion drugs in 2016 and 2021. According to the Guttmacher Institute, abortion medication accounted for 53% of all facility-based abortions in the United States in 2020. Preliminary data published in 2022 indicated it accounted for 54% of all abortions.

In 2016, the Food and Drug Administration (FDA) removed patient safeguards, including the obligation of in-person administration of misoprostol and a follow-up appointment. Five years later, the FDA removed the in-person dispensing requirement, which allowed mifepristone to be prescribed remotely and sent via mail. In April, the Fifth Circuit affirmed a stay of the FDA’s 2016 and 2021 actions, stating the actions likely violated the Administrative Procedure Act.

For the first time since Dobbs v. Jackson Women’s Health Organization, the issue will come before the Supreme Court on March 26, 2024. Justices will examine whether the agency’s actions to deregulate mifepristone were arbitrary and capricious and if the district court properly granted preliminary relief. Additionally, the court will decide if the respondents have the legal standing to challenge the FDA’s actions pertaining to the approved conditions of mifepristone’s use.

U.S. Senator Kevin Cramer (R-ND) joined U.S. Senator Cindy Hyde-Smith (R-MS), U.S. Representative August Pfluger (R-TX-11), and their colleagues in filing an amicus brief in support of the plaintiffs, led by the Alliance for Hippocratic Medicine. As pro-life elected representatives, the bicameral group of lawmakers explained they are committed to protecting women and adolescent girls from the harms of the abortion industry. The FDA’s actions have only endangered women seeking chemical abortions.

Throughout the amicus brief, the lawmakers argue the failure by the FDA to adhere to the Federal Food, Drug, and Cosmetic Act (FDCA) breaches patient safeguards and has resulted in health and safety risks to women and girls; the chemical abortion drugs carry significant risks; the actions taken by the FDA has endangered patient health and safety; and the decision to permit mail-order chemical abortion drugs is a violation of federal law.

“Amici agree with Respondents that they have standing to challenge the FDA’s unlawful deregulation of mifepristone in this case,” the lawmakers wrote. “Amici write separately to contribute a federal policy perspective as to why the FDA, in deregulating mifepristone, acted arbitrarily and capriciously in violation of the APA, by (I) subverting its obligations under the FDCA to ensure new drugs are safe and effective; and (II) blatantly disregarding the federal law’s prohibition on the mailing and interstate shipment of abortion- inducing drugs.”

“The FDA’s unlawful deregulation of chemical abortion drugs has endangered patient health and safety,” the lawmakers concluded. “For the reasons set forth above, Amici urge this Court to affirm the Section 705 stay of the FDA’s 2016 and 2021 unlawful actions.”

Click here to read the amicus brief.

Author: Press Release


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