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Reproductive Liberties and Care Access

Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration


Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Tex., Apr. 7, 2023): District Court Judge Matthew Kacsmaryk struck down FDA’s prior approval of mifepristone, a drug used in medication abortion, in a challenge seeking to eliminate U.S. availability of the drug. Typically, medication abortion occurs via the use of two drugs together—mifepristone and misoprostol. The availability of medication abortion helped offset serious impacts to abortion access in the U.S. following the Supreme Court’s overturning Roe v. Wade in Dobbs v. Jackson Women’s Health Organization in June 2022.

Anti-abortion advocates including the Alliance challenged FDA’s mifepristone approval on November 18, 2022, over 20 years after FDA first approved it in 2000. They argued primarily that FDA “lacked legal authority” to approve mifepristone and that mailing abortion drugs violates the federal Comstock Act of 1873. Judge Kacsmaryk, an appointee of President Donald Trump, agreed with the Alliance, concluding that pregnancy is not an “illness” addressable by FDA’s mifepristone approval and that “[c]hemical abortion drugs do not provide a ‘meaningful therapeutic benefit,’” contrary to FDA’s expert analysis. The judge also found that the Comstock Act “prohibits the mailing of chemical abortion drugs,” disagreeing with an earlier Department of Justice interpretation. His decision draws on slim scientific evidence which FDA had already considered and found irrelevant or mischaracterized by the challengers.

Judge Kacsmaryk’s order also indicates support of “fetal personhood,” e.g., bestowing a fetus with all rights and privileges extended to humans under the U.S. Constitution. In assessing whether the FDA’s actions caused irreparable injury to the challengers, Judge Kacsmaryk opined that the analysis also “arguably applies to the unborn humans extinguished by mifepristone.” Finally, whether the challengers were even able to bring the suit in the first place involves questions of standing, which generally requires parties to prove that they have experienced, or imminently will experience, a concrete and particularized injury. Several analyses of the standing issues in this case indicate that the challengers did not have any such injury, and the suit should not have been allowed to move forward. Judge Kacsmaryk’s decision is another in a long line of individually-authored decisions this decade seriously limiting public health and health authorities nationwide. Read the full decision here.

Judge Kacsmaryk stayed his order for seven days to allow the FDA to appeal his ruling. Within hours, both the FDA and Danco Laboratories, LLC (the manufacturer of Mifeprex) filed notices of appeal with the Fifth Circuit Court of Appeals.

View all cases in Judicial Trends and Public Health – April 13, 2023

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