The Mifepristone Debate: Legal, Ethical, and Practical Considerations in FDA v. Alliance for Hippocratic Medicine

On March 26th 2024, the U.S. Supreme Court heard oral arguments in a case involving Mifepristone, a popular abortion medication. The case, Food and Drug Administration v. Alliance for Hippocratic Medicine (2024), could result in severely restricted access to the drug if the majority votes in favor of AHM.

Mifepristone is a progesterone blocker that, when used in conjunction with misoprostol, is used to end a pregnancy through ten weeks gestation. Mifepristone was first approved by the FDA in 2000, and in 2016 its access was expanded, meaning that medical practitioners are now able to prescribe and extend its usage in pregnancy 1 [3]. The suit was brought forward after the historic case Dobbs v. Jackson Women's Health Organization (2022) which terminated the constitutional right to an abortion. AHM and other anti-abortion groups challenged the FDA’s approval, claiming the organization had not properly researched the drug prior to approval, and it acted unlawfully when making access to the drug easier. In April of 2023, a federal district court judge sided with the plaintiffs, suspending the FDA’s approval. The U.S. Court of Appeals for the Fifth Circuit partially stayed the judges decision, upholding mifepristone approval, but abandoned the 2016 expanded access. The case was brought to the U.S. Supreme Court, which granted review and stayed the decision of the lower court. According to oral arguments, it seems unlikely that the judges will ban the use of mifepristone, however we cannot expect a ruling until June.

The main subject of the oral arguments surrounded whether or not the AHM had the right to sue in the first place. AHM claims that easily accessible mifepristone may harm doctors who oppose abortion by potentially forcing them to treat women who have had complications from mifepristone, which would go against their moral convictions. A large issue surrounding this argument is its extremely unlikely and hypothetical nature. Solicitor General Elizabeth Prelogar, the defense for the FDA questioned standing for this very reason, stating the argument does not, “come within a hundred miles of the kind of circumstances this Court has previously identified of non-speculative harm that can create the kind of cognizable injury for forward-looking relief.” Because mifepristone has been proven to be an extremely safe drug, and the actual risks the plaintiffs have argued would be exceedingly rare, Prelogar argued that the chances that a woman required such care from a doctor with anti-abortion convictions would be even rarer. Even conservative Justices such as Amy Coney Barret and Brett Kavanaugh held doubts of the AHMs ability to prove the FDAs allowances had directly injured any doctors in this way.

One of the major legal concerns for pro-choice advocates is the application of the Comstock Act. The Comstock Act, a 1873 act, made it “illegal to send “obscene, lewd or lascivious,” “immoral” or “indecent” publications through the mail.” Conservative Justices including Samuel Alito and Clarence Thomas questioned the FDAs apparent failure to apply the Comstock Act when making their 2016 allowances. Jessica Ellesworth, a petitioner for the FDA, argued in response that the application of the Comstock Act would both be a misinterpretation of the law, as well as irrelevant as “This statute has not been enforced for nearly 100 years.” The main complication of the Comstock Act in this application is its fluidity in application and interpretation, however regardless of whether state law permits abortion, a straightforward interpretation of the statute would prohibit all interstate shipment or sale of abortion drugs and devices.

While it seems it is unlikely that the Justices will ban mifepristone, and even more unlikely that the case brought forth by the AHM has standing in itself given the justices' skepticism during oral arguments as well as concerns over public opinion if the justices were to make another ruling restricting abortion access. However, there is still a chance that Justices may side with AHM, if further argument is made for the unsafety of mifepristone. This ruling would be extremely detrimental to the cause of abortion rights activists, as medication abortion accounted for 53% of all facility-based abortions in the United States, and makes abortion accessible for those in rural areas and low-income communities. Furthermore, mifepristone is used for a variety of other purposes, such as miscarriage care, and the treatment of Cushing’s disease, meaning its ban would not only affect abortion rights. More concerningly, the introduction of this dispute has raised further questioning on the application of the Comstock Act and its applicability to the shipment of abortion medication, as well as set a dangerous precedent for large-scale cases against the FDA and is something to pay close attention to as June approaches.