• The Supreme Court heard oral arguments in Food and Drug Administration v. Alliance for Hippocratic Medicine, et al., Docket No. 23-235, on March 26, 2024, concerning the widely used abortion medication mifepristone and the FDA’s 2016 and 2021 Amendments that changed its availability.
• The Justices’ questioning focused on Article III standing, including the sufficiency of the alleged underlying injury and whether a nationwide ban on mifepristone would be the appropriate remedy.
• If standing requirements are met, then the merits issue will likely turn on whether the FDA’s 2016 and 2021 Amendments were “arbitrary and capricious” in violation of the APA. The FDA maintains that the Amendments adequately considered the available evidence and case studies and were within the realm of reasonableness.

Nearly two years after the Court overturned Roe v. Wade in June 2022, additional challenges are being brought that may limit access to abortion in the U.S. Mifepristone was originally approved in 2000 by the U.S. Food and Drug Administration (“FDA”). The case concerns certain amendments by the FDA to its regulations that eased restrictions on accessing the drug. Specifically, in 2016, the FDA approved the use of mifepristone for up to 10 weeks of pregnancy instead of the previous seven weeks. And, in 2021, the FDA eliminated the requirement for an in-person visit to a doctor, allowing patients to receive their prescriptions at pharmacies or by mail.

Challenging these amendments, the Alliance for Hippocratic Medicine (“the Alliance”), an association of anti-abortion doctors, filed this lawsuit seeking a nationwide injunction to ban mifepristone. The outcome of this case could have a significant impact, as more than half the women in the U.S. who choose to terminate a pregnancy do so by mifepristone or similar medications. For more background on this case, see our previous blog post here. The key legal issues discussed during the oral arguments included threshold issues under Article III standing requirements and issues on the merits under the Administrative Procedure Act (“APA”). 

On Article III Standing

Most of the Justices’ questions focused on the threshold issue of standing. Under Article III of the Constitution, the plaintiff must demonstrate that it has “standing to sue,” meaning the party has (1) an actual, concrete, and particularized injury that is (2) traceable to the defendant’s allegedly unlawful acts and (3) redressable by a favorable judicial decision. 

Injury. In this case, members of the Alliance claim an injury of alleged violations to their “conscience objections” to performing medical procedures arising from the use of mifepristone. Under federal law, conscience objections protect heath care providers from discrimination should they refuse to participate in certain procedures or services based on moral or religious grounds. The Alliance argued that (1) some percentage of women who take mifepristone may suffer an adverse event from the drug and will end up going to the emergency room for treatment; (2) some percentage of those women will be met by members of the Alliance who have a conscience objection to performing procedures to address her needs; and (3) those doctors will be required to perform procedures or offer services despite their objection due to the nature of the circumstances. Many of the Justices’ questions focused solely on this threshold question of actual injury and whether organizational standing may be satisfied, which would also require a member of the Alliance to suffer a concrete harm.

Justice Kagan critiqued the Alliance’s theory of injury based on its proposed chain of events as too “probabilistic.” However, Justice Alito pointed out that, in prior cases, parties had cleared the injury prong based on similar “probabilistic” injuries. These questions suggest that the Supreme Court could dismiss the case on the issue of standing, although Justice Alito raised concerns about who, if anyone, may ever challenge the FDA on similar issues—wondering whether the agency is “infallible.” 

Traceability. The Justices also asked limited questions on the traceability prong of standing. Based on the questions, they appeared doubtful that the alleged injury could be directly traceable to the 2016 and 2021 FDA amendments. Justice Barrett’s line of questioning of Solicitor General Elizabeth Prelogar on behalf of the FDA revealed that, since the initial approval of the drug in 2000, it has never been a requirement that a woman receive an in-person ultrasound in the first place; therefore it is dubious as to whether the amendments are causally linked to an increase in harms, such as the potential need for a D&C, that may result from mistakes in gestational aging that an ultrasound could have prevented. The FDA’s position is that none of the alleged injuries are traceable to the changes the FDA made in 2016 and 2021, as opposed to the availability of mifepristone in general. 

Redressability. A few Justices expressed concern about redressability of the alleged injuries and the severity of a nationwide injunction as a remedy. Redressability in this action will likely turn on the precise scope of relief to be granted. The Alliance, in advocating for a complete ban on mifepristone, primarily argued that the doctors’ right to raise conscience objections was “impractical” and ineffective in many situations. It argued that doctors cannot always exercise their right to object to providing care because, given the life-threatening nature of many of the mifepristone complications, the doctors often cannot determine the root cause of the patient’s complications until after they have already performed procedures on those patients. And by then, even if the problem turns out to be due to a failed medication abortion, it is too late to object. 

It remains to be seen whether this argument will be sufficient to overcome the concerns by the Court regarding the Alliance’s request for a nationwide injunction. Justice Jackson questioned whether a nationwide ban on mifepristone would be a “plainly overbroad” remedy. Justice Gorsuch, too, expressed concerns about turning this lawsuit into a “nationwide legislative assembly on an FDA rule.” Even if the Court were to find that the Alliance has satisfied the other requirements of standing and is successful on the merits, it will have to find a way to grant the appropriate scope of relief.

On the Merits

Although much of the arguments were centered on Article III standing, some of the Justices briefly addressed the merits of the case and whether the FDA’s changes to methods for prescribing mifepristone were arbitrary and capricious under the APA. When questioned by Justices Alito, Sotomayor, and Barrett about various safety risks associated with taking mifepristone, Solicitor General Prelogar noted that all drugs on the market necessarily carry some degree of health risk and that the FDA carefully reviewed sufficient evidence and case studies to inform its conclusion that any increase in risk did not outweigh the need for access. Where there was an increase in emergency room visits after the 2016 amendment, the FDA and Danco Laboratories – the manufacturer of mifepristone – argued that the increase was not due to “adverse events” resulting from mifepristone and that the data were heavily considered and reviewed by the FDA in making its later 2021 amendment. Solicitor General Prelogar stated that, to the government’s knowledge, this case marks the first time that any court has restricted access to an FDA-approved drug by second-guessing the FDA’s expert judgment on drug safety. 

Additional Considerations

Justices Thomas and Alito also asked questions about the Comstock Act, an 1873 law that prohibits the distribution of obscene materials through the mail. Danco Laboratories argued that the Comstock Act has not been enforced in 100 years and is not currently an issue before the Court.

Law clerk Brenna Rosen co-authored this alert.