by Alessia Riccioli*
On June 13, 2024, the Supreme Court unanimously dismissed the pro-life plaintiffs’ stance against the commercialisation of mifepristone, a drug used in a medication abortion (Food and Drug Administration et al. v. Alliance for Hippocratic Medicine). Thus, the same majority that issued the infamous Dobbs decision two years ago, in this case delivered a surprising opinion (indirectly) in favour of the Biden administration [1, 2].
The Food and Drug Administration and the Mifepristone REMS Program
Mifepristone and misoprostol are two drugs involved in medication abortion. Although misoprostol is around 80 percent effective on its own, only the use of mifepristone was concerned by the Supreme Court’s recent decision. Mifepristone blocks a hormone called progesterone and brings on uterine contractions, causing a miscarriage.
The drug is available under a single, shared system risk evaluation and mitigation strategy (REMS), known as the Mifepristone REMS Program, provided by the Food and Drug Administration (FDA). REMS sets the requirements that must be followed for mifepristone for medical termination of pregnancy. In 2000, FDA allowed new mifepristone pills into the market, under the brand name Mifeprex for use in terminating pregnancies up to seven weeks. It provided for some additional restrictions on the drug’s use and distribution to guarantee its safest and most effective use. Thus, Mifeprex could only be taken under medical prescription, and the original dosing regimen required patients to have three in-person visits with the doctor to receive the drug.
In 2019, FDA approved a generic version of Mifeprex (Mifepristone Tablets).
Over the last two decades, the Mifepristone REMS Program relaxed its original restrictions. In 2016, FDA allowed using Mifeprex to terminate pregnancies up to 10 weeks, and a wider range of healthcare providers, such as nurse practitioners, could prescribe it. Moreover, the dosing regimen to receive the drug was changed, requiring just one in-person visit.
Medication abortion represents for women the safest method to have an early abortion. Despite FDA allows it only up to 10 weeks, the 2022 World Health Organization guidelines consider mifepristone safe up to 12 weeks at home and after 12 weeks in a medical office. It must be considered that the vast majority of abortions in U.S. are performed by the 13th week.
More than sixty percent of people who have legal abortions in the U.S. — and even more in Europe —have medication abortion. This method is so convenient also because makes easier to get prescriptions via telemedicine and to fill them in a pharmacy. In 2021, the FDA decided to no longer enforce the initial requirement of the in-person visit, which means that it is no longer necessary to travel to clinics in person, which was crucial during the Covid pandemic.
The mifepristone judicial case
At this point, four pro-life medical associations and several individual doctors moved for a preliminary injunction that would require FDA either to rescind approval of mifepristone or to rescind the FDA’s 2016 and 2021 regulatory actions. Mifeprex (through the Danco Laboratories) intervened to defend the FDA’s actions.
The District Court issued in favour of the plaintiffs and enjoined the FDA’s approval of mifepristone, thereby ordering mifepristone off the market. FDA and Mifeprex appealed. The Fifth Circuit found the plaintiffs likely to succeed at least in their challenge to the FDA’s 2016 and 2021 actions. Thus, it granted certiorari with respect to these drug approvals.
However, the Supreme Court found that plaintiffs had no standing to challenge the FDA’s actions. According to Article III of the Constitution, standing is a “bedrock constitutional requirement”, hence the plaintiff must be involved personally in the judicial dispute. Under Article III, it is not enough to stand for a general legal, moral, ideological, or policy objection to a particular government action.
As argued in this decision, federal courts cannot operate «as an open forum for citizens» to complain against the government’s actions. Moreover, Article III also requires causation, meaning the plaintiff’s injury likely was caused or likely will be caused by the defendant’s conduct.
In this case, the Court found that the pro-life plaintiffs do not have any “personal stance” in the dispute, since they did not prescribe or use mifepristone. They advanced several complicated causation theories that involved the FDA’s actions. For instance, they tried to assert that the FDA’s relaxed regulation of mifepristone might cause downstream conscience injuries to the plaintiff doctors. However, they did provide no proof they could be forced to participate in an abortion in any terms (being protected by the federal-granted conscience objection).
Finally, plaintiffs also tried to suggest that they must had standing because otherwise no one would have stood to challenge the FDA’s 2016 and 2021 actions. The Court did not agree with this assumption, underlining that «some issues may be left to the political and democratic processes».
U.S. after Dobbs and the mail-ordered abortion pills
It is worth noting that the District Court’s decision which took off the market the abortion drug was issued by Judge Matthew J. Kacsmaryk of the Northern District of Texas, a Trump appointee who is a longtime opponent of abortion.
Texas is well-known for having one of the most strict national legislations on abortion. The reference is mainly to the 2021 Texas Heartbeat Act (S.B. No. 8), which bans abortion when the “heartbeat” of the foetus is detected, authorizing a private civil right of action, and the Human Life Protection Act of 2021 (H.B. No. 1280), a so-called “trigger law” approved before and in force after Dobbs [for an overview of the abortion legal framework in Texas: here]
Indeed, the overruling of Roe and Casey surely changed the abortion legal framework, both in and outside the U.S. Since then, nearly two dozen states banned or restricted abortion [for an overall perspective: here and here].
Thus, some women in those states have turned to mail-order abortion pills instead. In 2021, the FDA’s regulation on mifepristone allows prescriptions via telehealth and for the medication to be dispensed by mail-order pharmacies. Despite the right to access mifepristone doesn’t apply in every state, clinicians in several states have mailed pills into states with bans, protected by so-called “shield laws” (such as California, Connecticut, Delaware, Illinois, Massachusetts, New Jersey, and New York) [2]. In addition, foreign nonprofit groups and entrepreneurs have shipped some women pills from overseas. In this regard, it is worth noting that, on the one hand, the Court’s decision did not guarantee access to Mifepristone tablets in states where abortion is completely banned, but on the other it did not concern the availability of the overseas pills – being beyond the legal U.S. health care system.
Conclusion: the ongoing debates on the “a-word”
The new Supreme Court decision on abortion belongs to a worldwide trend that makes abortion at the core of a harsh and fierce political debate. It is a crossfire issue in the presidential campaign between Biden and Trump. The blue candidate has long risen the anti-abortion right-wing populist wave, making the abortion warfare one of the most crucial stances in his politics. As President, he appointed three judges of the Supreme Court, two of them rather known for their anti-abortion position (Neil Gorsuch and Brett Kavanaugh), still shaping the current conservative majority.
However, the Court’s decision is surprising and interesting, since it has been taken by the very same majority that issued Dobbs. It can be interpreted as a partial victory for the Biden administration, which made the battle for the right to abortion (and generally the protection of gender rights) an important part of its political agenda.
So far, the abortion debate has not subsided. This strong polarisation has led to radicalisation, resulting in unbalanced solutions far from the constitutional protection of reproductive health. As we await future developments in the presidential campaign, the hope for a fairer solution does not decrease. The global goal on reproductive health should be to adequately protect women, raising public awareness of the importance of reproductive self-determination for the dignity of us all.
*PhD Candidate, University of Pisa
