On June 13, 2024, the Supreme Court of the United States unanimously decided to uphold access to mifepristone, one of two pills used in medication abortion. Mifepristone has long been used safely and effectively in medication abortions around the world.
Shortly after the 2022 Dobbs decision that overturned 50 years of abortion rights, anti-abortion groups and doctors challenged the Food and Drug Administration’s 2000 approval of mifepristone and its loosened regulations on how mifepristone is prescribed, arguing that it could not be used safely.
The Conversation asked professors of law Naomi Cahn and Sonia Suter to explain how the Supreme Court case came about and what the ruling means for access to abortion pills and abortion more generally.
How did this case get to the court?
In Food and Drug Administration v. Alliance for Hippocratic Medicine, the plaintiffs argued that the FDA had not adequately tested mifepristone for safety. They also claimed that the FDA’s subsequent changes, which made the drug even more widely available, were also flawed.
In 2016, the FDA expanded the time frame for prescription of mifepristone from seven weeks to 10 weeks gestation and allowed nonphysician health care providers, like nurse practitioners, to prescribe the pill. Then, in 2021, the FDA removed the in-person dispensing requirement and allowed certified pharmacies to distribute it.
What does the decision mean?
As a result of the opinion, the use of mifepristone remains legal in the states that have not banned abortion.
As of June 2024, medication abortion accounts for more than 60% of abortions in the U.S.
In its ruling, the court decided that the plaintiffs did not have standing. Standing is the legal doctrine that limits the type of cases that courts can hear to ones where there are clear and concrete harms to the parties involved.
The court explained the requirement of standing by quoting the late Justice Antonin Scalia, who stated that plaintiffs need to answer “a basic question: ‘What’s it to you?’”
Justice Brett Kavanaugh’s opinion for the court rejected the plaintiffs’ standing for several reasons. First, it noted that the plaintiffs “do not prescribe or use mifepristone” and that the “FDA has not required the plaintiffs to do anything or to refrain from doing anything.” Thus, they are “unregulated parties who seek to challenge FDA’s regulation of others.”
The court ended by noting that even if no one has standing in this particular case, the issue may “be left to the political or democratic processes” through which opponents can voice their “concerns and objections.”
Justice Clarence Thomas concurred, agreeing with the rest of the court while also writing separately to point out that the doctors did not have standing here, just as he believes “abortionists lack standing to assert the rights of their clients.”
Why is this opinion significant?
This case is important because it is the first full Supreme Court opinion since the court’s 2022 opinion in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and found no federal right to an abortion.
In holding that the plaintiffs lacked standing, the court did not address the merits of the claim. This means that the decision maintains the status quo in terms of FDA regulation of abortion pills.
But it is important to emphasize that the opinion did not take on legal questions concerning the validity of the FDA regulations or any other question concerning the FDA’s authority, which means many questions remain unanswered. For example, it is not fully clear to what extent the FDA regulations take precedence over state regulations regarding the prescription of mifepristone, which is at the heart of some of the lower court cases.
Nevertheless, for the moment, the FDA allows mifepristone to be mailed via certified pharmacies and to be prescribed without in-person visits; up to 10 weeks gestation; and by nonphysician health care providers, like nurse practitioners.
Might there be other cases involving abortion pills?
Other cases involving abortion pills are already in lower courts.
First, three states – Idaho, Kansas and Missouri – have indicated that they are ready to challenge the FDA’s decision-making on mifepristone, so the issues in this case might be back at the Supreme Court.
Second, states are already restricting access to the abortion pills. In May 2024, Louisiana made the decision to treat both mifepristone and misoprostol as controlled substances, meaning that the legislature concluded – albeit without scientific evidence – that there are dependence and abuse risks involved in taking the medication. Both pills are used for purposes other than medication abortion.
Third, a federal court judge in North Carolina recently upheld some of the state’s restrictions on medication abortion. This includes a requirement for an in-person consultation 72 hours in advance of the prescription, as well as an in-person examination and ultrasound before prescription. The judge’s reasoning was that these requirements seemingly concerned issues “beyond regulating the safe use of mifepristone,” such as regulating the medical profession.
On the other hand, she struck down the parts of the North Carolina law that prevented patients from receiving the pills through pharmacies and taking them at home. She also blocked the requirement of an in-person follow-up appointment. In her view, these conflicted with the FDA decision to remove those requirements.
Fourth, under a Trump administration, the FDA could decide to revert to the old requirements for prescribing mifepristone. That would be a “highly unusual” approach, but nothing bars that possibility. Moreover, it is a strategy explicitly recommended by anti-abortion activists.
Finally, there is the issue of the meaning and application of an 1873 Victorian statute, the Comstock Act, which criminalizes the mailing or shipping of any “lewd, lascivious, indecent, filthy or vile article” and anything that “is advertised or described in a manner … for producing abortion.” Anti-abortion groups believe this applies to mifepristone.
The Department of Justice, under the Biden administration, has interpreted the statute as only applying if the sender knows the recipient plans to use the pills “illegally” for abortion. However, under another administration, the DOJ might view the reach of the Comstock Act more broadly..
As we have noted before, a broad reading of the act could go beyond a prohibition on mailing the pills, even where abortion is legal; it might also apply to the distribution of any drug or medical tool – beyond just mifepristone – used to perform an abortion. These same tools are also used for other types of obstetrics and gynecology care. This could have the effect of banning abortion across the country, even where states allow abortions..
While the short-term consequences of the ruling leave mifepristone available where it is legal, this is not the last word on access to medication abortion.
The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.
This article was originally published on The Conversation. Read the original article.
