Abortion is once again before the Supreme Court — this time, in pill form. Key takeaways from Tuesday’s landmark hearing.
Less than two years after the U.S. Supreme Court overturned the federal right to an abortion established by Roe v. Wade, the conservative-majority court is about to weigh in on the issue yet again. This time, the high court will consider a case that centers around the Food and Drug Administration’s decision to loosen restrictions on how mifepristone, a drug widely used to induce abortions, can be prescribed and dispensed.
During a hearing on Tuesday, Justice Neil Gorsuch said the case “seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action.”
The stakes are high as the decision could affect access to the commonly used abortion medication. Nearly two-thirds of all abortions in the U.S. in 2023 were medication abortions, according to a report from the Guttmacher Institute, a research organization that supports abortion rights.
If the Supreme Court rules against the FDA, restrictions on mifepristone would revert back to what they were when the drug was approved in 2000: Prescriptions would be allowed up to seven weeks of pregnancy instead of 10 weeks; it couldn’t be prescribed over telehealth visits and it wouldn’t be available to be delivered by mail to states that currently allow it. These restrictions would apply not just in states where abortion is currently banned, but also where it’s currently legal.
“I think there's been to some degree a false sense of security created by ballot initiatives [protecting abortion access] in some states,” Mary Ziegler, a law professor at the University of California at Davis, told NPR news. “This is a reminder that what happens in the federal courts can override what voters decide.”
Justices from both sides of the ideological spectrum seemed skeptical about restricting access to the abortion medication. Here is some important context about the cases in question, and key takeaways from Tuesday’s hearing:
The cases before the court:
Mifepristone is one of two pills in a two-step drug regimen to induce an abortion during the early stages of a pregnancy. It’s also used to help with the treatment of miscarriages. Mifepristone, which is often paired with another drug called misoprostol, was approved by the Food and Drug Administration back in 2000.
The Supreme Court on Tuesday heard two cases consolidated together: FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.
The Alliance for Hippocratic Medicine is a group of anti-abortion rights physicians and organizations who originally challenged the FDA’s 2000 approval of mifepristone, claiming the FDA didn’t study it enough and the drug isn’t safe. The case ultimately worked its way through the courts, where their challenge is now focused on actions taken by the FDA in 2016 and 2021 to make the drug more accessible.
Does the plaintiff have the legal standing to challenge the FDA’s approval of mifepristone?
One of the main focuses of Tuesday’s hearing concerned whether or not the plaintiff, the Alliance for Hippocratic Medicine, has the legal standing to challenge the FDA’s approval of mifepristone in the first place. The plaintiff has to show they were harmed in such a way to warrant a court’s intervention.
The Alliance for Hippocratic Medicine argues that doctors they represent are “harmed” as a result of treating patients who have had to go to the emergency room after experiencing complications from a medication abortion, though she could not provide a specific number of patients. Significant side effects to mifepristone include heavy, prolonged menstrual bleeding and bacterial infections, according to the National Institute of Health. More common side effects include abdominal or uterine pain, dizziness and nausea.
“FDA’s outsourcing of abortion drug harm to respondent doctors forces them to choose between helping a woman with a life-threatening condition and violating their conscience,” Erin Hawley, the attorney representing Alliance for Hippocratic Medicine, said during Tuesday’s hearing.
However, the FDA and Danco Laboratories, the manufacturer of mifepristone, argue that the Alliance for Hippocratic Medicine has failed to show evidence that doctors are being forced to treat patients who’ve been harmed by mifepristone.
U.S. Solicitor General Elizabeth Prelogar, representing the FDA, argued during the hearing that the plaintiffs don’t have “a specific example of any doctor” who has had to provide care in “violation of their conscience.”
“They aren't required to treat women who take mifepristone,” Prelogar said of the doctors who claim to have been harmed by the FDA’s guidance on mifepristone. “FDA is not directing the women who take the drug to go seek out care from these specific doctors.”
Justice Elena Kagan, a liberal, also questioned the plaintiff’s legal standing, and pressed Hawley to provide a specific example of a doctor who has suffered as a result of being forced, against their “conscience” to treat a patient harmed by mifepristone.
Hawley gave an example of one doctor whose partner had to perform a dilation and curettage (D&C) due to a life threatening emergency after a woman took an abortion medication. However, Hawley acknowledged that the doctor did not state her objection to performing the procedure at the time.
“The way people with conscience objections do this is they make those objections known," Kagan said. "That may be harder, that may be easier in a particular context but most hospitals have mechanisms in place, routines in place to ensure the doctors who are allowed to do this in advance and are allowed to at the moment.”
If doctors can’t sue the FDA, then who can?
Conservative Justice Samuel Alito pressed Prelogar on the Biden administration’s argument that the doctors who challenged the FDA don’t have the legal right to sue.
“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful?” Alito asked Prelogar. “And maybe what they did was perfectly lawful. But shouldn’t somebody be able to challenge that in court?”
Meanwhile, liberal Justice Sonia Sotomayor proposed a scenario in which a doctor who prescribed a drug and witnessed measurable evidence that changes to the drug’s regulations were causing harm, then could they sue?
Prelogar confirmed that in specific scenarios like that, a court would have the authority to decide.
In-person vs. telehealth prescriptions
In 2021, amid the COVID-19 pandemic, the FDA got rid of a requirement for patients to have an in-person meeting with a doctor in order to receive a prescription for mifepristone. In 2023, the FDA made that decision permanent after reviewing available safety and effectiveness data based on the experiences of millions of people who used mifepristone.
Justice Amy Coney Barrett asked Prelogar about whether the FDA’s elimination of the in-person visit would lead to mistakes in determining how far along the pregnancy is if there wasn’t an ultrasound, increasing the risks of the medication.
Prelogar was quick to point out that even with in-person visits, a patient isn’t necessarily going to get an ultrasound because it has never been required, even with the initial approval of the drug in 2000.
“It’s wrong to suggest that if the court reverses 2021 changes that every woman is going to get an ultrasound,” Prelogar explained.
Obtaining mifepristone by mail
Conservative justices Alito and Thomas referenced the Comstock Act, which is a 19th-century obscenity law that prohibits the mailing of “lewd” materials. In their line of questioning to Prelogar and Jessica Ellsworth, the attorney representing Danco Laboratories, they asked whether the law prevents mifepristone from being dispensed through the mail.
Prelogar said it’s not the FDA’s job to enforce criminal law.
While Ellsworth argued that the court should “think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies.”
What’s next?
Mifepristone access will remain unchanged until the Supreme Court issues a decision, which is expected to come by the end of June or early July.
