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On Tuesday, the Supreme Court of the United States will hear oral arguments in a challenge to abortion pill access across the country, including in states where abortion is legal. The stakes for abortion rights are sky-high, and the case is the most consequential battle over reproductive health care access since Roe v. Wade was overturned in 2022.
At the center of this fight is mifepristone, a pill that blocks a hormone needed for pregnancy. The drug has been approved by the US Food and Drug Administration for more than two decades, and it’s used to treat some patients with Cushing’s syndrome, as well as endometriosis and uterine fibroids. But its primary use is the one contested now—mifepristone is the first of two pills taken in the first 10 weeks of pregnancy for a standard medication abortion, along with the drug misoprostol.
If the justices side with the antiabortion activists seeking to limit access to mifepristone, it could upend nationwide access to the most common form of abortion care. A ruling that invalidates mifepristone’s approval would open the door for any judge to reverse the FDA approval of any drug, especially ones sometimes seen as controversial, such as HIV drugs and hormonal birth control. It could also have a chilling effect on the development of new drugs, making companies wary of investing research into medicines that could later be pulled from the market.
Pills are now the leading abortion method in the US, and their popularity has spiked in recent years. More than six in 10 abortions in 2023 were carried out via medication, according to new data from the Guttmacher Institute. Since rules around telehealth were relaxed during the Covid-19 pandemic, many patients seeking medication abortions have relied on virtual clinics, which send abortion pills by mail. And it keeps getting more popular: Hey Jane, a prominent telemedicine provider, saw demand increase 73 percent from 2022 to 2023. It recorded another 28 percent spike comparing data from January 2023 to January 2024.
“Telemedicine abortion is too effective to not be in the targets of antiabortion folks,” says Julie F. Kay, a longtime reproductive rights lawyer and director of the advocacy group Abortion Coalition for Telemedicine.
Tomorrow’s argument comes after a long, tangled series of legal disputes in lower courts. The Supreme Court will be hearing two cases consolidated together, including FDA v. Alliance for Hippocratic Medicine, in which a coalition of antiabortion activists filed a suit challenging the FDA’s approval of mifepristone, asking for it to be removed from the market. The Alliance for Hippocratic Medicine is represented by the Alliance Defending Freedom, a right-wing Christian law firm that often takes politically charged cases.
Despite decades of scientific consensus on the drug’s safety record, the Alliance for Hippocratic Medicine has alleged that mifepristone is dangerous to women and leads to emergency room visits. A 2021 study cited by the plaintiffs to back up their claims was retracted in February after an independent review found that its authors came to inaccurate conclusions.
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In April 2023, the Trump-appointed judge Matthew Kacsmaryk of the Northern District of Texas issued a preliminary ruling on the FDA case invalidating the agency’s approval of mifepristone. The ruling sent shock waves far beyond the reproductive-rights world, as it had major implications for the entire pharmaceutical industry, as well as the FDA itself; the ruling suggested that the courts could revoke a drug’s approval even after decades on the market.
The US 5th Circuit Court of Appeals narrowed Kacsmaryk’s decision a week later, allowing the drug to remain on the market, but undid FDA decisions in recent years that made mifepristone easier to prescribe and obtain. That decision limited the time frame in which it can be taken to the first seven weeks of pregnancy and put telemedicine access, as well as access to the generic version of the drug in jeopardy.
Following the 5th Circuit ruling, the FDA and Danco Laboratories sought emergency relief from the Supreme Court, asking the justices to preserve access until it could hear the case. In its legal filing, Danco aptly described the situation as “regulatory chaos.”
Scotus issued a temporary stay, maintaining the status quo; the court ultimately decided to take up the case in December 2023.
As all this was unfolding, pro-abortion-rights states across the country were passing what are known as shield laws, which protect medical practitioners who offer abortion care to pregnant patients in states where abortion is banned. This has allowed some providers, including the longtime medication-abortion-advocacy group Aid Access, to mail abortion pills to people who requested them in states like Louisiana and Arkansas.
Though the oral arguments before the Supreme Court begin on Tuesday, it will likely be months before a ruling. Court watchers suspect a decision may be handed down in June. With the US presidential election in the fall, the ruling may become a major campaign issue, especially as abortion access helped galvanize voters in the 2022 midterms.
If the Supreme Court agrees with the plaintiffs that mifepristone should be taken off the market, some in the pharmaceutical industry worry that it will undermine the authority of the FDA, the agency tasked with reviewing and approving drugs based on their safety and efficacy.
“This case isn't about mifepristone,” says Elizabeth Jeffords, CEO of Iolyx Therapeutics, a company developing drugs for immune and eye diseases. Jeffords is a signatory on an amicus brief filed in April 2023 that brought together 350 pharmaceutical companies, executives, and investors to challenge the Texas district court’s ruling.
“This case could have easily been about minoxidil for hair loss. It could have been about Mylotarg for cancer. It could have been about measles vaccines,” Jeffords says. “This is about whether or not the FDA is allowed to be the scientific arbiter of what is good and safe for patients.”
Greer Donley, an associate professor of law at the University of Pittsburgh and an expert on abortion on the law, doesn’t think it’s likely that the court will revoke mifepristone’s approval entirely. Instead, she sees two possible outcomes. The Supreme Court could dismiss the case or could undo the FDA’s decision in 2023 to permanently remove the in-person dispensing requirement and allow abortion by telehealth. “This would be an even more narrow decision than what the 5th Circuit did, but it would still be pretty devastating to abortion access,” she says.
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The Supreme Court could also decide that the plaintiffs lack a right to bring the case to court, says David Cohen, a professor of law at Drexel University whose expertise is in constitutional law and gender issues. “This case could get kicked out on standing, meaning that the plaintiffs aren't the right people to bring this case,” he says. “If most of the questions are about standing, that will give you a sense that that's what the justices are concerned about.”
As the current Supreme Court is considered virulently antiabortion, reproductive-health-care workers are already preparing for the worst. Some telehealth providers have already floated a backup plan: offering misoprostol-only medication abortions. This is less than ideal, as the combination of pills is the current standard of care and offers the best results; misoprostol on its own can cause additional cramping and nausea. For some providers who may have to choose between misoprostol-only or nothing, it’s better than nothing.
Abortion-rights activists have no plans to give up on telehealth abortions, regardless of the outcome of this particular case. “Let us be clear, Hey Jane will not stop delivering telemedicine abortion care, regardless of the outcome of this case,” says Hey Jane’s CEO and cofounder, Kiki Freedman.
“They’re not going to stuff the genie back in the bottle,” Kay says.
