Supreme Court arguments on Monday, regarding the legality of federal regulations allowing the distribution of the abortion drug mifepristone through the mail, hinged on whether the anti-abortion doctors association that brought the case had standing to sue in the first place.
The case, known as FDA v. Alliance for Hippocratic Medicine and combined with a similar case, centers on whether the Food and Drug Administration overlooked health and safety issues when it loosened restrictions around mifepristone, one of the two drugs used in medication abortion, in 2016 and 2021. The FDA approved mifepristone in 2000, and the medication has since been used by nearly 6 million people in the U.S., according to the department.
The case could roll back access to mifepristone, which is generally prescribed as part of a two-drug regimen alongside misoprostol for abortion and miscarriage care through 10 weeks of pregnancy in the U.S.
If the court sides with abortion opponents, mifepristone could be prohibited from being sent through the mail and distributed at large pharmacy chains, even in states where abortion is legal. A ruling for the anti-choice movement could also restrict the use of mifepristone from its current approval of 10 weeks to seven weeks, and end telehealth visits where abortion pills are prescribed.
During arguments, however, a majority of the justices appeared highly skeptical of whether the doctors organization Alliance for Hippocratic Medicine could even sue to begin with. Plaintiffs are required to show real harm in order to obtain standing to sue and, from the moment arguments began, the justices homed in on whether the group, and specifically the doctors cited as examples in its briefs, had proven harm.
Conservative Justices Clarence Thomas and Samuel Alito and Chief Justice John Roberts all also questioned who would have standing if the Alliance for Hippocratic Medicine didn’t.
Thomas and Alito asked Solicitor General Elizabeth Prelogar whether anyone would have standing to sue.
“If we agree with you on standing, could you give us an example on who would have standing to challenge these FDA actions?” Thomas asked her.
Roberts wanted to know whether the alliance could obtain standing if FDA data showed a “significant number of consequences” or “higher likelihood of an emergency room visit” from the change in the agency’s rules for mifepristone distribution.
Meanwhile, Alito, the author of the court’s 2022 majority decision overturning Roe v. Wade, pressed Prelogar on whether there is “anybody who could challenge in court the lawfulness of what the FDA did here?”
These questions suggested that even the court’s most conservative justices saw the alliance’s standing argument as tenuous at best.
Conservative Justice Neil Gorsuch went further, lambasting cases like this one where a plaintiff fails to show significant harm in a case seeking sweeping nationwide relief.
“We’ve had, one might call, a rash of universal injunctions or vacaturs,” Gorsuch said, referencing cases seeking to block federal government actions. “This 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.”
Justice Elena Kagan repeatedly questioned Erin Hawley, senior counsel for Alliance for Defending Freedom, which represented Alliance for Hippocratic Medicine, about the plaintiffs’ standing for the case, which Kagan described as “probabilistic.”
“You need a person. You need a person to come in and meet the court’s regular standing requirements. So who’s your person? I know you have seven of them,” Kagan asked Hawley, referring to the anti-abortion doctors who joined Alliance for Defending Freedom’s case.
Justice Ketanji Brown Jackson described the injury claimed by plaintiffs as a “significant mismatch,” referring to doctors who object to abortion and their requested solution to roll back access to mifepristone around the country.
“It makes perfect sense for the individual doctors to seek an exemption, but as I understand it, they already have that,” Jackson said. “And so what they’re asking for here is that, in order to prevent them from possibly ever having to do these kind of procedures, everyone else should be prevented from getting access to this medication. So, why isn’t that plainly overbroad scope of the remedy the end of this case?”
Since the Supreme Court repealed federal abortion protections in 2022, more than a dozen states have enacted abortion restrictions or near-total bans, making access to abortion pills via mail critically important. The COVID-19 pandemic led to the loosened restrictions on mifepristone in 2021, sparking a rise of online pharmacies in the U.S. that ship abortion pills directly to patients’ homes.
Mifepristone and misoprostol are more than 95% effective and safer than Tylenol; and over 100 studies have corroborated its safety and effectiveness. Medication abortion accounts for 63% of abortion care in the U.S., according to a new study from the Guttmacher Institute.
The lawsuit was originally filed in Amarillo, Texas, in 2022 by five anti-abortion medical groups, collectively named Alliance for Hippocratic Medicine, in a strategy known as “judge shopping.” The far-right Christian group filed a lawsuit that was full of misleading claims about mifepristone and lacked science-based evidence. They alleged that mifepristone is dangerous and the FDA unlawfully approved the drug when it first went to market over two decades ago, despite the statute of limitations for such claims being six years.
U.S. District Court Judge Matthew Kacsmaryk, a far-right Donald Trump nominee, agreed with Alliance despite the complainants’ lack of standing to bring the case in the first place. Kacsmaryk ruled that the FDA “manipulated and misconstrued” certain parts of the drug approval process in order “to greenlight elective chemical abortions on a wide scale.”
The Biden administration quickly appealed, handing the case to one of the most conservative courts in the entire country, the 5th Circuit Court of Appeals. The 5th Circuit ruled that it was too late to challenge the 2000 FDA approval of mifepristone, but it could roll back the most recent rules that expanded access to the drug in 2016 and 2021. The court used two studies to justify its ruling, but both have since been retracted by the scientific publisher Sage due to a “lack of scientific rigor.”
The FDA and mifepristone manufacturer, Danco, appealed to the U.S. Supreme Court, which granted a stay that blocked the decision from going into effect. After the case moved through the 5th Circuit, the FDA asked the Supreme Court to take up the case. The oral arguments took place on Tuesday and a ruling is expected in late June.
Major medical groups have repeatedly said that mifepristone is safe and should be accessible to patients across the country. The drug is a “safe, effective and important component of treatment and management for early pregnancy loss … and induced abortion,” the American Medical Association and the American College of Obstetricians and Gynecologists wrote in a letter to the FDA in response to the initial lawsuit filed in 2022.