Abortion-pill challenge provokes doubt from US Supreme Court
Lawsuit could roll back access to mifepristone, a drug widely used to induce abortion in the United States
Members of the US Supreme Court expressed skepticism today about arguments from a group of anti-abortion organizations and physicians seeking to restrict use of the abortion drug mifepristone in the United States. The group is challenging the US Food and Drug Administration’s decision to expand access to the medication.
The justices must decide whether the challengers are qualified to bring suit in the first place — in legal terms, whether the challengers have standing. If the answer is yes, then the court’s nine justices must decide whether the FDA’s actions to facilitate access to mifepristone are valid. A decision is expected in June.
Changes made by the agency over the past eight years allowed the drug to be used through 10 weeks of pregnancy, rather than the previous limit of 7 weeks. The changes also relaxed the requirement that the drug be dispensed in person, allowing it to be sent through the mail. If the court invalidates those actions, mifepristone access would be restricted nationwide. The Supreme Court reversed Roe v. Wade, the decision legalizing abortion nationally, in 2022.
Eva Temkin, a lawyer specializing in FDA regulatory issues at the law firm Paul Hastings, who is based in Washington DC, notes that the justices seemed particularly skeptical that the plaintiffs had standing. The court didn’t focus much on the appropriateness of the FDA’s actions, she says. “I am very hopeful that the Supreme Court was not immersed in those issues as much because they recognized how outrageous it would be to find the FDA scientific judgment here was not exercised appropriately.”
Reproductive health researchers say that the case has no scientific merit, because mifepristone has proved to be safe and effective. They also say that a ruling against the FDA would undermine the agency’s authority to regulate medicines. Mifepristone, which the FDA approved in 2000, is used in combination with the drug misoprostol to induce abortion. Endorsed by the American College of Obstetricians and Gynecologists, the pairing is the most commonly prescribed regimen for medication abortion in the United States, where 63% of abortions are carried out using pills.
A question of standing
During oral arguments today, justices questioned the anti-abortion group’s allegation that the physicians it represents could be harmed by the widespread access to mifepristone. Emergency room doctors, the group says, might have to treat people who experience complications as a result of a medication-induced abortion. Treating the aftereffects of a therapy to which they have ethical objections would cause emotional suffering and distress, the group says.
“I'm worried that there is a significant mismatch, in this case between the claimed injury and the remedy that's being sought,” said justice Ketanji Brown Jackson at the hearing. “The obvious common-sense remedy would be to provide them with an exemption, that they don't have to participate in this procedure,” she added. Existing federal and state laws already allow health care providers to refuse to perform abortion-related care, noted solicitor general Elizabeth Prelogar, who was representing the US government at the hearing.
“This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule,” said justice Neil Gorsuch.
But some justices expressed sympathy for the anti-abortion group’s arguments. “Maybe what (the FDA) did was perfectly lawful,” said justice Samuel Alito. “But shouldn't somebody be able to challenge that in court?”
Retracted studies
The case started in 2022, when the anti-abortion group filed suit against the FDA claiming that the drug’s approval in 2000 — and subsequent decisions that facilitated access to the drug — had “potentially serious and life-threatening effects on women and girls.”
In 2023, the judge overseeing the case, Matthew Kacsmaryk in the US District Court for the Northern District of Texas ruled in favour of the plaintiffs, invalidating mifepristone’s FDA approval. But the Supreme Court put the ruling on hold, which allowed mifepristone to remain on the market while the case was being appealed.
In his decision, Kacsmaryk relied on problematic studies to question mifepristone’s safety. Two papers1,2 he cited were retracted in February because of problems with study design and methodology and errors in data analysis, among other issues. The prevailing scientific literature3,4 contradicts the papers that Kacsmaryk cited.
Later that year, the US Court of Appeals for the Fifth Circuit ruled that mifepristone should remain an approved drug but invalidated the FDA’s recent actions to make it more accessible. The Supreme Court’s stay on Kacsmaryk’s ruling meant that the Fifth Circuit decision didn’t take effect immediately.
Hanging in the balance
If the Supreme Court decides that the anti-abortion group has no standing, the case might be dismissed, Temkin says. If, however, the high court agrees with the Fifth Circuit judges, the resulting rollback in mifepristone accessibility would especially affect pregnant people who seek abortion care later in their pregnancy and those who have difficulty attending an in-person appointment with an abortion provider.
The decision could also have implications for drug development in general, Temkin says. The Fifth Circuit called for a cumbersome and unprecedented new standard for drug approval. If the Supreme Court follows that lead, “that would create delays, that would create inefficiencies and costs and would ultimately undermine patient access to scientifically appropriate medicines,” Temkin says.
Such a decision “would have nothing to do with science or medicine or protecting the health of pregnant people,” says Heidi Moseson, an epidemiologist at Ibis Reproductive Health, a global research organization that supports abortion rights, who is based in Oakland, California.
doi: https://doi.org/10.1038/d41586-024-00938-4
This story originally appeared on: Nature - Author:Mariana Lenharo
