A majority of the Supreme Court appeared deeply skeptical of efforts to severely curtail access to a widely used abortion pill, calling into question whether a group of anti-abortion doctors and organizations had a right to challenge the Food and Drug Administration’s approval of the medication.
Over nearly two hours of argument, justices across the ideological spectrum seemed likely to side with the federal government, with only two justices, the conservatives Samuel A. Alito Jr. and, possibly, Clarence Thomas, appearing to favor limits on the distribution of the pill.
Describing the case as an effort by “a handful of individuals,” Justice Neil M. Gorsuch raised whether it would stand as “a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an F.D.A. rule or any other federal government action.”
The challenge involves mifepristone, a drug approved by the F.D.A. more than two decades ago that is used in nearly two-thirds of abortions in the country. At issue is whether the agency acted appropriately in expanding access to the drug in 2016 and again in 2021 by allowing doctors to prescribe it through telemedicine and to send the pills by mail.
The Biden administration had asked the Supreme Court to intervene after a three-judge panel of a federal appeals court favored curbing distribution of the drug. Until the justices decide, access to mifepristone remains unchanged, delaying the potential for abrupt limits on its availability.
Even if the court preserves full access to mifepristone, the pills will remain illegal in more than a dozen states that have enacted near-total abortion bans. Those bans do not distinguish between medication and surgical abortion.
The case brought the issue of abortion access back to the Supreme Court, even as the conservative majority had claimed that it would cede the question “to the people and their elected representatives.”
Justice Gorsuch’s pointed questioning was echoed by other justices, who asked whether any of the doctors involved in the lawsuit could show an actual injury from the federal government’s approval and regulation of the abortion drug.
In one instance, Justice Elena Kagan asked the lawyer for the anti-abortion groups whom they were relying on to show an actual injury.
“You need a person,” Justice Kagan said. “So who’s your person?”
Although the argument contained detailed descriptions of abortion, including questions about placental tissue and bleeding, the focus on whether the challengers were even entitled to sue suggested that the justices could rule for the F.D.A. without addressing the merits of the case.
Since the decision to overturn Roe v. Wade ended a nationwide right in place for nearly a half-century, abortion pills have increasingly become the center of political and legal fights.
In November 2022, a group of anti-abortion doctors and medical organizations sued the F.D.A., asserting that the agency erred when it approved the drug in 2000.
A federal judge in Texas, Matthew J. Kacsmaryk, had issued a preliminary ruling last spring invalidating the F.D.A.’s approval of the drug. In August, a panel of federal appeals judges in New Orleans limited his ruling, determining that mifepristone should remain legal but imposing significant restrictions on access. Those focused on the F.D.A. decisions about telemedicine and pills by mail.
A ruling for the anti-abortion doctors could have implications for the regulatory authority of the F.D.A., potentially calling into question the agency’s ability to approve and distribute other drugs.
Solicitor General Elizabeth B. Prelogar, arguing for the government, warned of the far-ranging consequences, both for the pharmaceutical industry and for reproductive rights. “It harms the pharmaceutical industry, which is sounding alarm bells in this case and saying that this would destabilize the system for approving and regulating drugs,” she said. “And it harms women who need access to medication abortion under the conditions that F.D.A. determined were safe and effective.”
To bring the legal challenge, the anti-abortion doctors and groups must show that they will suffer concrete harm if the pill remains widely available. Lawyers call this requirement standing.
The argument zeroed in on the declarations by seven anti-abortion doctors in the lawsuit. They said they have suffered moral injuries from the availability of the abortion pill because they may be forced to treat women who come to emergency rooms suffering complications from the pill, including heavy bleeding.
Whether anti-abortion groups had met this basic threshold took up much of the questioning.
Ms. Prelogar asserted that the claims by the anti-abortion doctors and groups “rest on a long chain of remote contingencies,” with scientific studies showing that medical complications from abortion pills are very rare.
She urged the justices to “put an end to this case.”
Justice Thomas asked Ms. Prelogar who could bring such a lawsuit, if she was correct that the doctors could not show a direct injury.
When Ms. Prelogar demurred, Justice Alito, who wrote the majority opinion in Dobbs v. Jackson Women’s Health Organization, which overturned the constitutional right to abortion, returned to the point.
“Is there anybody who could challenge in court the lawfulness of what the F.D.A. did here in this particular case?” he asked.
“In this particular case, I think the answer is no,” Ms. Prelogar responded.
“Well, that wasn’t my question,” Justice Alito said. “Is there anybody who can do that?”
Ms. Prelogar said there was “a profound mismatch here” between the injury claimed by the doctors — that they would be forced to participate in abortion by treating women who had taken an abortion pill — and the remedy they sought, which was to end access to the drug for everyone.
Jessica L. Ellsworth, the lawyer for Danco Laboratories, a manufacturer of the drug, agreed. The anti-abortion doctors presented revolutionary arguments, she said, by putting forth a new interpretation of standing: These arguments are novel, she said, because “individuals who do not use this product, do not prescribe this product, and have a conscience right not to treat anyone who has taken this product — those individuals want to prevent anyone else from using it in line with F.D.A.’s considered scientific judgment.”
Justice Ketanji Brown Jackson examined the idea that if the justices chipped away at the F.D.A.’s regulatory powers, it may fall to judges to interpret medical research to determine whether a drug is safe.
Justice Jackson asked Ms. Ellsworth whether the possibility of “judges parsing medical and scientific studies” raised concerns.
Ms. Ellsworth said it elicited a wealth of worries, for both Danco and the broader pharmaceutical industry. She said the prospect of curbing the F.D.A.’s regulatory power was “concerning for pharmaceutical companies who do depend on F.D.A.’s gold standard review process to approve their drugs and then to be able to sell their products in line with that considered judgment.”
Erin M. Hawley, the lawyer for the anti-abortion doctors, claimed that her clients suffered harm from the abortion pill and were subjected to acting against their conscience. They were forced to treat women in “life-threatening situations in which the choice for a doctor is either to scrub out and try to find someone else or to treat the woman who’s hemorrhaging on the emergency room table,” she said.
Ms. Hawley, who is married to Josh Hawley, a Republican senator from Missouri who has been involved in anti-abortion legislation, added that in an emergency, “it’s a lot to ask” for “doctors to go up to the top floor and litigate this with the general counsel when the federal government’s telling them they don’t have a conscience protection.”
In her rebuttal, Ms. Prelogar homed in on Ms. Hawley’s argument.
She argued that there was only a slim chance that doctors who oppose abortion would have to treat patients. If those doctors wanted to opt out, they can do so under federal conscience protections, policies that allow doctors and other health workers to opt out of providing care they object to.
The anti-abortion challengers had made generalizations, with no specific example of a doctor who had to provide care against their conscience, Ms. Prelogar said, demonstrating “that the past harm hasn’t happened.”
