The Supreme Court appeared ready to dismiss a challenge on Tuesday from opponents of the Food and Drug Administration’s (FDA) relaxed requirements for dispensing an abortion drug, used to terminate nearly two-thirds of abortions in the country. That would be a victory for the Biden administration and abortion rights supporters, by keeping current rules in place and allowing access in most of the country to the medication.
The justices heard about 90 minutes of arguments about the federal government regulations since 2016 that made access to the drug mifepristone easier, including access by mail. A majority on the court — including several conservatives — suggested individual doctors and advocacy groups that sued may lack “standing” or a legal right to sue to block nationwide access to the medication. Ruling on that legal threshold could mean the court would not address the broader legal arguments over the level of judicial oversight for federal agency actions, including FDA authority to regulate the safety of medicines.
“Do we have to also entertain your argument that no one else in the world can have this drug or no one else in America should have this drug in order to protect your clients?” and their conscientious objections on dispensing or treating patients seeking abortions or emergency reproductive care, asked Justice Ketanji Brown Jackson.
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama, on March 16, 2022.
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Justice Neil Gorsuch raised concerns over judges who had issued a legal maneuver to block continued access to mifepristone. The Supreme Court for now has allowed the FDA regulations to stay in place pending a final ruling.
“We’ve had, one might call it, a rash of universal injunctions,” said Gorsuch. “And 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.”
But Justice Samuel Alito questioned whether the FDA should have unfettered discretion.
“So your argument is that it doesn’t matter if FDA flagrantly violated the law or didn’t do what it should have done, endanger the health of women,” Alito asked the U.S. Solicitor General Elizabeth Prelogar, defending the agency. “It’s just too bad, and nobody can sue in court?”
Dozens of activists on both sides rallied in front of the court, in what has become a contentious election-year political, social, cultural and health-related debate.
The issues presented come nearly two years after the Supreme Court overturned the nationwide constitutional right to abortion, giving states individual discretion to regulate the procedure.
At the time, the court’s 5-4 conservative majority declared “unelected members of this Court” would not be intervening in the future to “override the democratic process” of legislators and mandate national abortion policy.
New data from the Guttmacher Institute research group says nearly two-thirds of all abortions in the U.S. in 2023 relied on mifepristone.
Abortion rights groups say the drug has been proven safe, and that the court’s decision could negatively impact 40 million women nationwide.
Anti-abortion organizations have countered that the FDA for two decades has unlawfully promoted a nationwide regime of on-demand abortion, in defiance of several state health and safety laws.
Mifepristone is taken along with misoprostol, and the two-drug combination is known as medication abortion or the “abortion pill.” Lower courts concluded the federal agency did not fully consider the potential health risks to women when revising regulations for mifepristone beginning in 2016. Those revisions — last updated in 2023 — include reducing the recommended dose, allowing use of the drug up to 10 weeks of pregnancy (from seven weeks), approving a generic version and permitting it to be mailed (eliminating in-person doctor visits), among other measures.
Major pharmacy chains Walgreens and CVS announced this month they were certified to dispense the abortion drugs under the new rules.
Thirty-six states allow some form of access to mifepristone — 21 states in full and restricted in 15, according to Fox News research. Fourteen states ban abortion completely — including medication abortion — except for narrow exceptions.
Temporary security fences align along a path to the plaza of the U.S. Supreme Court Building in Washington, D.C., on April 19, 2023. (Anna Moneymaker/Getty Images)
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About six million women have used the drug since its approval 24 years ago.
Danco Laboratories, the drug’s manufacturer, had also appealed to the Supreme Court seeking final review on the merits.
Dozens of advocacy groups, members of Congress and coalitions of states on both sides of the issue have filed legal “amicus” briefs in recent weeks.
During oral arguments, the Justice Department told the court it should not be “second guessing” the expertise of FDA officials who had painstakingly looked at mifepristone and found it to be safe. Prelogar said doctors that did not use or even prescribe the pill should be prevented from suing based on their individual conscious “injury.”
Several on the bench seemed supportive of the government’s position.
Justice Amy Coney Barrett questioned affidavits in the lawsuit from several doctors opposing the use of mifepristone, and whether their individualized “harm” was enough to sustain a lawsuit.
“The difficulty, to me, is that the affidavits do read more like conscience objections,” said Barrett. “The conscience objection is strictly to actually participating in the abortion, to end the life of the embryo or fetus. And I don’t read either [doctor filing affidavits] to say that they ever participated in that.”
“I’m worried that there is a significant mismatch in this case between the claimed injury and the remedy that’s being sought,” added Jackson. “And the relief that they’re seeking would dramatically alter the approved conditions of use for mifepristone and affect women all around the nation simply because of this conscience injury.”
A box of mifepristone pills seen at a pharmacy in Tehatta, West Bengal, India, on Aug. 18, 2023. (Soumyabrata Roy/NurPhoto via Getty Images)
The court spent relatively little time on the merits of the case and whether the FDA overstepped its authority by loosening restrictions on mifepristone access.
“The reality is, even if there is some increase in emergency room visits, the question of when that rises to a sufficient safety risk is up to the FDA, correct?” said Justice Sonia Sotomayor, regarding severe medical complications requiring hospitalization.
But Alito questioned how much discretion the FDA and other federal agencies should be afforded.
“The statement was made that no court has ever previously second-guessed the FDA’s judgment about access to a drug,” he said. “It’s never second-guessed that? Do you think the FDA is infallible?”
This will not be the only abortion issue the Supreme Court is confronting this term. The justices next month will hold oral arguments on a challenge to Idaho’s restrictions and whether they violate federal laws requiring hospitals to treat patients in life-threatening crises.
A federal court blocked enforcement of Idaho’s Defense of Life Act — which prohibits abortions unless necessary to save the life of the mother — on the ground that the federal Emergency Medical Treatment and Labor Act preempts it.
The state’s near-total abortion ban establishes criminal penalties for doctors who perform the procedure, except under narrow circumstances.
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But the Biden administration counters that federal law requires emergency rooms to provide “stabilizing care,” including abortions, for a broader range of circumstances than a mother’s life, such as when a patient’s health is in “serious jeopardy.”
Other pending court challenges that may eventually reach the justices include whether the federal Title X family planning program can refer patients for abortions; and whether those whose religious faith supports abortion access can file First Amendment constitutional challenges to state bans.
How ever the court rules on these disputes, the political implications could be immediate and seismic in the November elections. The consolidated mifepristone cases are FDA v. Alliance for Hippocratic Medicine (23-235) and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine (23-236). A ruling is expected by late June.
