The Supreme Court announced on Wednesday that it would decide on the availability of a commonly used abortion pill, the first major case involving abortion on its docket since it overturned the constitutional right to the procedure more than a year ago.
The Biden administration had asked the justices to intervene after a three-judge panel of the United States Court of Appeals for the Fifth Circuit favored curbing distribution of the drug, mifepristone, appearing skeptical of the Food and Drug Administration’s regulation of the pill in recent years. In its ruling, the panel said that the pill would remain legal, but with significant restrictions on patients’ access, including prohibiting the medication from being sent by mail or prescribed by telemedicine.
The move sets up a high-stakes fight over the drug that could sharply curtail access to the medication, even in states where abortion remains legal. It could also have implications for the regulatory authority of the Food and Drug Administration, which approved the pill more than two decades ago.
The Supreme Court is now in the unusual position of ruling on abortion access even after its conservative majority declared that it would leave that question to elected officials. Until the court issues a decision, the F.D.A.’s approval of the drug remains in place, delaying the potential for abrupt limits on a medication that is used in more than half of all pregnancy terminations in the United States.
The Supreme Court did not set a date for argument but is expected to issue a decision by the end of its term, in late June. That means a ruling could arrive at the heart of the campaign season, during which abortion is expected to be a centerpiece of Democratic platforms.
Abortion rights groups welcomed the court’s decision to hear the case.
“The stakes are enormous in post-Roe America,” Nancy Northup, the president and chief executive of the Center for Reproductive Rights, a legal advocacy organization, said in a statement.
Alliance Defending Freedom, the group that is representing those challenging the F.D.A.’s authority, said in a statement that the court would help settle whether “the F.D.A. has harmed the health of women and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen.”
Since the Supreme Court overturned Roe v. Wade in June 2022, the battle over abortion has largely played out in the states, where it remains a potent political and legal issue.
More than a dozen states have enacted bans or restrictions, and Democrats have seized on the fallout from the ruling to galvanize voters at the polls, even in conservative-leaning states. In Texas, a woman sought an emergency court order to receive an abortion but ultimately was denied by the state’s Supreme Court and left the state to undergo the procedure. And in Ohio, voters in November soundly approved a ballot measure that enshrined a right to abortion in its constitution. The success of similar campaigns has inspired efforts in Arizona, Florida, Nevada and Pennsylvania.
The justices had discussed the case at their Friday conference, the private meeting among the nine. They will hear two consolidated cases challenging more recent changes the F.D.A. made starting in 2016 to expand distribution of the drug, F.D.A. v. Alliance for Hippocratic Medicine, No. 23-235, and Danco Laboratories v. Alliance for Hippocratic Medicine, No. 23-236.
In asking the Supreme Court to hear the case, lawyers for the Justice Department described the ruling by the appeals court as unprecedented in questioning the expert judgment of the F.D.A. Such a decision, they added, “would threaten to severely disrupt the pharmaceutical industry and prevent F.D.A. from fulfilling its statutory responsibilities according to its scientific judgment.”
Alliance Defending Freedom, a conservative Christian legal advocacy organization that has brought cases for clients opposed to abortion and gay and transgender rights, represents the challengers. In a brief, lawyers for the group argued that the Supreme Court did not need to weigh in, calling the appeals court decision a “modest decision” that “merely restores the common-sense safeguards under which millions of women have taken chemical abortion drugs.”
The tangled showdown over the future of the pill reflects how medication abortion has become the next major battlefront for conservative groups.
The case began in November last year, when an umbrella group of anti-abortion medical organizations and a few doctors filed a lawsuit describing the F.D.A.’s approval as flawed and questioning the safety of the drug.
Many studies of mifepristone have found it to be highly safe and effective, and years of research have shown that serious complications are rare. Fewer than 1 percent of patients need hospitalization, medical experts have said.
The drug, the first in a two-part regimen, has been used by more than five million people in the United States and is approved for use in dozens of countries. Under the current F.D.A. regulatory framework for mifepristone, it has been regulated more strictly and studied more strenuously than most other drugs.
The group filed its challenge in the Panhandle city of Amarillo, Texas, where only one federal judge hears civil lawsuits filed there, Judge Matthew J. Kacsmaryk, a Trump appointee who is a longtime opponent of abortion.
In April, Judge Kacsmaryk issued a preliminary ruling invalidating the F.D.A.’s approval of the drug. Days later, a panel of three judges in the Fifth Circuit, based in New Orleans, struck down part of his ruling, allowing the drug to remain on the market but with restrictions.
The Justice Department was among those that sought emergency relief from the Supreme Court, which temporarily paused any changes to the drug’s availability as an appeal made its way up through the lower courts.
A different three-judge panel in the Fifth Circuit ruled in August that the F.D.A.’s original approval of mifepristone should remain in place, as should its approval of a generic version in 2019.
But it rolled back regulations governing the pill, to before 2016. In the years since, the agency made changes that broadened access to the drug. Under those pre-2016 rules, mifepristone must be prescribed only by a doctor and picked up in person. Patients also had to visit a doctor three times during the abortion process.