WASHINGTON — The Supreme Court issued a decision on Friday evening that maintained the Food and Drug Administration’s approval of a commonly used abortion pill while an appeal moves forward, after a lower court limited the availability of the drug.
Justice Samuel A. Alito Jr. had paused the lower court’s ruling on the pill, mifepristone, but that freeze had been set to expire at midnight. The justices issued their decision about five hours before the deadline.
When the justices overturned Roe v. Wade in June, the conservative majority said that the legislative branch, not the courts, should make decisions on abortion policy. But the issue quickly made its way back to the Supreme Court, in a case that may have wide-ranging consequences even in states where abortion is legal, as well as for the F.D.A.’s regulatory authority over other drugs.
Here’s what could happen next.
What’s at stake?
At issue is the availability of mifepristone, part of a two-drug regimen that now accounts for more than half of the abortions in the United States. More than five million women have used mifepristone to terminate their pregnancies in the United States, and dozens of other countries have approved the drug for use.
Federal judges have questioned steps the F.D.A. has taken to expand the drug’s distribution, and the U.S. Court of Appeals for the Fifth Circuit, in New Orleans, imposed significant barriers to access last week, even as it said that it would allow the pill to remain on the market.
That decision essentially turned back the clock to 2016, before the F.D.A. added a series of guidelines that eased access to the pill. The restrictions would have included blocking patients from receiving the drug by mail.
Experts say removing the mail option would have significant consequences: Patients would have to take time off work, pay travel costs to get to a medical office and endure the stigma of going out in public to seek an abortion.
The case could also pave the way for all sorts of challenges to the F.D.A.’s approval of medications. Legal experts said medical providers anywhere in the country might be enabled to challenge government policy that might affect a patient, as did the anti-abortion medical coalition that filed the original lawsuit against the pill.
How did we get here?
The dispute traces back to a lawsuit by an umbrella group of medical organizations and a few doctors who oppose abortion, challenging the F.D.A.’s approval of the pill more than two decades ago.
The suit, filed in the Amarillo division of the U.S. District Court for the Northern District of Texas, came before a single federal judge: Matthew J. Kacsmaryk, a Trump appointee who is known as a longtime opponent of abortion.
The plaintiffs have claimed that the pill is unsafe and that the agency’s approval process for the drug was flawed. The F.D.A. has forcefully countered those claims, contending that the drug is very safe and effective. It has cited a series of studies that show that serious complications are unusual and that less than 1 percent of patients need hospitalization.
In his preliminary ruling, Judge Kacsmaryk, the federal judge in Texas, said that the Food and Drug Administration had improperly approved the drug. But he gave the agency a week to seek emergency relief before his ruling would take effect.
The Biden administration immediately appealed, and a divided three-judge panel of the U.S. Court of Appeals for the Fifth Circuit said that mifepristone could remain available as the lawsuit makes its way through the courts.
But in addition to prohibiting sending the pills by mail, the panel blocked health care providers who are not doctors from prescribing them.
What about the Washington State case?
A second case about the abortion pill is proceeding in a federal courtroom in Washington State, after Democratic attorneys general of 17 states and the District of Columbia filed a lawsuit challenging the renewed F.D.A. restrictions on access to mifepristone.
Less than an hour after Judge Kacsmaryk issued his ruling, Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington, an Obama appointee, blocked the agency from curbing the availability of mifepristone in those 17 states and the District of Columbia. Although his order did not affect the entire country, the states in that lawsuit represent a majority of states where abortion remains legal.
Legal experts said the direct conflict between the Washington State case and the Fifth Circuit’s decision to block specific parts of the F.D.A.’s rules for the abortion drug helped ensure the Supreme Court would have to weigh in.
Adam Liptak contributed reporting.