The fate of a commonly used abortion pill is again before the Supreme Court, more than a year and a half after it said it would leave the matter of abortion to elected officials.
The Biden administration had asked the justices to hear a challenge to the drug’s availability after a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit curtailed access to the drug. It had ruled in August that the pill should remain legal in the country but with significant restrictions on patients’ access to it.
That ruling has been temporarily suspended from going into effect while the Supreme Court considers the case.
The battle over the medication could have wide-ranging consequences for access to the drug even in states where abortion is legal, as well as for the Food and Drug Administration’s regulatory authority over other drugs.
Here’s the latest on what is in play.
What’s at stake?
At issue is the availability of mifepristone, the first pill taken in a two-drug regimen for medication abortion that is currently used in nearly two-thirds of all abortions in the United States. More than five million women in the United States have used mifepristone to terminate their pregnancies, and dozens of other countries have approved the drug for use.
After the Supreme Court overturned the right to an abortion in the United States in June 2022, a group of anti-abortion doctors and organizations filed suit against the F.D.A. seeking to invalidate its approval of mifepristone more than two decades ago and to have the pill withdrawn from the market. The plaintiffs claim that mifepristone 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 safe and effective. It has cited a series of studies that show that serious complications are rare. The agency applies a special regulatory framework to mifepristone, meaning that it has been regulated much more strictly and studied more intensively than most other drugs.
What restrictions would limit access to the pill?
The main dispute before the Supreme Court centers on whether changes the F.D.A. made in 2016 and 2021, which significantly broadened access to mifepristone, should remain in effect.
Before those regulation changes, mifepristone had to be prescribed and dispensed only by a specially certified doctor and picked up in person by the patient, who would have to visit the doctor three times during the medication abortion process.
Reinstating the pre-2016 rules would effectively prevent patients from using telemedicine to obtain a prescription and from receiving mifepristone by mail — the way many patients are currently getting access to medication abortion, including patients who live in states with abortion bans. The pre-2016 rules would also prevent other types of certified providers — nurse practitioners, nurse midwives and physician assistants — from prescribing mifepristone, so patients would only be able to obtain the pill from doctors and might have to travel significant distances to do so.
In 2016, the F.D.A. also extended the time frame for mifepristone use during pregnancy, authorizing it until 10 weeks instead of seven weeks.
The decision by the appeals court would technically reinstate that seven-week limit. But it would have less practical impact because physicians in most states can legally use medical discretion to prescribe mifepristone until 12 weeks into pregnancy, the time frame recommended by the World Health Organization, as there is scientific evidence that abortion pills are safe and effective for the patient within that time frame.
How did we get here?
In April, Judge Matthew J. Kacsmaryk of the Northern District of Texas, a Trump appointee who is a longtime opponent of abortion, issued a preliminary ruling invalidating the F.D.A.’s 23-year-old approval of mifepristone. Days later, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit, in New Orleans, struck part of Judge Kacsmaryk’s ruling but affirmed major aspects of it, allowing mifepristone to remain on the market but imposing significant restrictions on it.
Soon afterward, the Justice Department and the company that makes the branded version of mifepristone sought emergency relief from the Supreme Court, which temporarily paused any changes involving mifepristone until another panel of the Fifth Circuit could hear an appeal of Judge Kacsmaryk’s preliminary ruling.
That panel, which included two judges appointed by President Donald J. Trump and one appointed by President George W. Bush, issued its decision in mid-August. The ruling kept in place the F.D.A.’s original approval of mifepristone in 2000, as well as its approval in 2019 of the generic version of the drug, which now accounts for about two-thirds of the mifepristone sold in the United States.
But the appeals court’s decision essentially turned back the clock and said the pre-2016 rules should apply today.
What happens next?
After the justices hear a case, they meet at a private conference in the days that follow, where they cast initial votes. The decision about which justice will write the majority opinion typically goes to the senior justice in the majority. He or she will either opt to do so or assign it to a colleague. Once draft opinions are prepared, including what are likely to be concurring opinions and dissents, they will then circulate those among themselves.
The timeline from oral argument to a decision can vary, but a decision would be expected by this summer.
A ruling by the Supreme Court could preserve full access to mifepristone or impose restrictions, such as mail-order access, but stop short of sharply curtailing access.
If the justices uphold the appeals court ruling, it could also pave the way for all sorts of challenges to the F.D.A.’s approval and regulation of medications. Legal experts said medical providers anywhere in the country might be empowered to challenge government policy that might affect a patient. Leaders of the pharmaceutical and biotechnology industries have filed briefs saying that the case could undermine their businesses by destroying their ability to rely on a single national standard for their products.
Adam Liptak contributed reporting.
