The drug first won FDA approval in 2000, and conditions on its use have been loosened in recent years, including making it available by mail in some states.
WASHINGTON — The Supreme Court is leaving women’s access to a widely used abortion pill untouched until at least Friday, while the justices consider whether to allow restrictions on the drug mifepristone to take effect.
The court is dealing with a new abortion controversy less than a year after its conservative majority overturned Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.
At stake now is whether to allow restrictions on mifepristone ordered by a lower court to take effect while a legal challenge to the medication’s Food and Drug Administration approval continues.
The justices had at first given themselves a Wednesday evening deadline in a fast-moving case from Texas in which abortion opponents are seeking to roll back FDA approval of mifepristone, which is used in the most common method of abortion in the United States.
But on Wednesday afternoon, Justice Samuel Alito issued a one-sentence order giving the court more time and indicating it expects to act by Friday night. Alito, the justice in charge of handling emergency appeals from Texas, provided no explanation.
The justices are scheduled to meet for a private conference Friday, where they could talk about the issue. The additional time could be part of an effort to craft an order that has broad support among the justices. Or one or more justices might be writing a separate opinion, and asked for a couple of extra days.
The drug first won FDA approval in 2000, and conditions on its use have been loosened in recent years, including making it available by mail in states that allow access.
The Biden administration and New York-based Danco Laboratories, the maker of the drug, want the nation’s highest court to reject limits on mifepristone’s use imposed by lower courts, at least as long as the legal case makes it way through the courts. They say women who want the drug and providers who dispense it will face chaos if limits on the drug take effect. Depending on what the justices decide, that could include requiring women to take a higher dosage of the drug than the FDA says is necessary.
Alliance Defending Freedom, representing anti-abortion doctors and medical groups in a challenge to the drug, is defending the rulings in calling on the Supreme Court to restrict access now.
Complicating the situation, a federal judge in Washington has ordered the FDA to preserve access to mifepristone under the current rules in 17 Democratic-led states and the District of Columbia that filed a separate lawsuit.
The Biden administration has said the rulings conflict and create an untenable situation for the FDA.
Even as the abortion landscape changed dramatically in several states, abortion opponents set their sights on medication abortions, which make up more than half of all abortions in the United States.
The abortion opponents filed suit in November in Amarillo, Texas. The legal challenge quickly reached the Supreme Court after a federal judge issued a ruling on April 7 that would revoke FDA approval of mifepristone, one of two drugs used in medication abortions.
Less than a week later, a federal appeals court modified the ruling so that mifepristone would remain available while the case continues, but with limits. The appeals court said the drug should only be approved through seven weeks of pregnancy for now, even though the FDA since 2016 has endorsed its use through 10 weeks of pregnancy.
The court also said that the drug can’t be mailed or dispensed as a generic and that patients who seek it need to make three in-person visits with a doctor, among other things.
The generic version of mifepristone makes up two-thirds of the supply in the United States, its manufacturer, Las Vegas-based GenBioPro Inc., wrote in a court filing that underscored the perils of allowing the restrictions to be put into effect.
In the latest legal twist surrounding the case, GenBioPro filed a lawsuit Wednesday to preemptively block the FDA from removing its drug from the market, in the event that the Supreme Court doesn’t intervene.
The FDA approved the company’s generic pill in 2019, based on data and studies showing it is essentially identical to the original version of mifepristone. Both versions have been studied extensively and deemed safe for women.
If the justices aren’t inclined to block the ruling from taking effect for now, the Democratic administration and Danco have a fallback argument, asking the court to take up the challenge to mifepristone, hear arguments and decide the case by early summer.
The court only rarely takes such a step before at least one appeals court has thoroughly examined the legal issues involved.
The 5th U.S. Circuit Court of Appeals in New Orleans already has ordered an accelerated schedule for hearing the case, with arguments set for May 17.
Mifepristone has been available for use in medication abortions in the United States since the FDA granted approval in 2000. Since then, more than 5 million women have used it, along with another drug, misoprostol, to induce abortions.
