Mifepristone Ruling: Supreme Court Puts Restrictions on Hold

In a brief order issued Friday evening, the U.S. Supreme Court paused harsh limitations on a key abortion drug while the case plays out in a lower court, leaving access to the medication unchanged for now.

The restrictions, which were set to take effect at midnight, would have had sweeping and detrimental consequences for already-strained abortion access nationwide. The 7-2 Supreme Court ruling, with Justices Samuel Alito and Clarence Thomas dissenting, ensures that the critical drug will remain available until further review by the conservative 5th Circuit Court of Appeals, which plans to hear oral arguments on May 17. Legal experts note the case could make its way back to the Supreme Court in the coming months.

The drug mifepristone — part of the most common method of pregnancy termination in the U.S. — is at the center of an ongoing legal battle between the Biden administration and ideological right-wing judges and advocacy groups who want to see its availability severely diminished.

Reproductive rights advocates expressed satisfaction with the temporary order, but also deep caution. “This is very welcome news, but it’s frightening to think that Americans came within hours of losing access to a medication that is used in most abortions in this country and has been used for decades by millions of people to safely end a pregnancy or treat a miscarriage,” said Jennifer Dalven, director of the American Civil Liberties Union’s Reproductive Freedom Project. “Patients shouldn’t have to monitor Twitter to see whether they can get the care they need. Make no mistake, we aren’t out of the woods by any means. This case, which should have been laughed out of court from the very start, will continue on.”

The legal tug-of-war began when Trump-appointed U.S. District Judge Matthew Kacsmaryk, based in Texas, ruled earlier this month to revoke the U.S. Food and Drug Administration’s approval of mifepristone, the first in a two-step abortion medication regimen taken early in pregnancy. Echoing the arguments of the anti-abortion plaintiffs who filed the suit, Kacsmaryk aggressively questioned the safety of mifepristone, claiming that the FDA rushed approval of the drug.

Those claims have been widely refuted by the medical community: Mifepristone, approved two decades ago, is one of the most studied drugs on the market, with a safety track record similar to ibuprofen and acetaminophen. The risk of serious complications falls below 1 percent. More than 3.7 million women have used the drug since it became available in the U.S., and its use is backed by major medical organizations including the American Medical Association and the American College of Obstetricians and Gynecologists. In his 67-page ruling, Kacsmaryk pulled from dubious anti-abortion sources and employed medically inaccurate and inflammatory rhetoric — including the term “unborn baby” rather than fetus — to make his case.

After an appeal by the U.S. Department of Justice, the 5th Circuit Court of Appeals temporarily blocked Kacsmaryk’s call to suspend FDA approval, but it placed several limitations on the drug that would have rolled back years of FDA progress to widen access to abortion medication. A three-judge panel on the New Orleans-based court sought to impose restrictions that included blocking its use past seven weeks of pregnancy, rather than the FDA-approved 10 weeks; requiring in-person office visits to dispense the drug; and banning its delivery via mail.

Attorneys with the Alliance Defending Freedom, the conservative Christian legal group that represents the plaintiffs, applauded the 5th Circuit’s decision, calling it “a significant victory.” The group has signaled that it hopes the courts revive the long-dormant Comstock Act, an 1873 anti-obscenity law that bars the mail shipment of abortion materials. The zombie law is seen by anti-abortion advocates as a gateway to a nationwide abortion ban through the judiciary.

The Biden administration asked for emergency relief from the Supreme Court, warning that the restrictions would create “profound disruption and grave harm.” Alito — who handles 5th Circuit emergency appeals — paused the ruling from taking effect last Friday and extended the temporary halt until today.

Were they to go into effect, the nationwide limitations sought by the 5th Circuit would have applied even to states where abortion remains legal and pushed abortion care further out of reach for patients in states where the procedure is banned.

The Biden administration and Danco — the brand-name distributor of mifepristone — cautioned that upholding the ruling would throw the drug into regulatory “chaos” and cut off access to the pills for months while Danco re-labeled the drug and obtained other approvals. The 5th Circuit ruling would have forced the FDA to reinstate a “now-obsolete and unfamiliar” regimen that includes higher doses of mifepristone than needed, undercutting the plaintiff’s ostensible concerns about safety. The Justice Department and Danco also warned that the ruling could create a dangerous precedent for other drugs on the market, making them vulnerable to ideologically motivated judicial attacks.

Adding to the growing legal battles over abortion pills, GenBioPro, the generic drug manufacturer of mifepristone, sued the FDA in Maryland federal court on Wednesday to force the regulatory agency to preserve access to the drug, writing that revoking its approval based on a court order would not only be unprecedented, but would also inflict “catastrophic harm” on patients and providers. The manufacturer supplies roughly two-thirds of the drugs sold in the U.S.

The Texas case, known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, has been criticized for “forum shopping.” Kacsmaryk is a longtime anti-abortion advocate, board member of a non-medical Texas crisis pregnancy center, and former attorney with religious-right legal group, the First Liberty Institute. The Alliance for Hippocratic Medicine, the only Texas-based organization that is part of the suit, incorporated itself in the Panhandle city of Amarillo — where Kacsmaryk is in charge of hearing all federal civil cases — just months before challenging the approval of mifepristone, adding to evidence that the plaintiffs cherry-picked a conservative court that would be favorable to their arguments.