Supreme Court Decides Abortion Pill to Remain Amid Ongoing Legal Battle

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a chemical abortion, are seen at the Women's Reproductive Clinic, in Santa Teresa, N.M., on June 17, 2022. Robyn Beck/AFP/Getty Images

The U.S. Supreme Court decided Friday that mifepristone, an abortion pill, will be broadly accessible amid an ongoing legal battle over its regulatory approval.

Mifepristone, approved in 2000 by the Food and Drug Administration (FDA), is part of a chemical abortion process, and is generally taken with another drug called misoprostol to kill an unborn child in pregnancies up to 10 weeks. It is also sometimes used for women who have miscarriages.

Chemical abortion, also referred to as medication abortion, comprises more than half of total U.S. abortions.

In a brief order, the majority of the Supreme Court justices on Friday granted emergency requests by the Biden administration’s Justice Department and Danco Laboratories, a manufacturer of the drug. The decision puts on hold a preliminary injunction issued on April 7 by a Trump-appointed Texas federal judge, Matthew J. Kacsmaryk, which had frozen the drug’s FDA approval.

Justices Clarence Thomas and Samuel Alito publicly dissented from the decision. In a brief opinion, Alito wrote that the administration and Danco “are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim.” No other justices commented.

Lawsuit Challenges Mifepristone’s FDA Approval

The high court’s latest decision comes in a lawsuit filed in November 2022, challenging the FDA’s approval of mifepristone back in 2000. The Alliance for Hippocratic Medicine and four doctors alleged the approval was flawed and unlawful because it did not adequately review the drug’s safety risks when used by girls under age 18 to terminate a pregnancy.

Prior to the Friday decision, the New Orleans-based 5th U.S. Circuit Court of Appeals on April 12 partially overturned Kacsmaryk’s decision. It decided that mifepristone will remain available nationwide while the case plays out, but with more restrictions, including requiring the woman to make multiple in-person visits to the doctor before she can obtain the abortion pill.

The Supreme Court had faced a self-imposed deadline to act by 11:59 p.m. EDT before the restrictions on access to mifepristone would take effect. Alito, who handles emergency matters in states including Texas, last week issued a temporary pause of Kacsmaryk’s injunction until Wednesday and then extended it two more days, without explanation.

The administration and Danco had told the justices in their filings that access to the drug might be blocked for months if the restrictions were allowed to take effect. They added that the current drug labels would have had to be adjusted, in a process that would have taken months, to account for the restored limits on its use.

Arguments in Legal Case Set for May 17

Mifepristone was sold under the brand name Mifeprex up until 2019, when the FDA approved GenBioPro Inc.’s application for generic mifepristone. The generic version accounts for two-thirds of the mifepristone used in the United States.

GenBioPro on Wednesday filed a lawsuit seeking to preemptively block the FDA from removing its drug from the market amid the ongoing legal challenges, in the event that the Supreme Court doesn’t intervene.

The 5th Circuit Appeals Court has already ordered an accelerated schedule for hearing the case, with arguments set for May 17. The court gave no timetable for a ruling.

Any appeal to the Supreme Court would follow within three months of a ruling, but with no deadline for the justices to decide whether to review the case.

Kacsmaryk’s decision had conflicted with an order also issued on April 7 in a separate case, in which Washington, D.C., had sued alongside 17 other Democrat-governed states to have the FDA preserve access to mifepristone. A federal Obama-appointed judge in the Eastern District of Washington, Thomas Rice, ruled in favor of the request and reiterated his ruling on April 14.