Justice Dept. Asks Supreme Court to Hear Abortion Pill Case

The Justice Department asked the Supreme Court on Friday evening to hear a challenge to the availability of a commonly used abortion pill, mifepristone, raising the possibility that the justices will rule on the fate of the drug.

The move sets up a showdown over access to the pill, which is used in more than half of all pregnancy terminations in the United States, and would bring the issue of abortion back to the court more than a year after the justices eliminated the constitutional right to it. The case could also have implications for the pharmaceutical industry, including the Food and Drug Administration’s regulatory authority over other medications.

The request came in response to a ruling by a federal appeals court last month that upheld the legality of the pill but imposed significant restrictions on its distribution. The ruling by a three-judge panel would prevent the drug from being sent through the mail or prescribed by telemedicine.

For now, the pill remains available because the Supreme Court determined in April that access to the drug would remain unchanged until the appeals process finished.

The court, which is likely to act in the coming months, could decline to hear the case, leaving the lower court’s decision in place. Or it could agree to hear the case.

The Justice Department, in its filing, called the appeals court ruling an “unprecedented decision” that “would threaten to severely disrupt the pharmaceutical industry and prevent F.D.A. from fulfilling its statutory responsibilities according to its scientific judgment.”

The department also vouched for the efficacy and safety of the pill, pointing to studies that have shown that “serious adverse events are exceedingly rare.” It argued that losing access to the pill “would be damaging for women and health care providers around the nation.”

“For many patients, mifepristone is the best method to lawfully terminate their early pregnancies,” the government lawyers wrote. “They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy or past trauma.”

The implications for the pharmaceutical industry were vast, government lawyers wrote in the brief, adding that the lower-court decisions in the case “mark the first time any court has restricted access to an F.D.A.-approved drug based on disagreement with F.D.A.’s expert judgment about the conditions required to assure that drug’s safe use — much less done so after those conditions had been in effect for years.”

Danco Laboratories, a manufacturer of mifepristone, filed a similar request on Friday, saying the case was of “indisputable importance” and outlining the wide-ranging reverberations of any decision.

“For the women and teenage girls, health care providers, and states that depend on F.D.A.’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously,” the company wrote. “And for the pharmaceutical and biotechnology industry, permitting judicial second-guessing of F.D.A.’s scientific evaluations of data will have a wildly destabilizing effect.”

Danco added that the case sought to limit access to abortion rather than determine the safety of a drug approved more than two decades ago. The company argued that the lower court had moved to limit access to the drug “at the request of a group of plaintiffs who do not prescribe or use the drug and whose real disagreement with F.D.A. is that they oppose all forms of abortion.”

The case arose from a lawsuit filed in federal court in Amarillo, Texas, months after the Supreme Court overturned Roe v. Wade in June 2022. The plaintiffs, a coalition of four doctors and a group opposed to abortion, asked a federal judge to overturn the F.D.A.’s approval of the drug more than two decades ago. The pill is the first in a two-drug regimen for terminating a pregnancy.

In March, Judge Matthew J. Kacsmaryk of the Northern District of Texas, a Trump appointee known for his anti-abortion views, issued a preliminary ruling that said the F.D.A.’s approval of the drug should be suspended, removing mifepristone from the market.

The Biden administration asked the Supreme Court to intervene, and the court ordered that mifepristone would remain widely available until the appeals process concluded.

Pam Belluck contributed reporting.