The Justice Department on Friday evening asked the Supreme Court to hear a challenge to the availability of a commonly used abortion pill, mifepristone, raising the possibility that judges will rule on the drug’s fate.
The decision sparks 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 abortion issue back to court more than a year after the judges eliminated this constitutional right. to that. The case could also have implications for the pharmaceutical industry, including the Food and Drug Administration’s regulatory authority over other drugs.
The request follows a ruling last month by a federal appeals court that upheld the legality of the pill but placed significant restrictions on its distribution. The decision of a panel of three judges would prevent the drug from being sent by mail or prescribed by telemedicine.
For now, the pill remains available as the Supreme Court determined in April that access to the drug would remain unchanged until the appeal process is completed.
The court, which is expected to rule in the coming months, could decline to hear the case, leaving the lower court’s decision in effect. Or he might agree to hear the case.
The Justice Department, in its filing, called the appeals court’s decision an “unprecedented decision” that “would threaten to seriously disrupt the pharmaceutical industry and prevent the FDA from fulfilling its statutory responsibilities under its scientific judgement.
The department also vouched for the pill’s effectiveness and safety, pointing to studies that showed “serious adverse events are extremely rare”. He argued that losing access to the pill “would be detrimental to women and health care providers across the country.”
“For many patients, mifepristone is the best method of legally terminating their early pregnancy,” the government lawyers wrote. “They may choose mifepristone over surgical abortion due to medical necessity, a desire for intimacy, or past trauma.”
The implications for the pharmaceutical industry were wide-ranging, government lawyers wrote in the brief, adding that the lower court rulings in the case “mark the first time a court has restricted access to an FDA-approved drug.” on the basis of disagreeing with the expert judgment of the FDA on the conditions required to ensure the safe use of this drug – let alone after those conditions have been in effect for years.
Danco Laboratories, a maker of mifepristone, filed a similar request on Friday, saying the case was of “unquestionable importance” and pointing out the broad repercussions of any decision.
“For women and adolescent girls, health care providers, and states who depend on the actions of the FDA to ensure the availability of safe and effective reproductive health care, this case is extremely important,” the company wrote. “And for the pharmaceutical and biotech industry, allowing a judicial challenge to the scientific assessments of the data by the FDA will be extremely destabilizing.”
Danco added that the case is about limiting access to abortion rather than determining the safety of a drug approved more than two decades ago. The company argued that the lower court decided 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 the FDA is that they are s ‘oppose all forms of abortion’.
The case follows 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 an anti-abortion group, asked a federal judge to overturn the drug’s FDA approval more than two decades ago. The pill is the first of a dual therapy intended to terminate a pregnancy.
In March, Judge Matthew J. Kacsmaryk of the Northern District of Texas, appointed by Trump and known for his anti-abortion views, issued a preliminary ruling that the drug’s FDA approval should be suspended, thereby withdrawing mifepristone. of the market.
The Biden administration asked the Supreme Court to intervene, and the court ordered that mifepristone would remain widely available until the appeal process was completed.
Pam Belluck contributed reports.