Supreme Court upholds FDA approval of mifepristone
The U.S. Supreme Court unanimously ruled on June 13, 2024, that the FDA's approval of the abortion pill mifepristone is valid and remains in effect. The decision dismissed challenges from anti-abortion groups, affirming the agency's regulatory authority. This ruling ensures continued access to medication abortion, which accounts for more than half of U.S. abortions.
In a 9-0 decision, the Supreme Court sided with the FDA in the case FDA v. Alliance for Hippocratic Medicine. The challengers, a group of anti-abortion doctors and organizations, argued that the FDA improperly approved mifepristone in 2000 and expanded its availability in 2016 and 2021. They sought to restrict or overturn the approval, claiming it posed health risks to women and violated the Comstock Act.
Justice Brett Kavanaugh wrote the majority opinion, stating that the plaintiffs lacked standing to sue because they could not demonstrate direct injury. "Neither the FDA nor any other federal agency is responsible for enforcing the distribution and administration of mifepristone," Kavanaugh wrote. He emphasized that doctors opposed to abortion could simply decline to prescribe it, avoiding any ethical conflict.
The ruling reverses lower court decisions that had temporarily restricted mifepristone access. In April 2023, a Texas federal judge issued a nationwide block on the pill's use, which was partially stayed by the Supreme Court in a 7-2 vote. The 5th U.S. Circuit Court of Appeals then limited the restrictions to the 2016 and 2021 changes, but the Supreme Court's latest decision restores the status quo.
Mifepristone, used in combination with misoprostol, is the first drug in a two-step medication abortion regimen approved by the FDA. According to the Guttmacher Institute, medication abortions made up 63% of all U.S. abortions in 2023. The drug has been deemed safe and effective, with serious complications occurring in less than 0.5% of cases.
Anti-abortion advocates expressed disappointment. "This is not the end of the fight," said Erika Christensen of the Alliance for Hippocratic Medicine. On the other side, advocates for reproductive rights celebrated the outcome. "This is a victory for the rule of law and for the FDA's scientific process," said Mini Timmaraju, president of A Choice for America.
The decision comes amid ongoing legal battles over abortion access following the 2022 overturning of Roe v. Wade. While it preserves nationwide access to mifepristone via mail and telehealth, state-level restrictions continue to vary.