Mifepristone is one of two drugs used to provide medication abortions, which account for over half of all abortions in the United States. The U.S. Food and Drug Administration approved mifepristone (also known as RU-486 and its brand name, Mifeprex) in 2000, and since then more than five million people in the United States have used it for medication abortion and miscarriage management. Mifepristone is overwhelmingly safe and has been rigorously tested; its rate of adverse reactions is lower than that of both Tylenol and Viagra.
Yet a newly formed antiabortion organization called the Alliance for Hippocratic Medicine, represented by the anti-church-state-separation group Alliance Defending Freedom, challenged the FDA’s approval of mifepristone in a case brought in the U.S. District Court for the Northern District of Texas. On Friday, April 7, Judge Matthew Kacsmaryk (a former lawyer for another anti-separationist group and longtime antiabortion advocate) issued an unprecedented 67-page ruling purporting to overturn the FDA’s approval and to take mifepristone off the market. The ruling relied heavily on flawed reasoning and faulty science, as well as religiously motivated nineteenth-century legislation known as the Comstock Act. Anticipating that the FDA would immediately appeal the decision, Judge Kacsmaryk ruled that his decision would not take effect until a week after its issuance.
On Monday, April 10, the FDA appealed Judge Kacsmaryk’s decision to the U.S. Court of Appeals for the Fifth Circuit and asked the court to stay the lower court’s ruling to preserve mifepristone access in the meantime.
Late in the evening of Wednesday, April 12, the Fifth Circuit partially granted the FDA’s request, allowing mifepristone access for the first seven weeks of pregnancy (down from the FDA’s current approval for use until ten weeks) and requiring in-person visits (blocking the FDA’s approval of mifepristone by mail). Seeking to preserve full access to mifepristone and prevent any of Judge Kacsmaryk’s ruling from going into effect, the Biden administration requested emergency relief from the U.S. Supreme Court on Friday, April 14.
That same day, Americans United joined more than 200 reproductive health, rights, and justice organizations in an amicus brief supporting the FDA’s request for a stay of the lower courts’ decisions, so that mifepristone access could be preserved while the full appeal proceeds in the Fifth Circuit. The Supreme Court granted that stay on April 21, 2023.
On May 1, 2023, Americans United joined more than 200 reproductive health, rights, and justice organizations in an amicus brief arguing that the district court’s opinion should be fully reversed.
On August 16, 2023, the Fifth Circuit vacated in part and affirmed in part the district court’s decision. The Fifth Circuit vacated the district court’s ruling as to the approval process, leaving in place the FDA’s 2000 approval of mifepristone and its 2019 approval of a generic version of the drug. But the court affirmed a ruling by the district court to restore burdensome restrictions on the medication that existed prior to 2016, when the FDA commenced expanding access to the medication.
Because of the Supreme Court’s April 21 decision, the Fifth Circuit’s ruling has been put on hold. On September 8, 2023, the U.S. Department of Justice filed a petition asking the U.S. Supreme Court to review the Fifth Circuit’s August 16 ruling reinstating pre-2016 restrictions on mifepristone. The Supreme Court agreed to review the Fifth Circuit’s decision on December 13, 2023.
On January 30, 2024, Americans United, along with 236 allied groups, filed an amicus brief in the Supreme Court. The brief stresses that more than 20 years of evidence supports the FDA’s conclusion that medication abortion with mifepristone is safe and effective. The brief further argues that the Fifth Circuit’s unprecedented decision to severely restrict access to mifepristone imperils the health and safety of millions of people.
On June 13, 2024, the Supreme Court ruled that the plaintiffs lacked standing—the legal right to sue—to challenge the FDA’s approval and regulation of mifepristone. The Court’s decision means that the plaintiffs’ lawsuit fails and mifepristone will remain accessible, at least for now.
