A federal appeals court in New Orleans on Thursday rejected an unprecedented challenge to mifepristone, the FDA-approved abortion medication that has been used by millions of Americans since 2000, handing a victory to the Biden administration and reproductive rights advocates in a case that had threatened to upend decades of medical consensus.
The ruling by the Fifth Circuit Court of Appeals overturned a lower court’s decision in April that had blocked the FDA’s approval of the drug, which, when used in combination with misoprostol, can terminate early pregnancies up to 10 weeks. The decision came just hours after the Supreme Court declined to intervene in the case, leaving the medication’s regulatory status intact for now. The appeals court’s order, issued without explanation, preserved the FDA’s authority to regulate mifepristone under its existing framework, though legal experts warned that the issue could still reach the Supreme Court in a future term.
The case originated in November 2022, when a coalition of antiabortion groups and physicians, led by the Alliance Defending Freedom, filed a lawsuit arguing that the FDA had exceeded its authority in approving mifepristone. The plaintiffs claimed the drug’s approval was based on flawed science and that its use posed unacceptable risks to women. The lawsuit also sought to invalidate the FDA’s 2016 decision to expand access to mifepristone by allowing it to be dispensed through pharmacies and mail order, a change that significantly increased its availability.
Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas granted a preliminary injunction in April, blocking the FDA from defending its approval of mifepristone. His ruling, which was stayed by the Fifth Circuit pending appeal, drew sharp criticism from public health officials and medical associations, who argued that the decision was not grounded in scientific evidence but rather in ideological opposition to abortion.
The FDA had defended its approval of mifepristone, citing decades of clinical trials involving more than 3.5 million patients, which demonstrated its safety and efficacy. The agency also pointed to the drug’s widespread use in other countries, including France, where it has been available since 1988, and its endorsement by the World Health Organization. In a statement following the appeals court’s ruling, FDA Commissioner Robert Califf called the decision “a victory for women’s health and for science.”
Antiabortion advocates, however, framed the case as a test of regulatory overreach, arguing that the FDA had bypassed proper review processes. “This represents not about politics—it’s about following the law and protecting women from experimental drugs,” said Carrie Severino, chief counsel of the Judicial Crisis Network, one of the groups that had intervened in the lawsuit. The Fifth Circuit’s decision does not address the merits of the plaintiffs’ arguments but instead defers to the FDA’s expertise, a stance that aligns with long-standing judicial precedent.
The ruling comes at a moment of heightened political and legal tension over abortion rights in the U.S. Following the Supreme Court’s decision to overturn Roe v. Wade in June 2022, access to abortion has become increasingly restricted in many states, prompting a surge in demand for medication abortion. Mifepristone accounts for the majority of abortion procedures in the U.S. Today, with nearly half of all abortions now performed using the drug, according to data from the Guttmacher Institute.
While the Fifth Circuit’s decision preserves the status quo for mifepristone, legal scholars note that the Supreme Court could still take up the case in the future, particularly if lower courts issue conflicting rulings. The court’s silence on Thursday does not preclude it from revisiting the issue, and antiabortion groups have signaled they will continue to pursue legal challenges. For now, however, the medication remains available nationwide, and patients who rely on it for early pregnancy termination can continue to access it without interruption.
The FDA has not indicated whether it will seek further clarification from the courts or proceed with any changes to mifepristone’s regulatory framework. In the absence of new legal challenges, the agency’s current policies—including the 2016 expansion of access—remain in effect. The next phase of the litigation could hinge on whether the plaintiffs appeal the Fifth Circuit’s decision to the Supreme Court, a move that would force the justices to confront a case with profound implications for both reproductive rights and federal regulatory authority.
