Supreme Court Upholds Access to Abortion Pill Mifepristone During Ongoing Legal Battle

The U.S. Supreme Court on Thursday issued a significant order that preserves women's access to mifepristone, a drug used in the most common method of abortion, while a federal lawsuit challenging its approval and availability continues. The decision blocks lower-court restrictions that would have severely limited how the medication can be prescribed and distributed. As a result, women seeking abortions can continue to obtain mifepristone at pharmacies, through the mail, and without an in-person visit to a doctor—at least until the case moves further through the judicial system, including a potential appeal to the high court later.

Background: The Legal Challenge to Mifepristone

Mifepristone, when used in combination with misoprostol, is the standard regimen for medication abortion—the most common method of ending an early pregnancy in the United States. The U.S. Food and Drug Administration (FDA) first approved the drug in 2000, and over the years has gradually expanded access, including allowing telehealth prescribing and mail delivery. These changes have made abortion more accessible, especially in states with few clinics.

In November 2022, a coalition of anti-abortion medical associations and doctors filed a lawsuit in federal court in Texas, arguing that the FDA overstepped its authority in approving mifepristone and that the drug is unsafe for women. The plaintiffs sought to have the approval revoked or, at minimum, to roll back the FDA's recent relaxations on dispensing requirements, such as the in-person dispensing rule and the ban on mail-order pharmacy distribution.

Lower Court Rulings and the Circuit Split

In April 2023, U.S. District Judge Matthew Kacsmaryk issued a sweeping ruling suspending the FDA's approval of mifepristone nationwide. That decision was immediately appealed. The U.S. Court of Appeals for the 5th Circuit partially stayed the district court's order, but reinstated the pre-2016 FDA restrictions on mifepristone—those that required three in-person clinic visits and prohibited mail delivery of the drug. The 5th Circuit reasoned that the challengers were likely to succeed on their claims regarding the FDA's later changes, but not on the original approval.

The Biden administration and the drug manufacturer Danco Laboratories quickly asked the Supreme Court to intervene, arguing that the 5th Circuit's ruling would cause irreparable harm to women and the healthcare system. The high court initially put the 5th Circuit’s restrictions on hold while it considered the case, and on Thursday issued a final order preserving access pending the outcome of the appeal in the lower courts.

Supreme Court's Order: What It Does and Does Not Do

The Supreme Court's one-paragraph order, issued without noted dissent, grants the government's emergency request to stay the 5th Circuit's ruling. The order means that, for now, mifepristone remains legally available under the current FDA regulations, including dispensing via certified pharmacies and through telehealth consultations without an in-person visit. The justices did not rule on the merits of the case; they only decided to block the lower-court order while the appeal proceeds.

The Court deferred taking up the core legal question—whether the FDA's approval of mifepristone was lawfully granted—and instead sent the case back to the 5th Circuit for further review. This effectively punts a final decision until at least late 2023 or early 2024, meaning access to the pill is likely to remain unchanged through the end of the year and possibly longer, depending on how quickly the appellate court acts and whether the Supreme Court agrees to hear a full appeal.

Implications for Patients, Providers, and the Law

The Supreme Court's order has immediate practical consequences. Women seeking medication abortions can continue to obtain mifepristone by mail or from a pharmacy after a telehealth appointment, without having to travel to a clinic. This is especially important for those living in abortion-hostile states where clinics have closed, though those women may still face state-level restrictions that ban abortion altogether. The drug remains available in states where abortion is legal, but the ruling does not change state laws that regulate abortion.

• For patients: The current, more flexible access to mifepristone continues, removing the barrier of an in-person visit and reducing travel burdens.
• For providers: Prescribers can continue to rely on telehealth and pharmacy dispensing without fear of federal enforcement, pending further court action.
• For the pharmaceutical industry: The case raises concerns about judicial interference in FDA scientific decisions, which could affect drug regulation beyond abortion.

Legal experts note that the Supreme Court's decision does not address the standing of the anti-abortion groups to challenge FDA approval—an issue that could be key in the final outcome. The Biden administration has argued that the plaintiffs lack legal standing because they cannot show they have been harmed by the FDA's decisions. The appeals court has yet to rule on standing, and if the plaintiffs are found to have no right to sue, the entire case could be dismissed.

What’s Next: The Path Forward in the Courts

The case now returns to the 5th Circuit Court of Appeals, where oral arguments are expected in the coming months. That court will consider the merits of the challenge, including whether the FDA properly approved mifepristone and whether its subsequent regulatory changes were lawful. Regardless of the 5th Circuit's ruling, the losing party is almost certain to appeal to the Supreme Court, which could take up the case as early as its 2023–2024 term.

If the high court eventually rules against the FDA, mifepristone could be removed from the market nationwide or subjected to the older, more restrictive rules. Such a decision would severely disrupt abortion access, especially since medication abortion now accounts for more than half of all abortions in the United States. However, the Supreme Court's cautious approach on Thursday suggests that the justices are wary of making a sweeping judgment without a thorough review.

For now, the immediate crisis has been averted, but the legal battle over mifepristone is far from over. The Supreme Court's order buys time for patients, providers, and policymakers to prepare for whatever the ultimate outcome may be.

Related Topics

• Background of the mifepristone lawsuit
• Lower court rulings explained
• Details of the Supreme Court decision
• What happens next in court