For over a year, the legal status of one of the most widely used medications in American reproductive healthcare hung in the balance. The case made its way from a federal courtroom in Texas to the U.S. Supreme Court, with two lower courts issuing directly contradictory rulings along the way. In June 2024, the Supreme Court finally resolved the specific legal challenge in front of it — though, as is often the case with rulings that turn on procedure rather than substance, “resolved” comes with some important caveats.
This piece walks through how the case developed, what the Supreme Court actually decided, and what remains unsettled.
How the Case Began
The legal dispute traces back to November 2022, when an anti-abortion medical association, the Alliance for Hippocratic Medicine (AHM), sued the Food and Drug Administration (FDA) in federal court in Texas. The group argued that the FDA had not followed proper procedures when it approved mifepristone in 2000, and separately challenged changes the agency made in 2016 and 2021 that expanded access to the drug — including allowing it to be prescribed via telehealth and dispensed by mail.
Mifepristone is typically used alongside a second drug, misoprostol, during the first ten weeks of pregnancy. The first drug blocks progesterone, a hormone necessary for a pregnancy to continue; the second, taken a day or two later, induces contractions. Together, this two-drug regimen accounts for a substantial share of abortions in the United States and has been used for induced abortion and miscarriage management since its original FDA approval.
Conflicting Rulings and an Emergency Appeal
In April 2023, a federal judge in Texas, Matthew J. Kacsmaryk, issued a preliminary ruling that would have invalidated the FDA’s original approval of mifepristone nationwide. Almost simultaneously, a federal judge in Washington state, Thomas O. Rice, issued a conflicting ruling in a separate case, ordering the FDA not to restrict the drug’s availability in a number of states that had sued to preserve access.
With two federal courts issuing opposite instructions to the same federal agency, the case was effectively guaranteed to reach a higher court. The Biden administration and the drug’s manufacturer appealed, and the U.S. Court of Appeals for the Fifth Circuit initially allowed mifepristone to remain available while the broader legal questions were litigated. The administration then sought emergency intervention from the Supreme Court, which on April 21, 2023, issued a stay keeping the drug on the market under its existing approval while the case continued through the courts — the moment at which earlier coverage of this case, including this site’s own prior reporting, left off.
What the Supreme Court Actually Decided
The Supreme Court agreed in January 2024 to hear the case directly, with oral arguments held on March 26, 2024. On June 13, 2024, the Court issued its ruling in FDA v. Alliance for Hippocratic Medicine — and it was unanimous, 9-0, in an opinion authored by Justice Brett Kavanaugh.
The ruling turned entirely on a procedural question: standing. Under Article III of the Constitution, a party bringing a federal lawsuit generally has to show it suffered a concrete injury connected to the conduct it’s challenging. The Court held that the Alliance for Hippocratic Medicine and the individual doctors involved had not shown this — none of them prescribed or used mifepristone themselves, and the Court found that their objections, however sincerely held, did not amount to the kind of direct legal injury required to bring the case.
Because the ruling rested on standing, the Supreme Court did not rule on the underlying merits — it never addressed whether the FDA’s original approval process, or its later changes expanding access, were themselves legally proper. The practical effect was to leave the FDA’s current rules in place: mifepristone remains approved, available via telehealth prescription and mail-order pharmacy dispensing, and usable up to ten weeks of pregnancy, exactly as it was before the lawsuit began.
What’s Still Unresolved
This wasn’t necessarily the final word on the underlying legal questions. Three states — Missouri, Idaho, and Kansas — had intervened in the case as plaintiffs and are not subject to the same standing problem that sank the original challenge, since states can sometimes establish standing in ways individual doctors and associations cannot. Litigation from these states has continued in the lower courts since the Supreme Court’s ruling, meaning the broader legal questions about the FDA’s approval and regulation of mifepristone have not been permanently settled, even though the specific 2024 ruling resolved this particular challenge.
Frequently Asked Questions
Did the Supreme Court rule that mifepristone is safe or that its approval was proper?
No. The Court’s ruling addressed only whether the plaintiffs had legal standing to bring the case — it did not reach, and did not rule on, the substantive question of whether the FDA’s approval process was proper.
Is mifepristone still legal and available nationwide?
Following the June 2024 ruling, mifepristone remains available under the FDA’s current rules, including telehealth prescription and mail-order dispensing, in states where abortion itself remains legal. State abortion laws, which vary significantly post-Dobbs, separately affect where and how the drug can be used regardless of its federal approval status.
Could mifepristone’s approval still be challenged again?
Yes. Because the Supreme Court’s ruling was based on standing rather than the merits, a plaintiff able to show the required legal injury — including, potentially, one of the states that intervened in this case — could bring a similar challenge in the future.
What was the original legal argument against mifepristone’s approval?
The plaintiffs argued the FDA had not followed proper regulatory procedure when it originally approved the drug in 2000, and separately challenged the FDA’s 2016 and 2021 decisions that expanded access, including allowing telehealth prescriptions and mail delivery.
Who decided the case, and was it close?
The Supreme Court ruled unanimously, 9-0, in an opinion written by Justice Brett Kavanaugh.
The Bottom Line
The specific legal challenge covered in earlier reporting on this case has been resolved: the Supreme Court unanimously dismissed it in June 2024 on standing grounds, leaving the FDA’s current mifepristone rules in place without ruling on whether the agency’s approval process was itself proper. Related litigation brought by several states continues in the lower courts, meaning the broader legal questions raised by this case may not be fully settled yet, even though this particular challenge has run its course.
