Mifepristone, the FDA and the Supreme Court Case Thrown Out for Standing

On June 13, 2024, the Supreme Court released its decision in FDA v. Alliance for Hippocratic Medicine, the case that could have pulled the country's most common abortion method off the market or sharply restricted it. Anyone who sat down expecting a sweeping statement about abortion pills found something else entirely. The opinion was unanimous, nine to nothing. It was written by Justice Brett Kavanaugh, who had joined the majority overruling Roe two years earlier. And it did not decide whether mifepristone is safe, whether the FDA acted lawfully, or anything else about the drug. It decided that the people who brought the case had no right to be in court. A fight that had consumed the abortion world for nearly two years ended, for the moment, on a doctrine most people had never heard of.

In short: In 2024 the Supreme Court unanimously threw out a challenge to the FDA's rules for mifepristone because the doctors and groups who sued had not shown they were harmed by those rules. That ruling preserved access but decided nothing about the drug's safety or the FDA's process, and states quickly stepped in to keep the challenge alive.

How a drug approved in 2000 ended up in Amarillo

Mifepristone was approved by the Food and Drug Administration in September 2000, after years of testing in the United States and use in France. It is used together with a second drug, misoprostol, to end an early pregnancy. Over the following two decades the FDA adjusted the rules for prescribing it. In 2016 the agency extended its approved use from seven weeks of pregnancy to ten, reduced the number of required in-person visits, and allowed some health care providers who are not physicians to prescribe it. In 2021, during the pandemic, it stopped enforcing the requirement that the drug be dispensed in person, and in early 2023 it formally dropped that requirement, which allowed the pills to be prescribed through telehealth and sent by mail, and to be dispensed by certified pharmacies.

In November 2022, a coalition of anti-abortion medical organizations and individual doctors sued the FDA. The lead plaintiff, the Alliance for Hippocratic Medicine, had been formed shortly before, and the suit was filed in Amarillo, Texas. Federal courts in Texas are divided into divisions, and in Amarillo nearly every civil case was assigned to one judge, Matthew Kacsmaryk, a Trump appointee who had worked for a conservative religious-liberty legal group before he joined the bench. Choosing a courthouse where you know which judge you will draw is called judge shopping. Lawyers on all sides do versions of it. This case became the most prominent example.

The ruling that shocked even the FDA's critics

In April 2023, Judge Kacsmaryk issued an order that suspended the FDA's original 2000 approval of mifepristone. It was the first time anyone could remember a federal court overriding the FDA's scientific approval of a drug in this way. His opinion relied in part on studies that were later retracted by their publisher in 2024 over concerns about methodology and undisclosed conflicts of interest.

The Fifth Circuit Court of Appeals narrowed the order. It left the 2000 approval in place, reasoning that challenges to it came too late, but would have rolled back the 2016 and 2021 changes, which would have limited the drug to seven weeks, required in-person dispensing, and blocked telehealth prescribing. The Supreme Court put the entire ruling on hold in April 2023 while the appeal continued, so the drug stayed available on its existing terms throughout the litigation.

By the time the case reached the Court for full argument in March 2024, the question was only about the 2016 and 2021 changes. The original approval was no longer at issue.

Two judges, two states, one afternoon

There is a detail from April 7, 2023, that shows how strange this litigation got. The same afternoon Judge Kacsmaryk suspended the drug's approval in Amarillo, a federal judge in Spokane, Washington, Thomas Rice, issued a ruling in a separate case brought by a group of Democratic-led states. That order directed the FDA not to change the availability of mifepristone in the states that had sued.

For a few hours, then, the country had one federal court ordering the FDA to pull back the drug's approval and another ordering the agency to keep it available in much of the country. The FDA was caught between them. The conflict was one reason the Supreme Court stepped in quickly to pause the Texas ruling while the appeals went forward.

The episode also fed a broader argument about how much power a single district judge should have over national policy. Judges appointed by presidents of both parties have issued nationwide orders against administrations they disagreed with, and both parties have complained loudly when the other side did it. In 2024 the federal judiciary's policymaking body, the Judicial Conference, issued guidance encouraging district courts to assign cases seeking statewide or nationwide relief randomly across the district rather than to the single judge in a small division. The guidance was not binding, and the Northern District of Texas, which includes Amarillo, declined to adopt it. In 2025 the Supreme Court, in a separate case about birthright citizenship, sharply limited universal injunctions, although that ruling left other routes for broad relief open.

Here's the fair point for progressives: a rule that lets one judge in Amarillo block a medicine nationwide also lets one judge in a liberal district block a policy you oppose. Reforms to judge shopping should be judged by whether they are fair to both sides, not by which side used the tactic last.

What standing is, and why it decided everything

Standing is a rule about who gets to sue. The Constitution gives federal courts power to decide "cases" and "controversies," and the Supreme Court has long read that to require a plaintiff to show three things: a concrete injury, caused by the defendant, that a court can fix. Without that, a federal court has no power to decide the merits, however important the question.

The plaintiffs in this case were doctors who do not prescribe mifepristone and do not perform abortions. Their theory of injury was indirect. They argued that the FDA's looser rules meant more women would take the pills, that some of those women would suffer complications, that some would go to emergency rooms, and that the plaintiff doctors might then have to treat them, possibly in ways that would violate their consciences or divert their time.

Justice Kavanaugh's opinion rejected that chain. The doctors had not shown that any of them had been or would be forced to participate in an abortion against their consciences. Federal conscience laws already protect doctors from being required to provide or assist in abortions, and the government confirmed in the case that those protections apply in emergency rooms. The fact that the doctors strongly object to the FDA's decisions does not, by itself, give them a right to sue. A citizen's objection to a policy, however sincere, is not an injury of the kind courts can address. If it were, Kavanaugh noted, almost anyone could challenge almost any government action.

The associations that sued on behalf of their members failed for the same reason: an organization's standing depends on its members', and the members had not shown injury. An organization cannot create its own standing simply by spending money to oppose a policy.

Justice Clarence Thomas wrote a concurrence agreeing with the result and suggesting the Court should reconsider the whole doctrine that lets associations sue on behalf of their members. That idea would cut against lawsuits brought by groups across the political spectrum, including many progressive organizations.

Who else stood beside the FDA

The government was not the only defendant. Danco Laboratories, the company that sells the brand-name version of mifepristone in the United States, joined the case to defend its product, and it argued alongside the Justice Department at the Supreme Court. A second company, GenBioPro, which makes the generic version the FDA approved in 2019, was not a party but had obvious stakes.

The drug industry more broadly took notice. Pharmaceutical executives and investors filed briefs warning that if a court could suspend an FDA approval decades after the fact, on the say-so of plaintiffs who did not use the drug, every approval would become uncertain. A company considering years of expensive trials would have to price in the risk that a single judge somewhere might undo the result. That argument had nothing to do with abortion, and it helped explain why the case drew attention from people who rarely comment on it.

It is worth remembering when people describe these fights as purely ideological. The FDA's authority to make scientific judgments that courts respect is part of how medicines of every kind reach patients, and a ruling against it would have reached far beyond one drug.

The fair case for the plaintiffs, and why it failed

Opponents of the FDA's changes made an argument that deserves a fair statement. They said the agency had loosened restrictions in 2016 and 2021 without adequate study, removed requirements for reporting non-fatal complications, and allowed the drug to be dispensed without an in-person exam that could rule out ectopic pregnancy or confirm gestational age. They believed the agency had prioritized access over caution. Those are policy arguments about how a drug should be regulated, and people may hold them in good faith.

The problem was the venue. A federal court is not the place to relitigate a scientific agency's policy judgment simply because a group disagrees with it. Congress gave the FDA that job, along with the tools to monitor drug safety after approval. A doctor who does not prescribe a drug, does not want to, and is protected by law from being forced to cannot ask a court to undo the drug's rules on the ground that someone else's patient might someday show up in the emergency department. That is the logic of standing, and it is also why the ruling drew no dissents.

What the decision did not do

Because the case ended on standing, the Court said nothing about whether the FDA's 2016 and 2021 decisions were lawful or about mifepristone's safety. Those questions were left for another case with plaintiffs who could show an injury.

That other case started almost immediately. Before the Supreme Court ruled, the states of Missouri, Kansas and Idaho had asked to join the Amarillo case. States can sometimes show standing in ways that individual doctors cannot, for example by pointing to costs to their Medicaid programs or to their own laws restricting abortion. After the Supreme Court's decision, the states moved to carry the challenge forward in the same courtroom.

Other fights followed. Some states have tried to classify mifepristone and misoprostol as controlled substances. Louisiana did so in 2024. The federal administration has also signaled interest in reviewing the drug's safety and labeling. Because the status of these efforts keeps changing, the best place to check where any particular challenge stands is Court Watch and the pill-specific topic page listed below.

What progressives should take from a win on a technicality

It is tempting to read a 9 to 0 ruling as a decisive victory. I think that is a mistake, and an understandable one.

The ruling was a real win: millions of people continued to get a safe medication through the channels the FDA had approved. But the reasoning protected the drug only against these particular plaintiffs. It did not shield the FDA's scientific judgment from the next challenge, and it did not prevent a future administration from changing the drug's rules through its own process. In some ways, the safest home for medication abortion access is now neither the courts nor the FDA alone but the states that have written protections into their own law, plus the doctors and pharmacies operating under them.

There is also something worth noticing about who wrote the opinion. A justice who voted to overrule Roe wrote a unanimous ruling preserving access to abortion pills, and he wrote it in a way that spoke directly to the doctors who sued, assuring them that federal law already protected their consciences. Courts follow rules of procedure that sometimes cut against the outcome a judge might prefer. That is not a reason to trust any particular bench. It is a reason to understand the rules well enough to use them.

What you can do

Mifepristone's fate now turns on state lawsuits, agency decisions and state laws. You can follow each and weigh in where it counts.

• Track the pill cases. The abortion pills and mifepristone page gathers reporting on the state challenges, the FDA's actions and new state laws, so you can see which threats are active.
• Comment when the agency asks. If the FDA proposes changes to how mifepristone is labeled or dispensed, the proposal will appear on the public comment page, which lists open federal rules by issue with the soonest deadlines first and explains how to write a comment the agency has to consider.
• Press your state legislators. Use the representatives lookup to reach the lawmakers who decide whether your state protects access to medication abortion, and see their recent votes before you call.
• Support legal and medical groups doing the work. The organizations directory lists health and legal aid nonprofits in every state, including those that help patients understand what is lawful where they live.