*Correction appended. Editor’s note: This article has been updated throughout.
In its first major abortion case since overturning Roe v. Wade, the Supreme Court will hear arguments Tuesday over whether to restrict access to a drug called mifepristone, one of two medications commonly used to induce an abortion.
The case, Food and Drug Administration (FDA) vs Alliance for Hippocratic Medicine, addresses a question ostensibly narrow in scope: whether the federal agency erred in its 2016 decision to expand the circumstances in which mifepristone can be used, expanding its approval from seven weeks of pregnancy to 10 and removing a requirement that it be dispensed in person.
Still, the case has sparked alarm among pharmaceutical manufacturers, who worry that a ruling against the FDA could destabilize the drug industry at large. A ruling against the government could also undercut access to mifepristone for people who have few other options to terminate a pregnancy.
How did all this start?
The case before the Supreme Court was originally filed in Amarillo, Texas. The Alliance for Hippocratic Medicine, a collection of anti-abortion doctors, initially argued for something much broader: They asked the courts to reverse mifepristone’s approval entirely, taking it off the market. They argued that the FDA had not sufficiently considered the drug’s risks, and that the agency had rushed to bring it to market.
That would have been a step without precedent. The FDA is known for its rigorous drug evaluation processes. No court has ever stepped in to undo an FDA approval, although in the past the agency has reversed its own decisions.
Mifepristone was approved for use in the United States in 2000 — more than two decades ago — after a years-long government approval process, and well after it was available in other countries. Years of research shows that when combined with the drug misoprostol, it is very effective and safe in terminating a pregnancy.
The federal judge who heard the case in Texas, Matthew Kacsmaryk, held in April 2023 that the drug’s approval should be blocked while the legal challenge plays out. But that decision was in turn blocked by the Supreme Court and never took effect. That August, the conservative U.S. Court of Appeals for the Fifth Circuit found that undoing mifepristone’s approval entirely would likely violate a federal statute of limitations.
But that court, too, ruled in favor of limiting mifepristone’s reach, attempting to block a 2016 FDA move that expanded the circumstances in which the drug could be used. In that decision, the government agency approved use of the drug for the first 10 weeks of pregnancy, rather than just the first seven. It also removed a requirement that the drug be dispensed in person, and that patients make three separate visits to a health provider. Those changes were based on new medical evidence, and they opened the door to telehealth abortion care.
The ruling blocking those changes has also not taken effect, pending a ruling from the high court.
In December, the Supreme Court agreed to weigh in on the specific question of the 2016 approval — whether the federal agency erred in loosening restrictions on mifepristone. Its decision could affect the drug’s availability not just in states where abortion is banned, but across the country.
Correction: An earlier version of this article was wrong.