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. 

And the case signifies something larger: It’s a first stab by abortion opponents at curbing access nationwide, and resurrecting the Comstock Act, a 19th-century morality law that could be used to outlaw mailing abortion pills, and possibly even some forms of birth control.

Where did this case come from, and what effects could it have? The 19th explains what you need to know.

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.

What is mifepristone?

Mifepristone is one of two drugs used in medication abortions, the most common mechanism to terminate a pregnancy. It is taken with misoprostol, which is typically administered 24 to 48 hours later. 

The two-drug combination is incredibly effective through the first trimester, though patients past 10 weeks may require additional misoprostol. It can also be used for miscarriage management, which is treated through the same regimen. 

Patients taking these medications can experience heavy bleeding and cramping. But the risk of complications is very low, studies have repeatedly found.

Demand for medication abortion has grown in recent years, even more so since Roe v. Wade was overturned, according to the Guttmacher Institute. In 2020, it accounted for 53 percent of abortions. In 2023, it rose to 63 percent — almost two-thirds of all abortions. 

Could the court change how people get abortions?

The question the court is considering — the legitimacy of the FDA’s 2016 mifepristone expansion — could have significant implications in the post-Roe era.

Perhaps the most immediately consequential would be reinstating the in-person requirement for dispensing the drug. That’s because larger shares of patients have begun to receive medication abortions through telemedicine. They have a virtual consultation with a medical provider and then receive pills through the mail to take at home. The practice is medically safe, less time-intensive for providers, and can be easier for patients who live far away from clinics. From June to September 2023, telemedicine accounted for 16 percent of all abortions in the United States. 

As Americans become more familiar with a telemedicine option, abortion researchers expect that figure to grow — unless a court ruling means it’s no longer an option. A decision barring abortion by telemedicine would affect the entire country, including states with laws meant to protect abortion rights. 

If mifepristone cannot be mailed, patients could switch to acquiring the drug in person. Some physicians have said they would consider offering a different regimen by mail, using only the second drug, misoprostol. That option is less effective and more painful than the two-medication combination, but it still works in the vast majority of first trimester abortions. 

How does this case fit into the larger anti-abortion strategy?

Medication abortion has become a major target for abortion opponents seeking to build on Roe’s overturn. 

That’s in part because of the role these pills have played in helping people skirt state-level abortion bans. Some pregnant people have ordered pills to be sent to friends or relatives in states with abortion protections, who have forwarded the medications to them. 

Others have relied on services such as Aid Access, Abuzz and the Massachusetts Medication Abortion Access Project. Health care providers staffing those organizations practice in states with “shield laws,” statutes that direct their governments not to comply with prosecutions stemming from another state’s abortion laws. Relying on that protection, they prescribe and mail medication abortion pills to people who cannot legally get them at home. 

So far, no patients or physicians have been prosecuted for using medication mailed from one state to another. 

Abortion opponents have struggled to put a stop to the practice, despite outlining it as a key legislative priority. But given the judiciary’s conservative tilt – especially the Supreme Court, which has six conservative justices — using the courts to limit access to mifepristone could be more effective.

This case has also emerged as a test of a new legal strategy: resurrecting an 1873 law known as the Comstock Act that prohibits mailing material “intended for producing abortion.” While the law is still on the books, it hasn’t been enforced in decades, falling out of favor even before Roe v. Wade made its anti-abortion provision obsolete.

WIth Roe gone, some abortion opponents have suggested using it to outlaw mailing mifepristone — or anything that abortion clinics might intend to use to provide care. Taken to its natural endpoint, some scholars argue, a resuscitated Comstock Act could be used to facilitate a de facto national abortion ban.

In addition to critiquing the FDA’s approval process, the Alliance for Hippocratic Medicine has argued that the 2016 mifepristone decision must be struck down because of the Comstock Act. It’s the first case in which the Supreme Court will directly hear arguments about this theory — and its first chance in the post-Roe era to weigh in on its merits.

Citing the law, even in a narrow ruling, could begin to build a body of modern legal theory that would lead to national abortion restrictions. “That would set a precedent about how they think Comstock should be applied,” said David Cohen, a professor at Drexel University’s Kline School of Law.

What happens next?

The court could dismiss the case entirely on standing — holding that the anti-abortion challengers haven’t proven that they’ve suffered harm from mifepristone’s availability, so they don’t have the right to sue. That would, in theory, end the case.

The court could also rule against the FDA, moving to limit when and how mifepristone is dispensed. If the decision makes use of the Comstock Act, it would likely open the door to more involved anti-abortion litigation, potentially paving the way for a national prohibition. 

And even if the court ignores the Comstock Act, a reversal of the FDA’s decision could reverberate through the pharmaceutical industry, opening the door to copycat litigation challenging other politically controversial medications like vaccines or forms of birth control.

The court will rule before the end of its current term, likely sometime in mid-June.