Just months after the Supreme Court overturned Roe v. Wade in 2022, a newly-formed group called the Alliance for Hippocratic Medicine sued the Food and Drug Administration, challenging its approval of mifepristone, a medication used for abortion.
On Tuesday, the same justices who undid constitutional protection for abortion will hear arguments in the next frontier of abortion restriction: tightening access across the country for a medication that's used in nearly two-thirds of all abortions nationally.
That is the main issue in FDA v. Alliance for Hippocratic Medicine. On one side are anti-abortion rights physicians and organizations. Originally, they argued that the FDA should not have approved mifepristone in 2000; now they're focusing on the argument that it should not have made it easier to access in 2016 and 2021.
On the other side is FDA and the drugmaker, Danco, who say that the challengers aren't actually harmed by the prescribing rules (and thus don't have standing to bring the case) and that the FDA followed correct procedure and the scientific evidence in making its decisions.
It's a closely-watched case, because the stakes are extremely high – not just for abortion access and reproductive health care, but for the drug industry and even the authority of federal agencies. Here is a summary of what's at stake.
1. It could make medication abortion much harder to get
At least 63% of all abortions last year were medication abortions. They involve taking one dose of mifepristone, which blocks the pregnancy hormone progesterone, and one dose of misoprostol, which causes cramping and empties the uterus. Dozens of studies have found that the combination of these pills is safe and effective for abortion, whether prescribed in a clinic or through telemedicine.
Last August, the Fifth Circuit Court of Appeals ruled that FDA should roll back its prescribing rules to what they were in 2011. That would dramatically cut down on the number of people able to access this medication, for several reasons. It would shut down telemedicine access to the medication and could undo retail pharmacies' new ability to dispense it.
It would also make it only available until seven weeks of pregnancy, instead of 10 weeks under the current rules, along with other changes. (Globally, the medication can be used as late as 12 weeks.)
Even though the difference between seven and 10 weeks might not sound like much, nearly half of medication abortions happen after seven weeks, according to CDC. Melissa Grant, COO of carafem, which runs abortion clinics and provides telemedicine abortions, explains that's because the earliest someone might find out they're pregnant is at four weeks.
A seven-week limit gives people three weeks, at most, "to get a positive pregnancy test, determine what option is best for them, potentially involve people that they care about in their lives, find an appointment, look at potential assistance for the finances of it, and then actually go and get the medication and use it," she says. "That's a rapid turnaround."
Many abortion providers are prepared to switch to another regimen, using only misoprostol, but it requires more doses, which come with more side effects. And Grant says that regimen might be the next target if the challengers succeed in restricting mifepristone. "We wouldn't be surprised if the next move on the political chessboard is to make both of these drugs unavailable," she says.
2. It would hamper miscarriage care
When someone has a miscarriage, doctors often prescribe the same mifepristone plus misoprostol regimen. The treatment can potentially ward off weeks of waiting, worrying and bleeding.
For instance, Michelle Brown told NPR that after she learned she was miscarrying, she was nervous she would start bleeding on her long commute to work in Louisiana, where there was no safe place to pull over. Taking mifepristone allowed her to plan ahead so she could be comfortable at home with her then-fiancé.
Larissa Adams explained to NPR that taking mifepristone allowed her to get through years of family planning challenges that involved miscarriage after miscarriage after miscarriage.
"We use this medication in lots of different ways and for lots of different care," including for miscarriage and pregnancy loss, says Dr. Jamila Perritt, an OB-GYN in Washington D.C. who's the President of Physicians for Reproductive Health. "If this medication is restricted or banned completely, no one will be able to get access to it with any ease," she says.
3. It could affect the whole country, including voters' preferences in blue states
In the nearly two years since the Supreme Court overturned Roe, states have moved in two opposing directions – about half of states ban or seriously restrict abortion, and the other half have passed measures to protect access.
A Supreme Court decision that restricts access to mifepristone would affect the whole country.
"I think there's been to some degree a false sense of security created by ballot initiatives [protecting abortion access] in some states," says Mary Ziegler, a law professor at the University of California-Davis. "People are thinking, 'What happens in the Supreme Court doesn't really matter because I live in California or I live in Michigan or I live in Ohio' – that, essentially, if you voted for a ballot initiative or you live in a blue state, you don't have to worry about it."
"This is a reminder that what happens in the federal courts can override what voters decide," she adds.
4. It could interfere with state sovereignty
A ruling to limit access to mifepristone would extend into the states that have attempted to protect access. That's why a group of 22 Democratic governors filed an amicus brief in this case. It argues that, if successful, the challengers' strategy of using federal courts to override FDA's judgment, "would have an enormously disruptive impact on state governance and hamstring governors' ability to fulfill their mandate of protecting public health and safety in the reproductive health care context and beyond."
Ziegler observes there's an irony here.
"When the Supreme Court overruled Roe, the takeaway, if you will, from Justice Alito, was, 'It's time for this question to be returned to the people and their elected representatives,'" she observes. "And yet, fast forward less than two years later and we have two major abortion cases at the Supreme Court, both of which could very much reconfigure what happens in states." (The other case, from Idaho, challenges federal rules requiring abortion during a medical emergency, regardless of state restrictions.)
6. The drug industry could face destabilizing uncertainty
Drugmakers are quite concerned about the mifepristone case. Hundreds of drug company executives signed a letter last year in support of FDA's authority to regulate medications without judicial interference. Many also submitted an amicus brief.
"This case is about mifepristone right now – it's about one medicine, but it really could be any medicine, " Dr. Amanda Banks, a consultant who signed the amicus brief, said in a press conference this month organized by the ACLU.
"The [FDA] regulatory process that we rely upon as an industry is rigorous and long and it's expensive," she explained, adding that it's not a perfect process, but it's predictable. If it can be undone by plaintiffs who morally object to a medicine and friendly federal courts, that predictability goes out the window, she said.
The uncertainty could affect investors and drug companies and "could put innovation for new drugs and much, much needed therapies for patients, not just in the United States, but globally, at fundamental risk," Banks said.
It could also set a new precedent, Ziegler adds. "Any drug could get a second look from federal judges who are not reviewing as much evidence [as FDA scientists], or are not competent to review as much evidence, because they don't like the way the FDA handled it," she says.
In another amicus brief, former FDA commissioners argued that drug companies could make use a precedent set by this case to challenge a competitor's FDA approval. Or, they write, "organizations representing patients who experience rare adverse events could challenge FDA's risk-benefit analyses and attempt to bar access to safe and effective remedies for others who need them."
"I think that's why the pharmaceutical industry is nervous," Ziegler says. "They're saying, if this could happen with mifepristone, which has a very, very low complication rate and which is very, very well studied because it's been controversial, then what would stop anyone from doing it with every other drug?"
7. A path toward a national abortion ban is embedded in the case
Legal scholars like Ziegler also note that there's an even bigger way that this case could affect everyone in the country. "You have, lurking in the background, the possibility that the Comstock Act is going to be reinvented as an abortion ban," she says.
The Comstock Act is a 19th century law prohibiting the mailing of things for "indecent" or "immoral" use. The plaintiffs in this case use Comstock in one of their arguments, treating it as a straightforward statute and not a defunct law.
The rules included in the Comstock Act could encompass not just abortion pills but birth control and any equipment used for any type of abortion, and Ziegler says this could effectively inhibit all abortion care in the U.S.
Regardless of what the ultimate decision on mifepristone is, "if the court says, 'your reading of the Comstock Act is right,' there are any number of anti-abortion groups that will try to find a way to get back to the Supreme Court to explore all those implications," Ziegler says.
