This week, the U.S. Supreme Court set a date for one of the highest stakes cases on abortion care this year: accessibility to mifepristone, commonly referred to as “the abortion pill." The Court will start oral arguments for the case U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024.
A ruling in favor of Alliance for Hippocratic Medicine, an organization of anti-abortion activists backed by the Christian right-wing lobbying group Alliance Defending Freedom, who brought the case forward, could result in eliminating access to mifepristone by telehealth and by mail, and shortening the timeframe that it could be used for in a pregnancy from 10 weeks to seven weeks.
The Food and Drug Administration (FDA) approved mifepristone for the medical termination of pregnancy over two decades ago and the drug has a well-established safety profile. But a lawsuit filed in November 2022 alleged that the longstanding approval should be revoked because it was allegedly based on incomplete data. Alliance for Hippocratic Medicine claimed that the FDA failed to protect women when it approved the drug. Hundreds and thousands of researchers and the nations’ leading physicians in numerous amicus briefs have responded by emphasizing there is “ample scientific evidence” to support widespread use and availability of mifepristone.
What many people seemingly forget to mention is that mifepristone is not only used for medication abortions, but it’s also commonly used for early miscarriage management. If the Supreme Court upholds the ruling made by the Fifth Circuit Court of Appeals from last August, patients who need mifepristone in states where abortions are legal will be impacted, experts say.
"This case has serious implications for people in every state in the country."
“Patients who need Mifepristone to complete a miscarriage will suffer,” Julia Kaye, ACLU’s senior staff attorney with the Reproductive Freedom Project, told Salon. “This case has serious implications for people in every state in the country, because even in places where abortion is banned, patients are still relying on this safe and effective medication to help them treat a miscarriage.”
When a person learns they are having a miscarriage, they can proceed with three medical options. First, they can see if the fetus passes on its own. This is called “expectant management,” and it’s a process that can take up to seven weeks. Second, they can have a surgical procedure performed. Or third, they can take medications — mifepristone in combination with another medication called misoprostol — to complete the process and induce the miscarriage faster.
“Mifepristone is an essential tool for people experiencing a miscarriage,” Kaye emphasized. “For people who are desperate for that miserable process to end and not want to have to go through a procedure to empty their uterus.”
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Miscarriages are very common, and an estimated 80 percent of them happen in the first trimester of pregnancy — within the first 12 weeks. A viable pregnancy usually isn’t confirmed until between six to eight weeks of pregnancy. It’s estimated that 70 percent of miscarriages happen when an embryo has the wrong number of chromosomes.
"Mifepristone is an essential tool for people experiencing a miscarriage."
Dr. Michael Belmonte, an ob-gyn and complex family planning subspecialist who’s currently a Darney-Landy Fellow at the American Congress of Obstetricians and Gynecologists (ACOG), told Salon taking mifepristone and misoprostol is a good option for someone who wants to pass the pregnancy at home, too. For example, if someone goes to see their healthcare provider to confirm their pregnancy, but finds out there is no beating cardiac tissue, it’s possible that a missed miscarriage occurred and that the fetus hasn’t developed. It’s a nonviable pregnancy, but has not been physically miscarried.
“Mifepristone and misoprostol is considered the gold standard management,” Belmonte said. “Data shows that you have a higher effectiveness and completion of emptying the uterus and then also this tends to occur in a faster amount of time.”
Minimizing the time of the miscarriage can keep cramping and bleeding from lingering, Belmonte added. In other words, it can shorten an otherwise painful process. It also is more beneficial to use both medications because it's more effective in emptying out the uterus, which lowers the likelihood of a pregnant woman still having to follow-up with a procedure
In 2018, researchers published a study in the New England Journal of Medicine that found using both mifepristone and misoprostol in a two-step process was more effective for managing an early miscarriage than only taking misoprostol. As I’ve previously reported for Salon, restricting access to mifepristone could leave the U.S. to be more dependent on misoprostol for miscarriage management and abortion care. Notably, it’s important to empty the uterus as soon as possible, because retained fetal tissue after a miscarriage can, in rare cases, lead to sepsis.
Then, there’s the impact of restricting providers from eliminating telehealth prescriptions of miscarriage management.
“For some patients, particularly low income patients, people of color and those in rural areas, losing a telehealth option would mean losing access to this essential medication altogether.”
“The beauty of these medications is that it allows someone to really have more control over the miscarriage process and to be able to do this in the privacy and comfort of their own home,” Belmonte said. “And so, really, by not allowing this to be prescribed over telehealth, you're limiting this option to those who can easily access in clinic care, which may push someone to either expectant management." Belmonte said this only makes the process more unpredictable, long and drawn out.
It’s been estimated that over 2.2 million women in the U.S. of childbearing age live in maternity care deserts. Going to a clinic to get mifepristone to complete their miscarriage isn’t an easy option for everyone. “For some patients, particularly low income patients, people of color and those in rural areas, losing a telehealth option would mean losing access to this essential medication altogether,” Kaye said.
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Dr. Amelia Huntsberger, an obstetrician-gynecologist in Oregon, told Salon via email that forcing doctors to offer less effective regimens to patients suffering an early pregnancy loss “seems cruel.” She added that the most common complications of miscarriage include hemorrhaging and infection. While the risk of these complications is low, if they occur, failure to get proper treatment as soon as possible “can result in serious harm and injury.” Restricting access to mifepristone will be forcing American mothers to “accept substandard care for miscarriage management,” she said.
Kaye said it’s “devastating” to think about how much more people experiencing a miscarriage will suffer if the Supreme Court allows an unprecedented decision “based on junk science” to take effect. Kaye worries if this ruling takes effect, it will set a disconcerting precedent for science in general.
“If the Court sides with the anti-abortion extremists who brought this case, it will send a message that any idealogue who opposes a medication can use discredited experts and shoddy research to throw out the FDA’s evidence-based decisions,” she said. “That is very scary.”
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