Court’s decision keeps mifepristone safe for now
When Americans think of medication abortion, they typically refer to the medication regimen of mifepristone and misoprostol, which together have been shown to be highly effective and safe.
But women in some other nations traditionally have relied on misoprostol alone because it is more affordable and easier to access. When the U.S. Supreme Court decided to take up the case involving a Texas federal judge’s decision that would have overturned the Food and Drug Administration’s (FDA’s) approval of mifepristone more than 20 years ago, researchers decided to see what the evidence demonstrates about a medication abortion regimen that uses only misoprostol. Their findings were promising. As a recent paper notes, an updated misoprostol regimen is highly effective.1
“Last year, the FDA v. Hippocratic Medicine case was moving through the court,” says Heidi Moseson, PhD, MPH, senior research scientist and epidemiologist at Ibis Reproductive Health in Oakland, CA.
“Providers started to wonder what we could offer people if we lose access to mifepristone,” she adds. “We know there are two abortion medications endorsed by the World Health Organization (WHO).”
OB/GYNs and the reproductive healthcare community expressed relief in June, when the Supreme Court issued a decision that did not stop telehealth visits for medication abortion — a strong possibility given the same court had six justices who voted to overturn Roe v. Wade. But the decision said the plaintiffs lacked standing because there was no logical way they were harmed by the FDA’s decision to expand access to mifepristone through telehealth services.
“Even though the Supreme Court case was dismissed on standing, which it should be, mifepristone is much more heavily regulated than any other drug with a similar profile,” Moseson says. “Even under the status quo, providers have to jump through a lot of hoops to prescribe mifepristone to their patients.”
Some reproductive healthcare activists and groups have been asking the federal government and FDA to eliminate the additional restrictions on mifepristone, including the requirement that prescribers and pharmacies have to be certified before they can prescribe the medication. Mifepristone is listed under a single shared system risk evaluation and mitigation strategy (REMS), which has additional requirements for prescribing and distributing the drug.
The Supreme Court’s decision did not address the mountain of safety research showing that mifepristone was properly approved by the FDA, leaving open the possibility that another lawsuit with a different plaintiff could succeed in blocking or further restricting access to mifepristone.
Even if mifepristone is restricted further or removed, that will not end all medication abortion because misoprostol still is available and highly safe and effective with an updated protocol that is used across the world, Moseson says.
Misoprostol is a long-approved medication that was never designed to be used as an abortion pill, Moseson notes.
“Misoprostol is used for many indications, including gastric ulcers, induced abortion, miscarriage management, postpartum hemorrhage, and a wide range of other uses that are acceptable in most countries,” she says. “It wasn’t until the 1980s in Brazil when pregnant people in Brazil saw this warning label that said if you’re pregnant don’t take misoprostol, so they took it to induce a miscarriage, and it was discovered.”
Word of misoprostol’s abortifacient action spread through feminist networks, and researchers began to study it, Moseson says.
“When mifepristone was developed, it cannot induce abortion by itself, but when combined with misoprostol it is highly effective,” she adds. “In the U.S., we use the combined medications of one dose [of 200 mg] of mifepristone and four [doses of] 200 micrograms [800 micrograms total] of misoprostol because studies have consistently shown the combined regimen is 95% effective, and that’s become the gold standard.”
A misoprostol-only regimen should not be viewed as a replacement for the misoprostol/mifepristone regimen because people should have full access to all abortion medications, she says. “Right now, we offer one medication abortion option in the U.S. — mifepristone with misoprostol.”
There are disproportionate harms from abortion restrictions in the United States, Moseson says.
“Abortion restrictions impact people across the country and especially impact communities that already face barriers to care, including Black, Indigenous, people of color, and immigrants,” she adds. “They already face so many barriers, and this disproportionately impacts these folks.”
Telehealth medication abortion has eased some of the unfairness of these laws as people with less access and income can order their abortion pills through a telehealth visit and receive them to take in the comfort of their home, she says.
“Fortunately, we have awareness of how medication abortion and self-managed medication abortion remains highly safe and effective,” Moseson says. “People can have very safe abortions on their own.”
REFERENCE
- Moseson H, Jayaweera R, Baum SE, Gerdts C. How effective is misoprostol alone for medication abortion? NEJM Evid 2024;3:EVIDccon2300129.
