By Allison McCann and Amy Schoenfeld Walker
A closely watched lawsuit seeks to revoke the approval of the most common, safe and effective abortion pill regimen, with the potential for consequences to be felt in every state. A hearing in the case is scheduled Wednesday.
Nationally, more than half of reported abortions rely on medication, which is approved for use through the 10th week of pregnancy. Abortion pills are preferred among many patients and providers for their convenience, privacy and cost. Around 40% of the country’s clinics, including more than 80 telehealth providers, offer medication abortions only.
The federal case in Texas, filed late last year by a coalition of anti-abortion groups known as the Alliance for Hippocratic Medicine, claims that the Food and Drug Administration did not follow proper protocols in 2000 when it approved a two-drug abortion pill regimen of mifepristone followed by misoprostol and also that the medications are unsafe for patients.
A decision in favor of removing approval for the regimen would be unprecedented — apparently the first time that a court would order the FDA to revoke a drug against the agency’s will. The FDA would immediately appeal such a ruling. If allowed to stand, the decision could have significant ramifications in states where abortion is legal, not just in those trying to restrict it.
“This decision could definitely have an impact on what I can provide — in some ways this could be bigger than Dobbs,” Evelyn Kieltyka, the senior vice president for program services at Maine Family Planning, said, referring to the U.S. Supreme Court case that overturned Roe v. Wade last year.
Kieltyka’s organization relies on medication for about 60% of abortions and operates 17 medication-only clinics in mostly rural areas.
More than half of all abortions — and 64% of abortions before 10 weeks of pregnancy — relied on abortion pills in 2020, according to the Centers for Disease Control and Prevention. And in states like Colorado, Iowa, Maine, Nebraska, Vermont and Wyoming, the share of abortions done with medication was 70% or higher. (A few large states that also depend on medication abortion, including California and Illinois, did not report data or did not report data by method type to the CDC.)
About 5.6 million patients in the United States have used mifepristone followed by misoprostol for a medication abortion since the approval of the regimen in 2000.
Experts say the share of abortion patients choosing medication, rather than procedures such as aspiration, is higher because of the growth in telehealth abortion services. Patients increasingly turned to this option during the pandemic and after 13 states banned abortions following the overturn of Roe last year.
“There is no doubt in my mind that the share has increased since 2020,” said Ushma Upadhyay, a professor with Advancing New Standards in Reproductive Health at the University of California, San Francisco, who surveys abortion care providers.
It is unclear how the judge presiding over the case will rule, but he wrote an essay in 2015 that was critical of Roe. Abortion providers and advocates say they have prepared for possible outcomes, depending on the details of the ruling and whether the FDA successfully appeals an unfavorable decision.
But in several scenarios, some form of medication abortion could remain available.
The FDA has enforcement discretion over the drugs it approves, and a big question mark in the case is whether the federal government would enforce an unfavorable ruling, something the plaintiffs acknowledge.
“If the FDA were to withdraw these drugs, do manufacturers persist and continue to sell drugs illegally and hope there’s no prosecution from this administration?” said Erik Baptist, a lawyer with the plaintiffs’ legal team, the Alliance Defending Freedom.
Even if access to mifepristone were limited, abortion providers say they could rely solely on misoprostol, a regimen used internationally and endorsed by the World Health Organization. Research shows this option is safe, though it is somewhat less effective at terminating a pregnancy than the combination with mifepristone.
A ruling that limits the use of both drugs could further slow the pace of abortions in clinics that are already working to accommodate patients traveling from states with abortion bans, pushing abortions further out in pregnancy. Some providers say they could offer more procedural abortions, though these can be more costly, require additional clinician training and take more time to complete.
“If our clinic has to switch to doing procedures only, we simply will not be able to meet the demand,” said Ashley Brink, a clinic director at Trust Women Foundation. The foundation’s clinic in Wichita, Kansas, sees more than 500 patients a month, many from Texas, and 60% choose abortion pills.
“We could pivot and stretch ourselves, but you cannot make up 300 patients’ worth of appointments and procedures over the same amount of time,” she said.