Mifepristone is part of a two-drug protocol that a recent study showed was used in 98% of medication abortions in 2020.
Allen G. Breed/AP
Allen G. Breed/AP
A federal judge in Texas ruled Friday evening that the U.S. Food and Drug Administration improperly approved an abortion drug used in nearly all of the medication abortions in the U.S., putting access to the drug mifepristone in jeopardy.
U.S. District Judge Matthew Kacsmaryk gave the government a week to seek relief from an appeals court.
The judge’s decision won’t just affect people living in states where abortion has become illegal or heavily restricted: because the case is in federal court, the judge has the ability to issue a nationwide ruling affecting people in states where abortion is otherwise legal.
Mifepristone, was approved by the FDA in 2000 for use in combination with a second drug, misoprostol. More than half of all abortions in the United States are done using medication, as opposed to a surgical procedure, and the two-drug combination was used for 98% of them in 2020, according to the Guttmacher Institute.
A coalition of abortion rights opponents filed the lawsuit last year, saying the protocol was improperly approved by the Food and Drug Administration. The group had asked Kacsmaryk, who was appointed by President Trump and has longstanding ties to conservative religious groups, to overturn the approval.
The decision comes three weeks after Kacsmaryk held a hearing in Amarillo in a courtroom that had room for only a few dozen members of the public and the press. No recording or public livestreaming was permitted.
An appeal is expected to go to the U.S. Court of Appeals for the Fifth Circuit, which has a reputation for being a conservative jurisdiction. The case ultimately could end up before the U.S. Supreme Court.
Nationwide implications
Abortion providers nationwide say they’ve been preparing to rely on another medication abortion regimen using misoprostol alone. Misoprostol is prescribed primarily for ulcers, and is already widely used off-label for other gynecological purposes in the United States.
Research suggests the single-drug regimen is somewhat less effective and often causes additional side effects. But the World Health Organization says the method, which has been used internationally for decades, can be safe and effective at the appropriate dosage.
The decision likely will mean uncertainty and confusion for doctors and patients, says Farah Diaz-Tello, senior counsel with the reproductive rights legal advocacy group If/When/How.
“People who are seeking an abortion with pills … are going to find it much more difficult to do so, especially in the time period as providers figure out what they’re going to be able to do,” she says. “So I think we’re going to see an immediate exacerbation of the crisis of access that already started in June of 2022” with the U.S. Supreme Court decision last year in Dobbs v. Jackson Women’s Health Organization, which overturned decades of abortion-rights precedent.
Diaz-Tello predicts more people will look to induce their own abortions without medical supervision, using medications obtained online or in other countries. She also worries about the risk of increased scrutiny of patients seeking medical care for emergency complications from either self-managed abortions or miscarriages.
She says there are no state laws to her knowledge that require healthcare providers to turn in patients suspected of inducing an abortion, but she worries the ruling will fuel confusion and misinformation.
“I am worried that … that is going to translate into a misunderstanding that is going to lead to the criminalization of people who end their pregnancies,” Diaz-Tello says.