American women could be one Texas ruling away from losing access to mifepristone

American women looking to end a pregnancy might soon be unable to take mifepristone, a drug used for medication abortion through the 10th week of pregnancy. A federal court in Texas is expected to rule on a lawsuit it heard earlier this month seeking to revoke the FDA’s authorization of the medication, which was issued in 2000.

The lawsuit was brought by the Alliance Defending Freedom, a group involved in Dobbs v. Jackson Women’s Health, the Mississippi case that eventually led to the overturning of Roe v Wade. The group argues that mifepristone was approved through an accelerated process usually reserved for lifesaving drugs, and that since pregnancy is not a disease, the approval process was inappropriate, and unsafe. In reality, the FDA’s review, while technically on an accelerated track, still took years, and there has been no evidence of serious safety issues in the two decades since.

Medication abortion is obtained with a combination of two drugs: mifepristone, which breaks down the lining of the uterus, stopping the pregnancy, and misoprostol, which stimulates contractions and the expulsion of the fetal material.

The FDA considers mifepristone a safe drug with relatively minor side effects, typically cramping and light bleeding. More adverse effects are extremely rare (pdf), with a mortality rate of 0.65 per every 100,000 medication abortions.

Revoking the authorization of a drug without evidence of serious risks, more than 20 years after it was allowed on the market, would be an unprecedented move. Yet the judge hearing the case in the Amarillo division of the US District of Northern Texas, Donald Trump nominee Matthew Kacsmaryk, has long held anti-abortion beliefs, and his previous decisions suggest he might rule against the FDA.

Removing access to the most common abortion method

If Kacsmaryk decides to revoke FDA approval, mifepristone—currently available in some pharmacies, as well as abortion clinics—could no longer be prescribed.

In all likelihood the decision would be appealed. The case would then go to the US Court of Appeals for the Fifth Circuit, which oversees Texas cases and is notoriously conservative. After that, the last resort would be the US Supreme Court.

If the decision were confirmed, the FDA would have to pull mifepristone from the market. The agency could eventually try to restart the approval process, but it might take years before the drug is available again. This would eliminate the most common—and least invasive—way to have abortions, leaving women with the choice of having a surgical one, or one only with misoprostol.

Other options would skirt legality, or expose women to a variety of risks. For example, some might risk breaking the law and resort to ordering the drug online from international distributors, exposing themselves to potentially dangerous products. Some clinics, meanwhile, are reportedly stocking up on mifepristone, but they might not be allowed to administer it.