Judges' dueling decisions put access to a key abortion drug in jeopardy nationwide

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 hide caption

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Allen G. Breed/AP

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

Federal judges in two states issued contradictory decisions Friday night that could drastically impact access to a drug used in nearly all of the medication abortions in the U.S.

In Texas, U.S. District Judge Matthew Kacsmaryk ruled that the U.S. Food and Drug Administration improperly approved the drug mifepristone more than 20 years ago. He ordered to FDA to stay its approval and gave the government seven days to seek relief from an appeals court.

Kacsmaryk’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.

At the same time Friday, a federal judge’s ruling in a separate case in Washington state has blocked the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone.”

That lawsuit filed by a coalition of Democratic attorneys general in 17 states and the District of Columbia sought to block the FDA from pulling the drug from the market.

Washington state Attorney General Bob Ferguson told NPR on Friday that he believes the judge’s decision could make it possible for patients in those states to continue using mifepristone for abortion in the short term — even after the federal judge’s decision in Texas takes effect in seven days.

It’s not clear how each judge’s decision will impact the other, and both cases are likely to end up before the U.S. Supreme Court.

Hours after the Texas ruling, the Justice Department appealed to the U.S. Court of Appeals for the Fifth Circuit, which has a reputation for being a conservative jurisdiction. In a statement, U.S. Attorney General Merrick Garland said the judge’s decision “overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective.”

The Justice Department says it is also reviewing the decision in Washington state.

Anti-abortion groups hailed the decision in Texas. “By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions,” Erik Baptist of Alliance Defending Freedom said in a statement.

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 Texas lawsuit last year, saying the protocol was improperly approved by the FDA. 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 in that lawsuit 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.

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.

Dueling decisions

The implications of the Texas ruling is complicated by the outcome of the Washington state lawsuit.

Amanda Allen, senior counsel and director for the The Lawyering Project, which supports abortion rights, says the two courts “could come out with two very conflicting orders, and they could impose very different obligations on the FDA that would be very untenable for the FDA to try to reconcile.”

Allen says the FDA could decide to issue guidance for prescribers about how to interpret the rulings. But she says such a conflict between the federal courts might well end up before the U.S. Supreme Court.