Abortion pill mifepristone in legal limbo in the US after competing rulings

Access to the most commonly used method of abortion in the United States plunged into uncertainty on Friday following conflicting court rulings over the legality of the abortion medication mifepristone that has been widely available for more than 20 years.

For now, the drug that the Food and Drug Administration (FDA) approved in 2000 remains at least immediately available in the wake of the separate rulings that were issued just minutes apart by federal judges in Texas and Washington state.

US District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision was quickly followed by US District Judge Thomas O. Rice, an Obama appointee, essentially ordering the opposite and directing US authorities not to make any changes that would restrict access to the drug.

The extraordinary timing of the competing orders revealed the high stakes that surround the drug a year after the US Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country.

Accelerated path to Supreme Court likely

The Justice Department swiftly gave notice it would appeal the Texas ruling and said it was reviewing the decision from Washington state.

The whiplash of the conflicting decisions is likely to put the issue on an accelerated path to the Supreme Court.

“The FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.

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A conservative Texas judge is now considering arguments in a case that could ban the commonly used abortion bill of mifepristone in the United States. Last November, a coalition of anti-abortion groups filed a lawsuit to reverse federal approval of the pill.

Abortion providers slammed the Texas ruling, including Whole Woman’s Health, which operates six clinics in five states and said it would continue to dispense mifepristone in person and by mail over the next week as it reviews the rulings.

The abortion drug has been widely used in the US since 2000, and there is essentially no precedent for a lone judge overruling the medical decisions of the FDA. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.

Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.

“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” US Attorney General Merrick Garland said. “The department will continue to defend the FDA’s decision.”

Other drugs available

Doctors and clinics that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.

The lawsuit in the Texas case was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.

Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.

Boxes of pills are seen stacked on a shelf.
Boxes of the drug mifepristone line a shelf at the West Alabama Women’s Center in Tuscaloosa, Ala., in March 2022. (Allen G. Breed/The Associated Press)

Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s filing. Kacsmaryk essentially agreed with the plaintiffs on all of their major points, including that the FDA didn’t adequately review mifepristone’s safety.

“The court does not second-guess the FDA’s decision-making lightly,” wrote Kacsmaryk. “But here, the FDA acknowledged its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone occur at a lower rate than those seen with wisdom teeth removal, colonoscopies and other routine medical procedures, medical groups have recently noted.

Elsewhere, Kacsmaryk sided with plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part, by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.” The judge brushed aside the FDA’s arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a “natural process essential to perpetuating human life.”

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