Access to abortion pill mifepristone in limbo after competing rulings in the US

A federal judge in Texas ordered a hold on the US approval of the abortion medication mifepristone. Photo / AP

Access to the most commonly used method of abortion in the United States has plunged into uncertainty after conflicting court rulings over the legality of the abortion medication mifepristone.

For now, the drug the Food and Drug Administration approved in 2000 appeared to remain at least immediately available, in the wake of two separate rulings that were issued in quick succession by federal judges in Texas and Washington on Friday.

US District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal approval of mifepristone in a decision that over-ruled decades of scientific approval.

But that decision came at nearly the same time that US District Judge Thomas O. Rice, an Obama appointee, essentially ordered the opposite and directed US authorities not to make any changes that would restrict access to the drug in at least 17 states, where Democrats sued in an effort to protect availability.

The extraordinary timing of the competing orders revealed the high stakes surrounding the drug, nearly a year after the US Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country. President Joe Biden said his administration would fight the Texas ruling.

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

“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.

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

The abortion drug has been widely used in the US since securing FDA approval and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration.

Mifepristone is one of two drugs used for medication abortion in the US, 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.

“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden said. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”

Clinics and doctors 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.

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 FDA’s decision-making lightly.” Kacsmaryk wrote. “But here, FDA acquiesced on 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 that 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 specialised review process reserved for drugs to treat “serious or life-threatening illnesses.”

The judge brushed aside FDA 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”.

His order also agreed with plaintiffs in invoking a controversial 19th century law that anti-abortion groups are now trying to revive to block sending abortion medications through the mail.

Originally passed in 1873 and named for an “anti-vice crusader,” the Comstock Act was used to prohibit the mailing of contraceptives, “lewd” writings and “instruments” that could be used in an abortion. The law was seldom invoked in the 50 years after Roe established a federal right to abortion.

Kacsmaryk, though, agreed with plaintiffs that the law — as literally interpreted — prohibits mailing mifepristone.

His order, if upheld, would also dismantle a number of recent FDA actions intended to ease access to the drug.

In late 2021, the FDA — under the Biden administration — dropped a requirement that women pick up the drug in person, opening the door to delivery by mail-order pharmacies.

In January the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.

Demonstrators on both sides of the abortion issue outside the US Supreme Court after it struck down Roe v Wade in June. Photo / The New York Times

Anti-abortion groups, which are newly encouraged about their ability to further restrict abortion and prevail in court, since last’s year’s reversal of Roe v. Wade, embraced the Texas ruling.

“The court’s decision is a major step forward for women and girls whose health and safety have been jeopardised for decades by the FDA’s rushed, flawed and politicised approval of these dangerous drugs,” said March for Life President Jeanne Mancini.

Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.

“This has never happened before in history — it’s a huge deal,” said Greer Donley, a professor specialising in reproductive health care at the University of Pittsburgh Law School.

“You have a federal judge who has zero scientific background second guessing every scientific decision that the FDA made.”

Still, because of the contradictory nature of the rulings, Donley and other experts said there would be little immediate impact.

“In the short term, nothing’s going to change,” Donley said. “This is the time to be preparing for the fact that in a week, potentially, mifepristone becomes an unapproved drug in this country.”