AUSTIN, Texas — Access to the most commonly used method of abortion in the U.S. plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone which has been widely available for more than 20 years.

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

U.S. 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 came at the nearly same time that U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordered the opposite and directed U.S. 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 U.S. Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country.

“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.

The reversal of the FDA’s approval of mifepristone would apply to all states, even those where abortion rights are protected, like Maine. The decision could have major implications here.

Of the 21 clinics in Maine, 18 perform only medication abortions, according to a recent study. The other three offer both medication and procedural abortions.

Maine Family Planning, which runs most of the state’s clinics, estimates that 60 percent of its abortions use mifepristone. At Planned Parenthood of New England, approximately 70 percent of patients who choose to end their pregnancy in the first 11 weeks use mifepristone, the organization has said.

“This ruling is outrageous and should make clear to everyone that people opposed to abortion will not stop until abortion is banned everywhere, including here in Maine,” Nicole Clegg, Acting CEO, Planned Parenthood of Northern New England, said in an email Friday night. “Private medical decisions should be made by patients and their providers, not politicians and judges. “Medication abortion is a safe and legal; this politically motivated ruling has the potential to cause real harm.”

Both Maine Family Planning and Planned Parenthood have said they will continue to provide medication abortions and will switch to the misoprostol-only method if mifepristone becomes unavailable.

Maine Gov. Janet Mills criticized the decision.

“This reckless decision ignores basic science and facts and is yet another sad assault on the rights of women,” she said in a statement. “Mifepristone has been safely used since its approval more than two decades ago and is especially vital to ensuring that women in rural areas have access to abortion care. Abortion remains safe and legal in Maine, and I will continue to defend access to reproductive health care with all I have for Maine people.”

U.S. Rep. Chellie Pingree was similarly critical.

“It’s clear that extreme rightwing jurists will stop at nothing to ban abortion across the country, no matter what protections exist in our state,” she said in an email Friday. “We cannot and will not let them succeed.

“I will be closely following developments as this decision is appealed in the federal courts. Meanwhile, Congress must take action. The Protecting Access to Medication Abortion Act is a critical line of defense against the extreme attacks on women’s reproductive rights, and I am proud to be a cosponsor. Ultimately, we must also pass the Women’s Health Protection Act, which codifies the underlying right to an abortion.”

Mifepristone has been widely used in the U.S. 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 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.

“Simply put, FDA stonewalled judicial review – until now,” Kacsmaryk wrote.

He didn’t go as far as the plaintiffs wanted by withdrawing or suspending approval of the chemical abortion drug and removing it from the list of approved drugs.

Federal lawyers representing the FDA are expected to swiftly appeal. The White House was reviewing the decision.

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.

Mifepristone is part of a two-drug regimen that has long been the standard for medication abortion in the U.S. Clinics and doctors that prescribe the combination have said they plan to switch to using only misoprostol. The single-drug approach is slightly less effective at ending pregnancies.

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.

Democrats and abortion rights groups slammed the ruling out of Texas.

“Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away,” California Gov. Gavin Newsom said.

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 specializing 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, Greer and other experts said there would be little immediate impact.

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

 

Perrone and Whitehurst reported from Washington.

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