AUSTIN, Texas (AP) — 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 that 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 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 abortion drug 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.”
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BELLINGHAM, Wash. (AP) — Washington state has purchased a three-year supply of a leading abortion medication in anticipation of a court ruling that could limit its availability, Gov. Jay Inslee said Tuesday.
The Democratic governor said he ordered the Department of Corrections, which has a pharmacy license, to buy 30,000 doses of the generic version of mifepristone at a cost of about $1.28 million, or $42.50 per pill. The shipment arrived in late March.
A two-pill combination of mifepristone and misoprostol is the most common form of abortion in the U.S. Research shows that medication-induced abortions are safe and effective. They were approved by the Food and Drug Administration over 20 years ago.
The awaited ruling in a Texas lawsuit brought by a Christian group — in the wake of the U.S. Supreme Court decision last year to strip away the constitutional right to end a pregnancy — would affect states where abortion is legal as well as those that outlaw it.
“This Texas lawsuit is a clear and present danger to patients and providers all across the country," Inslee said in a statement. “Washington will not sit by idly and risk the devastating consequences of inaction.”
Former President Donald Trump-appointed Judge Matthew Kacsmaryk heard debate in March over the Alliance Defending Freedom’s request to revoke or suspend the FDA’s approval of mifepristone. The conservative group claims it was improperly approved.
Kacsmaryk said he would rule “as soon as possible” without giving any clear indication of how he might decide.
The bulk pill purchase also comes as Washington state Attorney General Bob Ferguson pursues the issue from another angle: He's helping to lead a multistate lawsuit in federal court meant to further ease restrictions to the medication.
The lawsuit filed with Oregon Attorney General Ellen Rosenblum in February against the FDA accuses it of singling out mifepristone for excessively burdensome regulation despite evidence that the drug is safer than Tylenol, Ferguson said in a statement at the time.
The lawsuit asks the court to find certain FDA restrictions unlawful and to stop the federal agency from enforcing or applying them to mifepristone.
State lawmakers are also bringing legislation that will authorize the state Department of Corrections to sell or distribute the drug stockpile to licensed providers in Washington.
The bill's co-sponsor, Sen. Karen Keiser, of Des Moines, said the last year has made it clear that they can't be complacent when it comes to reproductive health.
“The Legislature is taking a number of crucial steps this session to protect abortion rights," Keiser said, “but those rights are meaningless without access to care.”
Several moves have been made in Washington to strengthen abortion access, including a directive from Inslee instructing the Washington State Patrol not to cooperate with out-of-state abortion investigations. Other abortion and gender-affirming care bills are expected to pass the Washington Legislature this session.
Abortion has been legal in Washington since a 1970 statewide ballot referendum.