What's next for the abortion pill mifepristone?
Updated April 10, 2023 at 3:29 PM ET
Access to a common abortion medication currently hangs in the balance in a pair of contradictory decisions by federal judges, setting the stage for the most significant legal action on abortion since the overturning of Roe v. Wade last year.
Mifepristone is widely used across the U.S. to end pregnancy in the first 10 weeks of gestation. About half of all abortions nationwide are performed using mifepristone as the first of a two-pill regimen. The drug is also commonly used to help manage miscarriages.
The name-brand drug Mifeprex was first approved by the Food and Drug Administration more than 20 years ago. Since then, it has been used millions of times, and major medical groups say it has a strong safety record. A generic version was approved in 2019.
Now, the drug's future is in jeopardy. A federal judge in Texas issued a preliminary injunction that undoes the FDA's approval of mifepristone nationwide beginning this Friday. Meanwhile, a competing ruling out of Washington state could limit the Texas injunction's reach.
The Biden administration has appealed the Texas decision and requested an emergency stay of the injunction. A federal appeals court is likely to weigh in this week.
Ultimately, it may be up to the Supreme Court to resolve the conflicts.
"Everyone's eyes are now pointed back towards D.C.," said Katie Glenn Daniel, the state policy director at Susan B. Anthony Pro-Life America. "We anticipate that eventually, whether it is the merits of this case or these injunctions — now dueling injunctions — that the Supreme Court will have to weigh in in some way."
Here's what you need to know:
Where do things stand now?
As of Monday, there is no change yet to Americans' ability to access mifepristone.
But that could change as soon as this Friday, when the preliminary injunction issued by U.S. District Judge Matthew Kacsmaryk is set to take effect.
The Texas lawsuit, filed by a coalition of abortion rights opponents, raised questions about the process by which the FDA originally approved the drug in 2000.
Kacsmaryk, a Trump appointee, agreed with their concerns and, in a preliminary ruling on Friday, declared the FDA's approval to be invalid. He stayed his own decision for seven days in order to give time for an appeals court to weigh in.
Meanwhile, there's a competing ruling out of Washington state, where the attorneys general of 17 states and the District of Columbia had sought to force the FDA to expand access to the drug.
The judge in that case, U.S. District Judge Thomas Rice, an Obama appointee, didn't go that far. But he did rule Friday that the agency cannot alter access to the drug while the lawsuit proceeds. That decision could offer relief if the Texas injunction goes into effect — though it would be limited to those 17 states and the District of Columbia.
(Those states are Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.)
For residents of those states, Rice's decision "preserves the status quo on ensuring that access to mifepristone remains available," said Washington Attorney General Bob Ferguson to NPR on Friday.
For the rest, Ferguson said, the Texas ruling "seriously has the potential to eliminate that access for mifepristone here in the coming days."
On Monday, the U.S. Department of Justice asked Judge Rice to clarify how the two rulings might interact.
The Texas ruling's quick timeline has left open a number of questions for medical providers and pharmacies regarding access to the widely used drug.
"For example, if medication is already in pharmacy and has already been prescribed, can those prescriptions be filled?" said David Donatti, an attorney at the ACLU of Texas. "These are questions that the lowest court order just does not answer."
What are the next steps in the legal process?
Ultimately, this is likely headed to the U.S. Supreme Court. But there are a few other steps first.
The DOJ has already appealed the Texas ruling. That will be heard by the Fifth Circuit Court of Appeals, which is generally a more conservative appeals court.
On Monday, the DOJ filed a request for an emergency stay of the injunction while the Fifth Circuit considers the appeal, asking the court to decide by noon CT on Thursday, April 13.
"Plaintiffs lack standing to challenge FDA's approval of a drug they neither take nor prescribe; their challenge to FDA actions dating back to 2000 is manifestly untimely; and they have provided no basis for second-guessing FDA's scientific judgment," the motion reads.
No matter which way the appeals court rules — on the emergency stay, the preliminary injunction or the merits of the lawsuit altogether — the decision will almost surely be appealed to the Supreme Court.
"We absolutely hope the Supreme Court resolves this issue once and for all. It's been decades in the making," said Chelsey Youman, an attorney with Human Coalition, an anti-abortion-rights group that filed an amicus brief in the Texas case.
How are abortion providers responding?
Like much of the past couple years since the Supreme Court swung conservative and Roe v. Wade was overturned, abortion providers have been consulting with lawyers and preparing for multiple scenarios.
"It's going to be working closely with legal advisers in a really rapidly changing environment. That's what I foresee in the next seven days, and likely beyond that," said Melissa Grant, the chief operating officer at Carafem, an abortion provider that provides mifepristone at its three physical clinics and via telehealth.
One possibility is for providers to switch to a one-pill protocol. In the U.S., mifepristone, which works by blocking the pregnancy hormone progesterone, is used in concert with a second pill, misoprostol, which causes the uterus to expel the pregnancy tissue. Used together, there are fewer side effects to a medication abortion.
But using only misoprostol can still be effective. Several major health organizations, including the World Health Organization and the American College of Obstetricians and Gynecologists, say the one-medication protocol is acceptable, especially when mifepristone isn't available.
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