Mifepristone is part of a two-drug regimen that a recent study found was used in 98% of medical abortions in 2020.
Allen G. Breed/AP
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Allen G. Breed/AP
Mifepristone is part of a two-drug regimen that a recent study found was used in 98% of medical abortions in 2020.
Allen G. Breed/AP
Federal judges made seemingly conflicting decisions Friday night that could drastically affect access to a drug used in nearly all drug abortions in the United States.
In Texas, US District Judge Matthew Kacsmaryk ruled that the US Food and Drug Administration improperly approved the drug mifepristone more than 20 years ago. He ordered the FDA to uphold its approval and give the government seven days to seek release from the appeals court.
Kacsmaryk’s decision will not only affect people living in states where abortion has become illegal or heavily restricted: because the case goes to federal court, the judge has the ability to nationwide rulings.
The White House is reviewing the ruling, according to a White House official not authorized to speak publicly.
Also on Friday, a federal judge’s ruling in a separate case filed in Washington state blocked the FDA from removing mifepristone from the market.
It is unclear how each judge’s decision will affect the other, and both cases will inevitably be appealed, potentially ending up before the US Supreme Court.
Mifepristone, was approved by the FDA in 2000 for use in combination with a second drug, misoprostol. More than half of all abortions in the United States are performed with medication, as opposed to a surgical procedure, and a two-drug combination was used for 98% of them in 2020, according to the Guttmacher Institute.
A coalition of abortion rights opponents filed a lawsuit in Texas last year, saying the protocol is Improper approval by the FDA. The group asked Kacsmaryk, who was appointed by President Trump and has longstanding ties to conservative religious groups, to overturn approval.
The decision came three weeks after Kacsmaryk held a hearing in Amarillo in a courtroom with only room for a few dozen members of the public and the press. Public recording or live streaming is not allowed.
The appeal is expected to be sent to the United States Court of Appeals for the Fifth Circuit, which is known for being a conservative jurisdiction. The case may eventually end up before the US Supreme Court.
National Meaning
Abortion providers nationwide say they have preparing rely on other medical abortion regimens using only misoprostol. Misoprostol is prescribed primarily for ulcers and has been used extensively outside of guidelines for other gynecological purposes in the United States.
Research shows that single-drug regimens are somewhat less effective and often cause additional side effects. But the World Health Organization says the method, which has been used internationally for decades, can be safe and effective in appropriate doses.
Farah Diaz-Tello, senior adviser to the reproductive rights legal advocacy group If/When/How, said the decision is likely to cause uncertainty and confusion for doctors and patient.
“People who are looking for a medical abortion… will have a harder time doing that, especially during a time when providers are figuring out what they can do,” she said. . “So I think we’re going to see an immediate exacerbation of the access crisis that began in June 2022” with the US Supreme Court’s ruling last year on Dobbs v. Jackson Women’s Health Foundationoverturned decades of abortion rights precedent.
Diaz-Tello predicts more people will seek abortions on their own without medical supervision, using drugs bought online or in other countries. She also worries about the increased risk of surveillance of patients seeking medical care due to emergency complications from self-abortion or miscarriage.
She said she is not aware of any state law that requires health care providers to turn over patients with suspected abortions, but she worries the ruling will cause confusion and wrong information.
“I’m worried that… that will lead to a misunderstanding that leads to the criminalization of people who have abortions,” Diaz-Tello said.
decided to duel
The implications of the Texas ruling are complicated by the outcome of the Washington state lawsuit filed by a coalition of 12 Democratic attorneys general. The group sought to prevent the FDA from withdrawing the drug from the market and asked the court to remove the agency’s additional layer of restriction on mifepristone.
The judge in that case ruled Friday that the defendants are barred from “changing the status quo and rights relating to the availability of Mifepristone.”
Washington State Attorney General Bob Ferguson has tell NPR that he believes his case could make it possible for patients in those dozens of states to continue using mifepristone for abortions — even if a federal judge in Texas issues a ruling that blocks access .
Amanda Allen, senior counsel and director of the Lawyers Project, which supports abortion rights, said the two courts “can make two very conflicting orders and they can impose very different obligations on with the FDA that the FDA won’t be able to do. to try to mediate.”
Allen said the FDA may decide to issue guidance to prescribers on how to interpret the rulings. But she said such a conflict between the federal courts would likely end up before the US Supreme Court.
