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Judges' dueling decisions put access to a key abortion drug in jeopardy nationwide

A federal judge in Texas stayed the FDA's approval of the drug mifepristone, while a federal judge in Washington state blocked any FDA change in access.



Mifepristone is part of a two-drug protocol that a recent study showed was used in 98% of medication abortions in 2020.
Mifepristone is part of a two-drug protocol that a recent study showed was used in 98% of medication abortions in 2020. Allen G. Breed | AP
Updated April 8, 2023 at 5:45 AM ET

Federal judges in two states issued contradictory decisions Friday evening that could drastically impact access to a drug used in nearly all medication abortions in the U.S.

In Texas, U.S. District Judge Matthew Kacsmaryk ruled that the Food and Drug Administration improperly approved the abortion pill mifepristone more than 20 years ago. A coalition of anti-abortion rights groups called the Alliance for Hippocratic Medicine sued the FDA last year. The judge issued a nationwide injunction pausing the FDA's approval, which is set to take effect in seven days.

Within hours of that decision, U.S. District Judge Thomas O. Rice issued a ruling in a separate case in Washington state. That lawsuit filed by a coalition of Democratic attorneys general in 17 states and the District of Columbia sought to block the FDA from pulling the drug from the market.

Rice's decision blocks the FDA from "altering the status quo and rights as it relates to the availability of Mifepristone."

Washington state Attorney General Bob Ferguson told NPR on Friday that he believes the judge's ruling could make it possible for patients in those states to continue using mifepristone for abortion in the short term — even after the Texas decision takes effect.

"If you live in Washington State or one of the 17 states that joined Washington in our lawsuit...then the judge's ruling in our case preserves the status quo on ensuring that access to mifepristone remains available," Ferguson said. For the rest, he said, "The Texas judge's ruling seriously has the potential to eliminate that access for mifepristone here in the coming days."

Most abortions already are illegal in about a dozen of those states, including Texas, following last summer's Dobbs v. Jackson Women's Health Organization decision.

Hours after the Texas ruling, the Justice Department appealed to the U.S. Court of Appeals for the Fifth Circuit, which has a reputation for being a conservative jurisdiction. The Justice Department says it is also reviewing the decision in Washington state.

President Biden said the ruling in Texas could have widespread consequences. "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," the president said in a statement.

"It is the next big step toward the national ban on abortion that Republican elected officials have vowed to make law in America," Biden added.

He said that the administration would fight the ruling, noting, "The Department of Justice has already filed an appeal and will seek an immediate stay of the decision."

Anti-abortion rights groups hailed the Texas decision. "By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm's way, and it's high time the agency is held accountable for its reckless actions," Erik Baptist, senior counsel with Alliance Defending Freedom, said in a statement.

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 done using medication, as opposed to a surgical procedure, and the two-drug combination was used for 98% of them in 2020, according to the Guttmacher Institute.

Major medical groups say mifepristone, which is also used in miscarriage management, has a well-established safety record and have been calling for relaxing restrictions on its use for years.

In its lawsuit, the coalition of abortion rights opponents said the protocol was improperly approved by the FDA. The group had asked Kacsmaryk, who was appointed by President Trump and has longstanding ties to conservative religious groups, to overturn the approval.

The decision in that lawsuit comes three weeks after Kacsmaryk held a hearing in Amarillo in a courtroom that had room for only a few dozen members of the public and the press. No recording or public livestreaming was permitted.

Nationwide implications

Abortion providers nationwide say they've been preparing to rely on another medication abortion regimen using misoprostol alone. Misoprostol is prescribed primarily for ulcers, and is already widely used off-label for other gynecological purposes in the United States.

Research suggests the single-drug regimen is somewhat less effective and often causes additional side effects. But the World Health Organization says the method, which has been used internationally for decades, can be safe and effective at the appropriate dosage.

The decision likely will mean uncertainty and confusion for doctors and patients, says Farah Diaz-Tello, senior counsel with the reproductive rights legal advocacy group If/When/How.

"People who are seeking an abortion with pills ... are going to find it much more difficult to do so, especially in the time period as providers figure out what they're going to be able to do," she says. "So I think we're going to see an immediate exacerbation of the crisis of access that already started in June of 2022" with the U.S. Supreme Court decision last year in Dobbs v. Jackson Women's Health Organization, which overturned decades of abortion-rights precedent.

Diaz-Tello predicts more people will look to induce their own abortions without medical supervision, using medications obtained online or in other countries. She also worries about the risk of increased scrutiny of patients seeking medical care for emergency complications from either self-managed abortions or miscarriages.

She says there are no state laws to her knowledge that require healthcare providers to turn in patients suspected of inducing an abortion, but she worries the ruling will fuel confusion and misinformation.

"I am worried that ... that is going to translate into a misunderstanding that is going to lead to the criminalization of people who end their pregnancies," Diaz-Tello says.

Dueling decisions

The implications of the Texas ruling is complicated by the outcome of the Washington state lawsuit.

Prior to the rulings being issued, Amanda Allen, senior counsel and director for the The Lawyering Project, which supports abortion rights, told NPR that the prospect of "two very conflicting orders" from federal courts "could impose very different obligations on the FDA that would be very untenable for the FDA to try to reconcile."

Allen said the FDA could decide to issue guidance for prescribers about how to interpret the rulings. But she says such a conflict between the federal courts might well end up before the U.S. Supreme Court.

Lawyers and advocates on both sides of the case say it is likely to move quickly through the federal appeals process.

"Everyone's eyes are now kind of pointed back towards D.C.," said Katie Glenn Daniel, state policy director with Susan B. Anthony Pro-Life America. "We anticipate that eventually, whether it's the merits of this case, or these injunctions — now dueling injunctions — that the Supreme Court will have to weigh in in some way."

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Transcript :


Access to a key abortion medication is in jeopardy after a federal judge in Texas sided with anti-abortion advocates in an unprecedented lawsuit. For the next seven days, the ruling pauses the Food and Drug Administration's approval of mifepristone, a medication that it first cleared for use in the United States in 2000. At the same time, another lawsuit has just blocked the FDA from removing the drug from the market. So what does this all mean?

To help us sort it out, we've called on national correspondent Sarah McCammon. Hi, Sarah.


FLORIDO: All right. So you have been reporting on these cases for weeks. What is the significance of this medication?

MCCAMMON: Well, it's incredibly significant because mifepristone, which has been on the market for more than 20 years, and it's part of a two-drug protocol used to terminate first trimester pregnancies - it's used in nearly all medication abortions in the United States, and most - more than half of abortions in the United States are medication abortions. So this is used by a lot of people. And because of the significance of this pill, Adrian, you know, particularly at a time when abortion is increasingly restricted and illegal in more than a dozen states, this medication has been a major focus of legislation and litigation.

FLORIDO: Well, these two cases that I mentioned seem to go in opposite directions. What are they about, and what just happened?

MCCAMMON: Well, they both center on the FDA approval and regulation of mifepristone. So in the Texas case, which came first, late last year, anti-abortion groups challenged the FDA approval - again, from more than 20 years ago - asked a federal judge to take it off the market, essentially. That judge - the judge in this case is Matthew Kaczmarek. He was appointed by former President Donald Trump. He has a long conservative track record and was widely expected to do what he did today, which is to issue a nationwide injunction aimed at pulling mifepristone from the market.

Now, the Washington case - the second case - is a direct response to that. It was filed several weeks ago by a group of Democratic state attorneys general. They asked another federal judge to essentially do the opposite - relax the rules and prevent the FDA from taking the drug off the market. They were also more or less successful. You know, people are still reading both of these decisions, so it's hard to know exactly what they mean. But we do know that Judge Kaczmarek's decision doesn't take effect for seven days.

FLORIDO: And so what happens in the meantime - over the next seven days?

MCCAMMON: Well, the Washington decision - you know, abortion rights advocates hope it will help to preserve access to abortion pills. Abortion rights opponents tell me, you know, they're reading this decision and reading it differently, as you might expect. So I think everyone is still kind of taking it in. But leading up to today, Adrian, there was a lot of uncertainty I was hearing from lawyers as well as medical providers about how this would all play out, particularly if there were dueling decisions. You know, what happens next? I don't think we fully know. It's not exactly clear how each of these rulings will affect the other. They're both likely to be appealed, and it's also very likely this will end up at the Supreme Court.

FLORIDO: What else are you hearing today from abortion rights groups and others?

MCCAMMON: Well, abortion rights groups are expressing outrage and concern and, again, hopeful that this ruling in Washington will help protect access to these pills. There's a lot of celebration from anti-abortion rights groups. The Students for Life of America group sent out a statement saying it's a good Friday, indeed, referring to the Christian holiday that's being observed today ahead of Easter weekend. But Adrian, what all sides seem to agree is, again, that this case is very likely to end up before the U.S. Supreme Court, and I think that's something that anti-abortion groups would welcome.

FLORIDO: I've been speaking with NPR's Sarah McCammon. Thanks very much.

MCCAMMON: Thank you. Transcript provided by NPR, Copyright NPR.