U.S. appeals court preserves partial access to abortion pill, but with tighter rules
A federal appeals court will allow partial access to the abortion drug mifepristone while a high-profile federal case plays out, but with new limitations on how the drug can be dispensed.
The U.S. Court of Appeals for the 5th Circuit says the drug, used in most medication abortions in the United States, remains approved for use up to seven weeks of pregnancy while the case is being appealed.
Previously, the drug was approved for up to 10 weeks. The ruling also says mifepristone can no longer be sent in the mail at least for now.
The Biden administration says it will appeal the Fifth Circuit's decision to the U.S. Supreme Court.
Late last week, U.S. District Judge Matthew Kacsmaryk sided with anti-abortion rights groups that sued the Food and Drug Administration over its approval of the abortion pill mifepristone. He issued a ruling that would invalidate the drug's approval beginning this Friday unless the appeals court intervenes.
On Monday, the Department of Justice asked the Fifth Circuit for an emergency stay of Kacsmaryk's decision while the court hears the case. In their request, Justice Department lawyers argued that "the district court upended decades of reliance by blocking FDA's approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court's own misguided assessment of the drug's safety."
Mifepristone was approved by the FDA in 2000 and is now used in combination with another drug, misoprostol, in nearly all medication abortions in the United States. Mifepristone was initially approved for medication abortion through seven weeks of pregnancy, but in 2016, the FDA expanded that to 10 weeks.
The appeals court's decision means mifepristone will continue to be at least partially available while the case plays out.
It's unclear how the latest decision will interact with a ruling in a separate federal case in Washington state, filed by attorneys general from 17 states and the District of Columbia who are seeking to preserve access to the pills.
In that decision, also issued Friday shortly after Kacsmaryk released his ruling, U.S. District Judge Thomas O. Rice said the FDA was prohibited from "altering the status quo and rights as it relates to the availability of Mifepristone."
Washington state Attorney General Bob Ferguson, one of the leaders of that effort, told NPR he believes it will preserve access to mifepristone for people in those 17 states and D.C., unless a higher court says otherwise.
The Justice Department also filed a motion Monday asking Rice to clarify the meaning of his ruling, given there appears to be "tension" with Kacsmaryk's nationwide injunction.
On Thursday evening, Rice issued an order affirming that for the 17 states and D.C. — the parties in the case before him — access to mifepristone should remain unchanged, regardless of the Texas judge's injunction and the Fifth Circuit's decision. So these cases remain on a collision course.
A Supreme Court decision could clarify the path forward.
Meanwhile, several states led by Democratic governors have begun stockpiling abortion pills — either mifepristone or another drug, misoprostol. Misoprostol is usually used in combination with mifepristone but can be used alone to induce abortion.
Massachusetts Gov. Maura Healey and Washington Gov. Jay Inslee have announced that their states have begun stockpiling mifepristone in the event that access is disrupted. California Gov. Gavin Newsom and New York Gov. Kathy Hochul say their states are stockpiling tens of thousands of doses of misoprostol.
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Transcript
LEILA FADEL, HOST:
Two of 3 judges on a federal appeals court are now the ones deciding how patients can get an abortion drug.
STEVE INSKEEP, HOST:
The judges answered an appeal to keep it available. As we have reported, a single federal judge decided the other day that the Food and Drug Administration improperly approved mifepristone two decades ago. Now a three-judge panel has made its own judgment. All three judges blocked the ruling, which means that mifepristone remains available. But 2 of 3 voted to uphold some restrictions on how it is distributed.
FADEL: NPR's Sarah McCammon has been covering this and joins us now to explain what this all means. Hi, Sarah.
SARAH MCCAMMON, BYLINE: Good morning.
FADEL: Good morning. So what does the decision say?
MCCAMMON: Well, just as a reminder, you know, this all started because a conservative-leaning federal judge in Texas named Matthew Kaczmarek had ordered the abortion drug mifepristone essentially to be taken off the market, starting tomorrow. Now, the Biden administration appealed that right away. And in the meantime, the Department of Justice asked the Fifth Circuit Appeals Court for an emergency stay. That would put Kaczmarek's whole decision on hold while this case plays out. And that would allow patients to keep getting this drug, you know, which is a key part of the standard protocol for abortions - for medication abortions in the U.S. And it's used, by many estimates, in more than half of abortions now.
So anti-abortion groups, of course, are challenging the Food and Drug Administration approval of mifepristone and some of the rule changes that FDA has made since then. Leila, what the Fifth Circuit did overnight is to grant part of the Biden administration request for a stay. So the FDA approval stays in place, but the court essentially has rolled back some of the rule changes in recent years that had expanded access to the drug.
FADEL: OK. So what does that practically mean for people who want to access this medication? What's changing? What's not?
MCCAMMON: Right. Well, this court - which also has a reputation for being a very conservative court, by the way - said that the statute of limitations has passed to challenge the original FDA approval of the drug back in 2000. But they said that more recent rule changes could be considered. So at least right now, the court is doing away with a couple of key changes.
FADEL: OK.
MCCAMMON: One is that the drug was originally approved for use up to seven weeks of pregnancy. Then the FDA expanded that to 10 weeks in 2016. This ruling just sets that back to seven weeks. And that's potentially a big deal because many people don't know they're pregnant that early on. Those three weeks can make a big difference. And, you know, already, Leila, some doctors prescribe a little past 10 weeks. So it's unclear what this might mean for, you know, off-label prescriptions. But that's what the court is saying.
The court's also saying that these pills can no longer be sent in the mail. And that's significant because, you know, mifepristone is subject to a lot of additional restrictions above and beyond typical prescription drugs. And one thing the Biden administration had done in 2021 was to make permanent a rule change that had kind of started during the pandemic, allowing these drugs to be sent through the mail for people who consult with doctors over telehealth. This decision does away with that, too. And, you know, I should mention that all of this is being appealed. Ultimately, where this all lands is unclear. But that's where things stand right now.
FADEL: And just really briefly, if you could talk about the on-the-ground impact, then, of this decision.
MCCAMMON: You know, it's early, but I anticipate a lot of continued concern from abortion-rights groups. I mean, this does preserve some access. As I said, it rolls back some existing access. And also, you know, one thing I noticed is the court, in its decision, mentions the idea of Comstock laws, which are 19th century laws that restrict the mailing of materials, including things used in abortion. The Biden administration has said that the Comstock act does not apply here to the mailing of abortion pills, but the court in its ruling seemed favorable to the idea that it might apply and might restrict mailing pills.
FADEL: NPR's Sarah McCammon. Thanks so much, Sarah.
MCCAMMON: Thank you. Transcript provided by NPR, Copyright NPR.
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