A federal judge in Texas on Friday suspended the Food and Drug Administration’s approval of mifepristone, one of the two drugs commonly used to end a pregnancy, throwing the future of the drug into question.
District court judge Matthew Kacsmaryk stayed his order, a preliminary injunction, for seven days to give the FDA time to appeal. Less than an hour after the Friday ruling, another federal judge in a separate case in Washington state directly contradicted Kacsmaryk’s ruling, ordering the FDA to refrain from making any changes to the availability of mifepristone.
The contradictory decisions increase the chances that the fate of the drug, first approved by the FDA more than two decades ago, will ultimately be decided by the supreme court, which overturned the federal right to abortion last year.
If Kacsmaryk’s ruling prevails, this will have huge implications for abortion and miscarriage care nationally, even in states where abortion is still legal. Considering more than half of abortions in the US are completed using pills, it could mean the biggest blow to reproductive rights since Roe v Wade was overturned.
It’s not entirely clear how the ruling will affect the immediate availability of mifepristone. Some experts believe the FDA does not have to enforce the judge’s ruling – a course of action that seems more likely following the Washington court’s order that the FDA maintain the status quo and refrain from any action to take the drug off the market. The FDA is likely to quickly appeal Kacsmaryk’s decision, but the legal status of the drug is likely to the subject of widespread confusion for some time.
In November, a lawsuit was filed by Alliance Defending Freedom (ADF), a conservative Christian legal advocacy group, arguing that the FDA exceeded its regulatory authority when it approved mifepristone – a drug that blocks progesterone, a hormone needed for a pregnancy to develop – more than two decades ago. The FDA vigorously rejected those arguments, pointing to repeated and rigorous reviews of the highly regulated drug.
In its complaint, the group also took issue with a 2016 FDA decision to extend the gestational age until which mifepristone could be prescribed – up to 10 weeks. It also argued against the FDA’s 2021 decision to remove the drug’s in-person dispensing requirement during the pandemic, which broadened access by allowing the drug to be prescribed via telehealth and sent in the mail.
Separately, the 113-page complaint originally submitted by ADF in November argued the FDA “failed to acknowledge” federal laws prohibiting medication abortion drugs from being sent in the postal mail, invoking a 19th-century law which made it illegal to mail “obscene, lewd or lascivious” items, including abortifacients. That law has been functionally dormant for decades but Kacsmaryk’s ruling appears to revive it, stating plainly that “FDA’s 2021 actions” – which lifted restrictions on mailing the drug – “violate the Comstock Act”.
The ADF is thought to have chosen to file the lawsuit in Amarillo, Texas, specifically so it would appear before Kacsmaryk, who is known for his anti-abortion views.
Although the ruling happened in Texas, it applies nationally.
Are abortion pills now banned?
Nothing will change for seven days, while the FDA appeals. Even beyond that, it is unclear how far the decision will stretch. Legal experts have said the FDA is not required to enforce Kasmaryck’s ruling, although the FDA has in the past leaned towards overcautiousness in its regulation of mifepristone. The dueling decision out of Washington makes the future of the drug even less certain.
In any event, in states where abortion is already banned, little will change: neither misoprostol or mifepristone has been legally available for abortions in these states since bans came into place after the fall of Roe.
Elsewhere, states that protect abortion may quickly move to clarify that misopristol, the second drug in the protocol, can still be safely and legally prescribed for abortions in their states.
While misoprostol – which helps to empty the uterus by causing the cervix to soften and dilate, and the uterus to contract – can be used safely on its own, it is less effective. Misoprostol-only abortions result in successful termination 88% of the time, and with more complicated side effects and more need for follow-up care, recent research has shown.
Some of the main abortion providers – including Planned Parenthood, Carafem and Abortion Delivered – have confirmed that that they are prepared to prescribe a misoprostol-only regimen for abortions in the event of mifepristone being pulled off the market. Aid Access, the international group that ships abortion pills to the US, trialled misoprostol-only regimens for abortions during the pandemic, with success.
Kacsmaryk has no jurisdiction overseas, so individuals may continue to acquire pills through online organizations that deliver them from outside the country. Doing so, however, is not without legal risk, and advocates advise consulting experts to minimize that risk.
What does this mean on the ground?
If mifepristone becomes unavailable, and since medication abortion accounts for more than half of US abortions, providers fear a surge of demand on clinics providing surgical procedures. Many are already under strain from an increase in patients traveling from states where abortion is banned or heavily restricted.
If doctors are unwilling to prescribe, or can’t access, either abortion drug, that could have a devastating impact on miscarriage management. “Hopefully doctors will find a way around it, but it ties doctors hands more, in terms of how they deal with pregnancy related emergencies,” says Mary Ziegler, an expert in US abortion law from the University of California, Davis.
Where does the case go next?
The FDA and Department of Health and Human Services can appeal Kascmaryk’s decision, taking it first to the fifth circuit, and then, if needed, to the supreme court.
But Elizabeth Nash of the Guttmacher Institute cautions that appealing through the fifth circuit may not garner a different result.
That court “is very conservative and has happily upheld abortion restrictions before. Given its demeanor and ideology, there’s no expectation the fifth circuit would do anything but confirm and approve the order”, she says.
What the supreme court may do is a bit more difficult to predict: “federal law is supposed to be supreme over state law, and the FDA regulates drugs and devices. They appropriately approved this drug and so, by that logic, this case really should have been laughed out of court. But it hasn’t been – and that means the supremacy clause in the US constitution becomes more and more important,” says Nash.
Jenny Ma, senior counsel for the Center for Reproductive Rights, warns that allowing judges and lawyers to bring cases like the Texas one does not set a good precedent.
“If plaintiffs can just bring lawsuits like this, based on junk science, the impact goes far beyond medication abortion. It really seeks to undermine the entirety of FDA authority over drug approval,” said Ma.
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