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Abortion pill ruling: will the US supreme court hear another abortion case? Abortion pill case: what does the supreme court order mean and what comes next?
(8 days later)
An appeals court has reimposed restrictions on mifepristone in a closely watched case that could have a major impact on access to medication abortion The supreme court on Friday blocked restrictions ordered by lower courts on mifepristone
Late on Wednesday, an appellate court ruled partially in favor of anti-abortion advocates in a case challenging the Food and Drug Administration’s authorization of mifepristone, a key abortion drug. The supreme court on Friday blocked restrictions on mifepristone while a lawsuit brought by anti-abortion groups targeting the pill proceeds.
The decision by the fifth circuit court of appeals imposes restrictions on mifepristone that include lowering the use of the drug to seven weeks of pregnancy instead of the current 10-week limit, and requiring in-person doctor visits for those looking to obtain the drug. In an unsigned order, the justices granted an emergency request by the Biden administration to prevent a lower court ruling targeting the Food and Drug Administration’s regulation of the pill. As a result of the supreme court’s order, access to the drug will remain unchanged as the case proceeds.
That case continues to make its way through the courts, with the Biden administration on Thursday confirming it intends to immediately appeal the fifth circuit’s decision to the supreme court. Reproductive rights groups anxiously awaited the high court’s decision, as a refusal to block the lower court rulings would have meant significantly curtailed access to the most common method of abortion in the US, with consequences for miscarriage care as well.
The appeals court decision came after a federal judge in Texas on Friday suspended the FDA’s approval of mifepristone, one of the two drugs commonly used to end a pregnancy, throwing the future of the drug’s availability in the US into question. It is the most significant abortion rights case to make its way through the courts since Roe v Wade was overturned in 2022. Although 13 states have banned abortion in the last nine months, new restrictions on the pill would apply even in states where the procedure is still allowed.
If the appellate court 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.
What happened?What happened?
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 November a lawsuit was filed by the Christian legal group Alliance Defending Freedom (ADF), arguing that the FDA exceeded its regulatory authority and ignored safety concerns 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. A Trump-appointed federal judge in Texas, Matthew Kacsmaryk, sided with the plaintiffs, issuing a preliminary injunction on 7 April suspending the FDA’s 23-year-old approval of mifepristone. He also endorsed the plaintiffs’ views that a previously dormant, 150-year-old anti-vice law called the Comstock Act “plainly forecloses mail-order abortion”.
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 appeals court from Wednesday night also references the law in its decision. Abortion rights advocates fear that efforts to revive the law will extend to medical equipment and any other object required to administer an abortion. 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, and employed anti-abortion rhetoric throughout his decision, referring to mifepristone as a drug used to “kill the unborn human”.
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. The appeals court is also considered very conservative; two of the three judges who signed Wednesday’s decision were appointed by Donald Trump, as was Kacsmaryk. The Biden administration took the decision to the fifth circuit court of appeals, where two judges – also appointed by Donald Trump – blocked the part of the ruling overturning the FDA’s initial 2000 approval of mifepristone, but reimposed restrictions on the drug previously lifted by the FDA. They include limiting mifepristone use after seven weeks of pregnancy – it is currently approved through 10 weeks – and banning delivery by mail. The FDA had decided in 2021 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.
Where does the case currently stand? Where does the case stand?
The fifth circuit decision reinstates restrictions on mifepristone that had been in place before being lifted in 2016. The Department of Justice has announced that it will quickly appeal to the supreme court for an emergency stay of the fifth circuit decision. The supreme court has fully stayed Kacsmaryk’s order. The case returns to the fifth circuit, which has scheduled oral arguments for 17 May, and will very likely return to the supreme court.
Last Friday, shortly after the district court ruling in Texas, 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. What is the status of the abortion pill?
The dueling decisions make it more likely that the supreme court will ultimately decide the issue. For the moment, mifepristone has not been banned and access remains unaffected as the case proceeds. Misoprostol, the second drug commonly administered alongside mifepristone to induce a medical abortion, is not at issue in this lawsuit.
Are abortion pills now banned? Legal scholars have suggested that the FDA also does not actually have to enforce a judicial decision against the drug.
For the moment, mifepristone has not been banned – the 2016 restrictions will go into effect this weekend if the supreme court does not intervene. Misoprostol, the second drug commonly administered alongside mifepristone to induce a medical abortion, is not affected by the ruling. There are also some questions about how the FDA and doctors prescribing mifepristone will choose to follow the ruling should it be upheld by the supreme court. Doctors frequently prescribe drugs “off-label” – meaning they could prescribe it after seven weeks if they choose. Even a supreme court ruling should have little impact in states where abortion is already banned: neither misoprostol nor mifepristone has been legally available for abortions in these states since bans came into place after the fall of Roe.
Legal scholars have also suggested that the FDA also does not actually have to enforce a judicial decision against the drug. If mifepristone becomes more difficult to access, 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.
But even a supreme court ruling should have little impact in states where abortion is already banned: neither misoprostol nor mifepristone has been legally available for abortions in these states since bans came into place after the fall of Roe. 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.
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 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.Some of the main abortion providers – including Planned Parenthood, Carafem and Abortion Delivered – have confirmed 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.
What does this mean on the ground?What does this mean on the ground?
If mifepristone becomes less available, 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 mifepristone becomes less available, 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. Online pharmacies and other telehealth providers have proliferated since Roe v Wade was overturned, enabled by the FDA’s 2021 decision to allow abortion pills to be sent in the mail. If the courts ultimately rule that mifepristone cannot be mailed, this could shutter those businesses.
What will the supreme court do? Why did the supreme court block the order?
Many abortion advocates have feared this moment, considering the conservative court’s decision to overturn Roe v Wade last summer, but what the court will choose to do in this case is 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. Many abortion advocates have feared this moment, considering the conservative court’s decision to overturn Roe v Wade last summer, but supreme court precedent has generally been deferential to the FDA when it comes to regulating drugs.
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. The Biden administration, along with a coalition of pharmaceutical companies, warned of ensuing regulatory chaos around drug approvals should the judiciary be permitted to order regulations on mifepristone opposed by the FDA.
“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. “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,” Biden said in a written statement after Kacsmaryk’s decision in early April. Although reproductive rights groups celebrated the supreme courts action to temporarily block the lower court ruling, they also noted that it has no bearing on how the case will ultimately be decided.
“This is very welcome news, but it’s frightening to think that Americans came within hours of losing access to a medication that is used in most abortions in this country and has been used for decades by millions of people to safely end a pregnancy or treat a miscarriage,” said Jennifer Dalven, director of the Reproductive Freedom Project at the American Civil Liberties Union. “Make no mistake, we aren’t out of the woods by any means. This case, which should have been laughed out of court from the very start, will continue on.”