The supreme court on Friday blocked restrictions ordered by lower courts on mifepristone
The supreme court on Friday blocked restrictions on mifepristone while a lawsuit brought by anti-abortion groups targeting the pill proceeds.
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 for now.
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.
US supreme court blocks ruling limiting access to abortion pill
It is the most significant abortion rights case to make its way through the courts since Roe v Wade was overturned in 2022. Thirteen states have banned abortion in the last nine months, but new restrictions on the pill would apply even in states where the procedure is still allowed.
What happened?
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.
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”.
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 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 stand?
The supreme court has fully stayed Kacsmaryk’s order. The case now returns to the fifth circuit, which has scheduled oral arguments for 17 May, and will very likely make its way back to the supreme court.
What is the status of the abortion pill?
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.
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.
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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.
What could this case mean for abortion access?
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.
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.
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. While Friday order did not include any reasoning for the decision, supreme court precedent has generally been deferential to the FDA when it comes to regulating drugs.
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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 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.”
