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 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.
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.
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.
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?
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 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. 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.
Where does the case currently 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.
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.
The dueling decisions make it more likely that the supreme court will ultimately decide the issue.
Are abortion pills now banned?
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.
Legal scholars have also suggested that the FDA also does not actually have to enforce a judicial decision against the drug.
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.
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.
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 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.
What will the supreme court do?
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.
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.
