On Wednesday, the fifth circuit court of appeals will consider the future of mifepristone, a crucial drug used in over half of US abortions, after a district court judge ruled the Food and Drug Administration (FDA) was wrong to approve it more than two decades ago. Access to the drug remains unchanged in states where abortion is still legal while the case proceeds.
The hearings follow a lengthy succession of court judgments. In late April, the supreme court blocked court-ordered restrictions on mifepristone while a lawsuit brought by anti-abortion groups targeting the pill continues.
The lawsuit is the most significant abortion rights case to make its way through the courts since Roe v Wade was overturned in 2022. Fourteen states have banned abortion in the last 11 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.
The Biden administration appealed the ruling to the supreme court, which temporarily blocked the lower courts’ decisions, returning the case to the fifth circuit. The high court also ruled that access to the pill will remain unchanged for the duration of the suit, which 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.
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 the Comstock Act have to do with it?
Court watchers are looking out for what the judges will say, if anything, about the Comstock Act – an 1873 anti-vice law banning certain products such as contraceptives, pornography and abortifacients from being sent through the mail. That law has effectively long been dead in the water, but the plaintiffs have tried to revive it, suggesting that the FDA ran afoul of the Comstock Act when it made pills obtainable by mail in 2021. Other anti-abortion activists have made similar efforts to bring back the law, viewing it as a possible avenue for banning abortion nationwide.
The Department of Justice issued an opinion on Comstock in December 2022, clarifying its own opinion that the law does not apply when the sender of pills intends for them to be used lawfully. When the appeals court first considered the mifepristone case in April, the panel of judges seemed to favor the plaintiffs’ arguments on Comstock, writing that the “plain text” of of the law prohibits the mailing of abortion drugs, regardless of whether they are intended for abortions.
If Comstock is ultimately affirmed as good law, it would have sweeping impacts on abortion in the US, as it could also be read to ban the mailing of any instrument used to perform abortions.
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.
Do the implications of the case go beyond abortion?
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.
