The Fifth US Circuit Court of Appeals ruled Wednesday that the abortion pill mifepristone should remain legal but with significant limits on patients’ ability to access it. The medication, part of a two-drug combination used to end early pregnancies, cannot be sent through the mail or prescribed via telemedicine, according to the decision, nor can it be prescribed by professionals who are not physicians. Under the ruling, patients would have to make three doctors’ visits to obtain the medication. Here are questions and answers about the decision’s implications.
When does the ruling take effect?
The ruling has no immediate effect. The Supreme Court ruled in April that mifepristone must remain available under current rules until all appeals are exhausted. The Justice Department has already announced it would appeal Wednesday’s ruling, so the question rests with the Supreme Court.
What is likely to happen with the Supreme Court?
That is always hard to predict, said I. Glenn Cohen, a Harvard law professor who specializes in health law and bioethics.
The court could decline to review the case and leave the appeals court ruling in place. Cohen considers that unlikely.
Cohen, who favors maintaining access to mifepristone, is holding out hope that the court will throw the case out on the grounds that the plaintiffs don’t have the standing to challenge the FDA. That would be an easy way to get rid of a case the court may not welcome, he said. In overturning Roe vs. Wade, the court had said the question of abortion rights should be decided by elected officials in each state. But restricting mifepristone would impose nationwide limits.
If the court does review the case, it could swing either way, Cohen said. It’s likely that Justices Clarence Thomas and Samuel A. Alito Jr. would want to uphold restrictions on the abortion pill, while Sonia Sotomayor, Elena Kagan, and Ketanji Brown Jackson will want to overturn them. But where the other justices would fall is impossible to predict.
If the appeals court ruling is upheld, what will be the result?
Women will have a harder time obtaining the most popular method of abortion, a two-drug combination used in more than half of all abortions. The pill will be available, but restrictions that were in place until 2015 would be restored.
But it won’t be exactly like turning back the clock to 2015, Cohen notes. In 2015, abortion was still constitutionally protected. Now, with many states banning or severely restricting the procedure, prohibitions on mailing the drug or prescribing it remotely will remove the last option for many.
What will be the effect in Massachusetts?
The ruling will apply equally to all states. However, those that favor abortion rights, such as Massachusetts, have explored ways to work around it. For example, Governor Maura Healey obtained 15,000 doses of mifepristone in April, close to two years’ worth. She also issued an executive order stating that medical abortion and mifepristone are covered by a state law passed last year intended to shield providers from out-of-state prosecution.
Does the ruling potentially have implications for the FDA’s regulatory authority?
“The level of scrutiny they’re putting to the FDA decision here is pretty dramatic and pretty unparalleled,” Cohen said. If a similar detailed analysis were applied to every action by the agency, “many drugs would run into similar problems,” he said.
Courts will not be motivated to pursue such second-guessing of FDA decisions in most cases, except for “drugs that touch on a cultural issue,” such as birth control and hormones to treat transgender people, Cohen said.
How did this case come to be?
Several anti-abortion doctors and a consortium of anti-abortion medical groups called the Alliance for Hippocratic Medicine filed the suit in November, challenging the FDA’s 23-year-old decision to approve the drug.
In April, District Court Judge Matthew Kacsmaryk of Texas, who was appointed by President Trump and has publicly espoused anti-abortion views, effectively nullified the FDA’s approval of the pill.
But the appeals court decision found that the statute of limitations prevented a challenge to a decision made in 2000, and kept the FDA’s approval in place. But it also found that the FDA’s 2016 and 2021 decisions lifting restrictions on the drug could be challenged.
On Wednesday, it voted 2 to 1 to invalidate the 2016 and 2021 actions. The court found that the FDA failed to consider the cumulative effects of lifting the various restrictions, Cohen said. While it looked at the effects of each individual change, it did not consider them together. The ruling also criticized the agency for saying that there were no data showing a risk, when the agency had failed to gather such data.
Is mifepristone dangerous?
In the 23 years that mifepristone has been on the market, research has shown that serious complications are rare. Less than 1 percent of patients need hospitalization. The drug has been regulated more strictly and studied more intensively than most drugs. It is also approved for use in dozens of other countries.
Material from wire services was used in this report.