On Tuesday, March 26 the Supreme Court of the United States heard a case involving the broad availability of mifepristone, the safest and most widely used medication for abortion care. A group of Texas doctors brought the lawsuit originally challenging the Food and Drug Administration’s initial approval of the medication more than two decades ago. The Fifth Circuit Court of Appeals rejected the challenge to the FDA’s original approval, but ruled to reverse a series of recent FDA measures that made the medication more widely available. A ruling from the Supreme Court is expected before the end of summer. 

Mifepristone remains available while the case is pending. While Illinois has worked to ensure that abortion remains legal after the Dobbs’ ruling, access to mifepristone could be impacted here based on the Court’s decision.

What is mifepristone?

Mifepristone is one of two drugs commonly used in abortion and miscarriage care. It was first approved by the FDA in 2000 and has been used safely by more than five million people in the United States for more than two decades.

Mifepristone is currently used for over half of all abortions in the U.S. Studies show that mifepristone is exceedingly safe and effective – in fact, when it comes to serious medical complications, mifepristone is safer than Tylenol or Viagra. Mifepristone has been especially critical in expanding reproductive care access in low-income, underserved, and rural communities where the burden and cost of obtaining a procedural abortion are much higher.

What is the lawsuit about?

A group of anti-abortion doctors filed a lawsuit challenging the FDA’s initial decision to approve mifepristone.  The court of appeals held that these plaintiff did not have standing to challenge this approval because too much time has passed since mifepristone’s approval 23 years ago.  The Supreme Court has not taken up this part of the case.

The plaintiffs also challenged more recent FDA decisions that permitted mifepristone to be dispensed by mail and allowed pharmacies to fill mifepristone prescriptions, among other things. These anti-abortion doctors argue that FDA allegedly  didn’t adequately consider the drug’s safety record and that its actions  purportedly violate a 150-year-old law called the Comstock Act that banned sending “immoral” things through the mail.

A key issue in this case will be the plaintiffs’ ability to bring this case.  To file a lawsuit, a plaintiff must have what’s called “standing”––meaning  they have been injured and a court’s decision in their favor will redress that harm. Here, the plaintiffs do not prescribe mifepristone. Instead, they speculate that someday they might have to provide care for a patient suffering adverse consequences from taking mifepristone. That’s usually too hypothetical to support a lawsuit.

There are also serious problems with the merits of the plaintiffs’ claims. The FDA has compiled a voluminous, decades-long body of data demonstrating mifepristone’s safety. And since the early 20th century, courts have agreed that the Comstock Act does not prohibit mailing items designed to produce abortions where the sender does not intend them to be used unlawfully.

What is the lawsuit’s status?

It’s important to be clear that currently, the lawsuit has not changed mifepristone’s availability.  Although the trial court judge, a Trump appointee in Texas, and the Fifth Circuit Court of Appeals issued rulings that would have restricted mifepristone’s availability, these orders are not currently in effect while the case plays out before the United States Supreme Court.

Illinois has also joined a separate lawsuit to preserve mifepristone access, and the court in that case has ordered the FDA not to take any steps to alter mifepristone’s availability in Illinois. That case is still pending.