A panel of three federal court judges heard arguments Wednesday in a case that could force a major abortion pill off the market nationwide, including in states where abortion is legal.

The case hinges on whether the Food and Drug Administration’s approval of mifepristone, as well as subsequent actions making the drug easier to obtain, should be rolled back.

Abortion rights advocates have said the lawsuit has the potential to decimate nationwide access to medication abortion, which makes up over half of all abortions in the United States.

The panel of judges on the New Orleans-based 5th US Circuit Court of Appeals, considered among the most conservative in the country, is the latest federal court to weigh in on the case after a federal judge in Texas ordered a hold on FDA approval of mifepristone in April. The ruling was stayed pending appeal.

The Supreme Court last month decided mifepristone would remain available as the case made its way through the court system.

OTHER LAWSUITSWith eyes on Texas mifepristone case, 2 other abortion pill lawsuits ‘flying under the radar’

What happens now in mifepristone case?

The three-judge panel won’t issue a ruling on the case immediately. Once a decision is made, it is likely to be appealed to the U.S. Supreme Court.

Justice Department attorneys defend FDA approval

U.S. Department of Justice attorneys representing the FDA urged the panel to overturn last month’s ruling by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, that sought to suspend mifepristone’s FDA approval.

During an opening statement by Justice Department attorney Sarah Harrington, judges were quick to push back, including at Harrington’s description of the case as “unprecedented.” Judge James Ho said challenging the FDA’s expertise in court was not unprecedented, to which Harrington said, “But I don’t think there’s ever been any court that has vacated FDA’s determination that a drug is safe to be on the market.”

Harrington also argued that the doctors bringing the lawsuit have not shown they’ve been directly harmed by others prescribing mifepristone or forced to provide care that violates their beliefs. The judges also pushed back on this assertion and raised concerns about the safety of mifepristone, citing a study widely denounced by medical experts.

Justice Department attorneys and lawyers representing drugmaker Danco Laboratories argued in support of the safety and effectiveness of mifepristone and said the plaintiffs “used false math” in their case. The defendants also said withdrawing FDA approval will have ripple effects on dozens of other FDA-approved drugs.

On Friday, April 21, 2023, the Supreme Court halted restrictions that would have limited access to the abortion pill mifepristone, resolving a massive and fast moving conflict over access to the drug while the underlying lawsuit is decided.

Anti-abortion groups push to reverse FDA approval of mifepristone

Meanwhile, attorneys representing the Alliance for Hippocratic Medicine, a coalition of anti-abortion groups led by the Alliance Defending Freedom, claimed mifepristone is unsafe and its approval should be reversed.

“This case is not about ending abortion, it’s about ending a particularly dangerous type of abortion,” said Erin Hawley, senior counsel for Alliance for Defending Freedom.