Appeals court rules to keep abortion pill on the market but reinstates prior restrictions

A box containing a mifepristone tablet is pictured in a Feb. 28, 2023, photo. On April 21, the U.S. Supreme Court blocked a lower court's stay of FDA approval of a drug used in medication abortions. Mifepristone remains on the market while litigation over the drug proceeds. (OSV News photo/Callaghan O'Hare, Reuters)

WASHINGTON (OSV News) – A federal appeals court April 12 froze portions of a federal judge’s ruling suspending the U.S. Food and Drug Administration’s approval of a medication abortion pill, ruling that the drug can remain on the market but under more strict regulations while a challenge to it plays out.

The Justice Department said it would seek emergency relief from the Supreme Court over the appeals court’s ruling.

A three-judge panel of the 5th U.S. Circuit Court of Appeals agreed to temporarily block U.S. District Judge Matthew Kacsmaryk’s ruling, issued on Good Friday, which suspended the FDA’s approval of the drug mifepristone, the first of two drugs used in a medication or chemical abortion.

But in a 2-1 vote, the panel permitted other portions of that ruling to take effect, prohibiting mifepristone’s use after seven weeks of pregnancy and its distribution by mail, regulations that were in place prior to 2016 on a drug originally approved by the agency in 2000.

In an April 13 statement, Attorney General Merrick Garland said the Justice Department “strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal.”

“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Garland said.

A coalition of pro-life opponents of the drug mifepristone sought for the FDA’s approval of the drug to be revoked, arguing the government violated its own safety standard in approving the drug more than two decades ago.

Pro-life and pro-abortion activists recognized the mixed results of the appeals court ruling, with pro-life activists applauding reinstated restrictions and pro-abortion activists applauding that the drug will remain on shelves for the time being.

Jeanne Mancini, president of the March for Life, said in a statement that “we are pleased that the 5th Circuit Court of Appeals has temporarily reinstated important and commonsense health and safety protections surrounding the use of chemical abortion drugs.”

“The FDA’s elimination of these safeguards shows a reckless disregard for women’s health when it comes to abortion,” Mancini said. “This dangerous drug regimen has been shown to harm women, sometimes fatally, in addition to ending the lives of unborn children.”

NARAL Pro-Choice America President Mini Timmaraju said in a statement that “once again, we see that our court system has been rigged by the far-right to deliver results that are undemocratic and dangerous.”

“We’re relieved that the FDA’s approval of mifepristone stands for now, but by reinstating outdated and unnecessary restrictions, these judges – many of whom were appointed by a twice-impeached now-indicted former president – put tens of millions of people’s health at risk,” Timmaraju argued. “Anti-choice extremists want to ban all abortion, everywhere. They can’t win elections, so they’ve turned to the courts to do their dirty work. As this legal fight goes on, our reproductive freedom champions across the country must work to protect access to medication abortion no matter what happens next in the courts.”

But Katie Daniel, Susan B. Anthony Pro-Life America’s state policy director, said the group is “very encouraged by this landmark win for women and girls.”

“The Court recognized that the abortion pill is dangerous and rolled back Biden’s reckless mail-order abortion scheme,” Daniel said in a statement. “We still believe it never should have been approved in the first place and we look forward to the Supreme Court hearing this case.”

Daniel argued the FDA “has one job: safeguarding the lives and health of Americans.”

“The evidence clearly shows their failure when it comes to the abortion pill,” she said. “First, the FDA inappropriately fast-tracked this dangerous drug for approval without studying its effects in teenage girls. Then under the Obama and Biden administrations, they loosened one safety standard after another – finally approving mail-order abortion drugs and ignoring the critical importance of in-person doctor supervision – and stonewalled those who sought accountability. The rate of abortion pill-related emergency room visits has skyrocketed over 500% since it was approved, while the drug manufacturers have made a handsome profit – with investors reaping a 452% return on average.”

“The FDA ignored science and placed politics over the safety of women and girls, as well as the lives of countless unborn children,” Daniel argued. “Finally they are beginning to be held accountable.”

Scroll to Top