The Supreme Court said Wednesday it will take up a case that could limit the availability of the common abortion pill mifepristone, bringing the issue of abortion back to the court more than a year after the justices ended the constitutional right to one.
The court granted a request from the Justice Department and one from Danco, the manufacturer of Mifeprex, the branded version of mifepristone.
The brief orders consolidate the two cases and set them up to be heard this term, with a decision expected by the end of June.
In the meantime, access to mifepristone remains unchanged under a previous emergency ruling by the Supreme Court.
Mifepristone is widely used across the U.S. to end a pregnancy in the first 10 weeks of gestation. It was first approved in 2000, and about half of all abortions nationwide are performed using mifepristone as the first of a two-pill regimen. It is also used to help manage miscarriages.
The lawsuit is not focused on abortion access, but rather the Food and Drug Administration’s (FDA) drug approval process. The decision could have major implications for the biopharma industry.
The U.S. Court of Appeals for the 5th Circuit ruled in August that mifepristone — both Mifeprex and its generic counterpart — can stay on the market in states where abortion is legal, but changes the FDA made since 2016 to ease access to the drug were not allowed because the agency did not follow proper procedure in enacting them.
The Biden administration and the manufacturer both appealed that latter portion to the Supreme Court, urging the justices to preserve the recent changes as lawful.
The group of anti-abortion providers that brought the suit, represented by Alliance Defending Freedom (ADF), a conservative Christian legal powerhouse, urged the high court to stay out the case.
But the ADF told the justices that if they did hear the appeals from the Justice Department and Danco, they should review the entirety of the earlier ruling — including whether mifepristone should remain on the market at all.
“FDA’s early actions in approving mifepristone are inextricably intertwined with its more recent decisions to remove critical safeguards surrounding its use,” the group wrote. “To review one without the other is like reading a novel starting in the middle.”
The Supreme Court’s orders reject that request, agreeing only to weigh in on the recent changes that eased access.
The Biden administration warned that upending mifepristone’s original approval would disrupt the “long-established status quo” and call into question the FDA’s broader authority.
“FDA approved mifepristone as safe and effective in 2000,” the Justice Department wrote in court filings.
“The agency has maintained that scientific judgment across five presidential administrations, while updating the drug’s approved conditions of use based on additional evidence and experience,” the administration told the justices. “More than five million Americans have relied on mifepristone to terminate their pregnancies, and public health authorities around the world have likewise approved the drug.”
