The Supreme Court will decide whether the Food and Drug Administration erred in its regulation of mifepristone, a commonly used abortion drug, in the first major abortion case since the landmark Dobbs v. Jackson Women’s Health Organization decision last year.
The court announced Wednesday it would hear oral arguments in two consolidated cases — FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine — but did not set a date for the arguments, possibly allowing the court to decide the case before July and ahead of the 2024 elections. But the court declined to take up the original 2000 approval of the drug, opting instead to focus only on questions of how and when it is dispensed.
White House Press Secretary Karine Jean-Pierre said the case “threatens to undermine the FDA’s scientific, independent judgment and would reimpose outdated restrictions on access to safe and effective medication abortion” and vowed that President Joe Biden would continue to fight for access to the drug.
“No woman should be unable to access the health care that she needs,” she said in a statement. “This should not happen in America, period.”
The national landscape concerning regulation of abortion rights has transformed since the June 2022 decision in the Dobbs case to overturn long-standing precedent under Roe v. Wade, which had protected the constitutional right to an abortion. Since then, states have passed or re-implemented laws limiting and in some cases banning nearly all abortions while also facing a new crop of litigation from abortion rights supporters.
The aftermath of the Dobbs decision has also seen an increased focus on regulations to mifepristone, a drug used for conducting medication abortions and for miscarriage management.
Opponents of mifepristone’s approval and use in the majority of abortions in the U.S. filed suit in November 2022, when a coalition of conservative doctors and physicians groups sued the FDA. The FDA initially approved the drug in 2000 and modified how the drug is regulated in 2016, 2021 and 2023, changing when it could be prescribed as well as who can prescribe or dispense the drug and also approving a generic form of the drug.
The Supreme Court paused changes to FDA’s regulation of mifepristone in April amid litigation, after Matthew Kacsmaryk, a judge for the U.S. District Court for the Northern District of Texas, ruled against the FDA’s approval of the drug earlier that month.
In August, a three-judge panel of the U.S. Court of Appeals for the 5th Circuit ruled against the FDA’s regulatory changes made after mifepristone’s 2000 approval but not against approval itself of the drug or its generic form.
The 5th Circuit’s majority opinion found that “in loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it.”
The agency did not consider the cumulative effect of removing different restrictions to the drug’s risk profile and did not present the court with evidence that the drug could be used safely when prescribed and dispensed remotely, that opinion states.
How the Supreme Court rules could also impact competing litigation seeking to protect access to the drug, including a case brought by Democratic attorneys general arguing current mifepristone regulations are too burdensome; a case brought by GenBioPro, the generic mifepristone manufacturer; and a case brought by the Center for Reproductive Rights in Virginia, Montana and Kansas seeking to preserve access to the drug.
Michael Macagnone contributed to this report.
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