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Supreme Court could soon rule on abortion drug

An appeals court decision restricting availability of mifepristone goes into effect after midnight Wednesday unless the high court acts

A counter protester demonstrates as others rally in support of abortion rights at the U.S. Supreme Court in Washington last Saturday.
A counter protester demonstrates as others rally in support of abortion rights at the U.S. Supreme Court in Washington last Saturday. (Andrew Caballero-Reynolds/AFP via Getty Images)

The Supreme Court could soon decide the availability of a commonly used abortion drug after an alliance of conservative medical groups filed a brief Tuesday asking it to let a court ruling restricting access to the drug go into effect.

Alliance Defending Freedom, a legal advocacy group representing the medical groups, submitted its brief Tuesday ahead of a noon court deadline, opening the door for the Supreme Court to weigh in on the abortion drug less than a year after the Dobbs v. Jackson Women’s Health Organization decision overturned the national right to an abortion.

Unless the Supreme Court rules by midnight Wednesday, an appeals court ruling restricting availability of the drug would go into effect.

The case centers on the Food and Drug Administration’s 2000 approval of mifepristone, which is used in a two-drug regimen with misoprostol for medication abortions and in miscarriage management. Since the drug’s original 2000 approval, the agency has expanded how far into pregnancy the drug can be used and how and where it can be dispensed to patients seeking abortions.

On Friday, the Supreme Court temporarily paused a court order from Judge Matthew Kacsmaryk in the U.S. District Court for the Northern District of Texas that would have suspended the original 2000 approval of mifepristone.

Kacsmaryk’s decision went to the 5th Circuit Court of Appeals, which weighed in with a ruling that restricted but did not outright suspend the approval of the drug. After that, the Justice Department and drugmaker Danco Laboratories asked the high court to intervene.

Alliance Defending Freedom, in its brief, argued that lifting the lower court decisions would be harmful to its clients and to women taking the drug.

“The only effect of the lower court’s order is to restore a modicum of safety for the women and girls who use the drug, including supervision and oversight by a physician. If this litigation involved any other drug, there would not even be a debate as to whether this Court should intervene mid-litigation stream with extraordinary relief,” the brief stated.

The group also argued that the status quo would harm the anti-abortion physicians by “forcing them to perform elective abortions violating their conscience rights and interfering with their medical practice.”

The physician group asked the Supreme Court to consider key pieces of the cases in the lower courts, including the dispute over whether mailing abortion drugs violates federal criminal law and whether the FDA improperly approved the drug in 2000.

The 5th Circuit’s order, which paused the FDA’s 2016 and 2021 revisions to how mifepristone is dispensed, would have “the effect of restoring crucial safeguards FDA once deemed necessary to protect women from the inherent risks of chemical abortion,” the Alliance Defending Freedom brief argued.

The DOJ argued in its brief that Kacsmaryk’s decision upended the health care industry’s reliance on FDA approvals and conflicted with a Washington district court decision to keep the status quo on mifepristone for 17 states and the District of Columbia, according to the Biden administration.

“If allowed to take effect, the lower courts’ orders would thwart FDA’s scientific judgment and undermine widespread reliance in a healthcare system that assumes the availability of mifepristone as an alternative to more burdensome and invasive surgical abortions,” the DOJ brief said.

A group of 147 Republican lawmakers submitted a brief Tuesday in support of the lower court rulings, calling efforts to deregulate mifepristone “a dangerous game with the health and safety of women and girls.”

“By exceeding the scope of its authorized power from Congress, the FDA has subverted Congress’ public policy interests in patient safety,” the brief said, going on to argue that “fundamentally, chemical abortion drugs pose serious health and safety risks to women and girls. The FDA’s deregulation of the drugs only exacerbates those risks.”

The brief also argued the FDA’s approval of mifepristone violated a 2003 law that required the agency to consider the effect medication abortion could have on minors as compared with adults.

On Friday, a group of 253 Democratic lawmakers also weighed in, asking the Supreme Court to pause Kacsmaryk’s original ruling and leave mifepristone on the market while the case plays out. The brief, which included 203 out of 213 Democratic House members and all members of the Senate Democratic Conference except for Joe Manchin III of West Virginia, argued the decision would restrict access to abortion nationwide.

“More immediately, the misguided stay of mifepristone’s current FDA-approved conditions of use will reduce access to abortion, exacerbating an already significant reproductive health crisis,” the brief said.

On the Republican side, at least two lawmakers — Rep. Nancy Mace, R-S.C., and Sen. Lisa Murkowski, R-Alaska — have criticized the lawsuit.

Rep. Andy Harris, R-Md., who chairs the House Agriculture Appropriations Subcommittee, said he is likely to offer an amendment to the coming fiscal 2024 House spending bill later this year to restrict mifepristone. The committee holds jurisdiction over the FDA budget.

“Look, I agree with the 5th Circuit. If you read the appeals court opinion, I think they called it right. That was done improperly,” said Harris.

Harris offered an amendment last year that would block the FDA from dispensing mifepristone without an in-person appointment from a provider. The amendment was rejected 26-32.

“I suspect that that is going to be one of the amendments requested,” he said Monday. “The Supreme Court may be ruling as early as [Tuesday] or Wednesday. We may know more likely whether or not the courts are going to deal with that or if we have to.”

Ellyn Ferguson contributed to this report.

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