Supreme Court to rule on FDA approval of abortion drug mifepristone

The U.S. Supreme Court will hear oral arguments Tuesday about the federal government's approval process for the drug mifepristone, used to terminate pregnancies.

Bottles of the abortion pills mifepristone, left, and misoprostol, right, at a clinic. (Charlie Neibergall)

While the case hinges on complex federal regulatory procedures, reproductive rights will again be the key question – an appeal with enormous legal, social, and political implications, and a high-stakes following to the Court's landmark ruling striking down Roe v. Wade.

New data from the Guttmacher Institute research group indicates nearly two-thirds of all abortions in the U.S. in 2023 rely on mifepristone. Abortion rights groups say the drug has been proven safe and that the Court's decision could negatively impact 40 million women nationwide. Anti-abortion organizations counter that the U.S. Food and Drug Administration for two decades has unlawfully promoted a nationwide regime of on-demand abortion, in defiance of several state health and safety laws. 

For now, the Supreme Court is allowing the FDA to continue regulating the drug while the appeals process plays out. That includes continued telemedicine prescriptions and retail pharmacy dispensing.

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"I think it probably was a little premature to say that the court was going to be getting out of the abortion business entirely," Thomas Dupree, a former top official in the justice department of former President George W. Bush. "I think the justices are aware of the fact, obviously, that we're in an election year, but I don't think the fact that we're in an election year is going to be driving the outcomes of any of these decisions."

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., March 16, 2022.  (Allen G. Breed, File)

Thirty-six states allow some form of access to mifepristone – 21 states allow full access and 15 allow restricted access, according to Fox News research. Fourteen states ban abortion completely – including medication abortion – except for a few exceptions.

Danco Laboratories, the drug's manufacturer, had appealed to the Supreme Court seeking final review on the merits.

Dozens of advocacy groups, members of Congress, and coalitions of states on both sides of the issue have filed legal "amicus" briefs in recent weeks.

The plaintiffs are led by four national medical associations of anti-abortion doctors linked to the conservative advocacy group Alliance Defending Freedom. They sued the FDA shortly after the Dobbs ruling, which ADF also spearheaded, hoping to build momentum on further abortion restrictions through litigation.

"The FDA recklessly removed its original safeguards like in-person doctor visits leaving women to suffer serious complications alone," said ADF Senior Counsel Erin Hawley, who will argue the case before the Court. "It’s appalling that the FDA would eliminate even the initial in-person visit to check for life-threatening conditions like ectopic pregnancy based on studies it said were not adequate. Women deserve better."

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Lower courts agreed with anti-abortion groups, concluding the FDA did not fully consider the potential health risks to women when amending guidelines for mifepristone eight years ago.

The Supreme Court  (Mariam Zuhaib)

And this will not be the only abortion issue the Supreme Court is confronting.

The justices next month will hold oral arguments on a challenge to Idaho's restrictions and whether they violate federal laws requiring hospitals to treat patients in life-threatening crises.

A federal court blocked enforcement of Idaho’s Defense of Life Act, which prohibits abortions unless necessary to save the life of the mother, on the ground that the federal Emergency Medical Treatment and Labor Act preempts it. The state's near-total abortion ban establishes criminal penalties for doctors who perform the procedure, except under narrow circumstances.

But the Biden administration counters that federal law requires emergency rooms to provide "stabilizing care," including abortions, for a broader range of circumstances than a mother's life, such as when a patient's health is in "serious jeopardy." 

Other pending court challenges that may eventually reach the justices include whether the federal Title X family planning program can refer patients for abortions; and whether those whose religious faith supports abortion access can file First Amendment constitutional challenges to state bans.

Pro-life women celebrate following the Supreme Court's decision to overturn Roe v. Wade outside the Supreme Court in Washington June 24, 2022. (Gemunu Amarasinghe)

However, if the Court rules on these disputes, the political impact could be immediate and seismic in the November election. Many progressives, while denouncing the 2022 Dobbs decision striking down the federal right to abortion, credited the controversy for energizing the base, as well as swing voters. The midterm elections produced better than expected results for Democrats, while exposing a strategic vulnerability for Republicans and denying them an expected "red wave."

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What the Supreme Court decides in June when confronted with the abortion pill case could have a similar impact – with nine appointed women and men in robes poised to reignite a divisive referendum on arguably the most controversial social issue facing the nation.     

The mifepristone cases are FDA v. Alliance for Hippocratic Medicine (23-235) and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine (23-236).

Shannon Bream currently serves as anchor of FOX News Sunday. She joined the network in 2007 as a Washington D.C- based correspondent covering the Supreme Court. Her latest book is "The Love Stories of the Bible Speak."

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