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Supreme Court Allows Abortion Pill Mifepristone to Stay on the Market
Justices block lower-court order that would have imposed new limits on drug
By Laura Kusisto and Jess Bravin, WSJ
Updated April 21, 2023 10:43 pm ET
WASHINGTON—The Supreme Court on Friday allowed the widely used abortion pill mifepristone to remain on the market indefinitely, granting emergency requests from the Biden administration and the brand-name manufacturer of the drug.
The high court blocked the effect of a lower-court order that was poised to limit access to the pill, which is used in more than half of U.S. abortions. The Supreme Court’s action wasn’t a decision on the merits of the case; instead, the justices were deciding whether the pill could remain available during a continuing legal challenge brought by antiabortion groups.
The court’s order was unsigned and provided no reasoning, as is typical in emergency actions. But it indicated that FDA-approved access to mifepristone would remain until litigation concludes in the lower courts and the Supreme Court itself has an opportunity to review those decisions—a timeline that likely will take many months.
The mifepristone pill’s brand-name manufacturer, along with the Biden administration, filed emergency appeals to keep current access in place. Photo: Callaghan O’Hare/Reuters
Two justices indicated they would have left the lower court order in place: Clarence Thomas and Samuel Alito.
In a brief dissent, Justice Alito said neither the FDA nor the drug’s maker had demonstrated they would suffer harm from limiting access to mifepristone. Besides, he said, there were “legitimate doubts” the government would obey lower-court orders restricting the drug, or that “it would choose to take enforcement actions to which it has strong objections.”
Medical associations and individual doctors who oppose abortion sued the Food and Drug Administration in November, contesting the agency’s initial approval of the pill in 2000, as well as more recent regulations that made the drug easier to obtain.
The case has moved rapidly from a courthouse in Amarillo, Texas, where a U.S. District Court judge appointed by former President Donald Trump suspended the pill’s approval, to the high court in a matter of weeks. In between, the New Orleans-based Fifth U.S. Circuit Court of Appeals narrowed the Texas judge’s injunction somewhat but ordered the FDA to reimpose a pre-2016 regimen for administering the drug. That included limiting its use to the earliest weeks of pregnancy, requiring three doctors’ visits, precluding mailing pills to patients and reintroducing a higher dosage than what is now used.
The Biden administration and Danco Laboratories LLC, which sells the pill under the brand name Mifeprex, filed emergency appeals last week asking the Supreme Court to intervene.
The Fifth Circuit is set to hear arguments in the case in mid-May and issue a more detailed ruling after that.
The case presented the Supreme Court with its first major test on abortion since its June ruling in Dobbs v. Jackson Women’s Health Organization ended federal constitutional protections for the procedure. Since then, more than a dozen states have banned many or most abortions.
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The mifepristone litigation has nationwide implications because a ruling against the FDA would reduce abortion access in states that have maintained protections for the procedure post-Dobbs. Providers in states where abortion remains legal have relied on the abortion pill to help meet increased demand. Some states have been amassing stockpiles of abortion drugs, in case court decisions limit future availability.
President Biden said the Supreme Court’s action would ensure access to the pill while the administration continues its battle in court. “The stakes could not be higher for women across America. I will continue to fight politically driven attacks on women’s health,” he said.
Danco attorney Jessica Ellsworth said, “The lower courts’ reversal of longstanding FDA approvals has caused widespread chaos among providers, patients, and healthcare systems. Today’s order provides continuity to all concerned as we litigate the underlying issues in this case.”
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The challengers have argued that the FDA improperly approved mifepristone under a pathway used to treat serious or life-threatening illnesses and failed to adequately consider potential safety concerns.
“The FDA must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is,” said Erik Baptist, an attorney with the Alliance Defending Freedom, which represents the plaintiffs. “We look forward to a final outcome in this case that will hold the FDA accountable.”
The FDA said it had extensive safety data that supported the drug’s approval in 2000 and later rules making the pill easier to obtain, noting that more than 5 million American women have used the pill over the past two decades. The Justice Department, representing the FDA in court, also argued the plaintiffs waited too long to sue and didn’t have standing to challenge the drug’s approval because their claims rested on speculation they might one day treat a woman experiencing complications from the drug.
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The department also has said the ruling could affect the drug’s use in miscarriage management.
Voters overwhelmingly opposed overturning FDA approval of mifepristone when asked in a Wall Street Journal poll this month. Some 66% said they didn’t want approval of the abortion pill to be reversed, while 25% favored a reversal of the FDA approval.
Democrats and independent voters in the survey opposed overturning the FDA approval by lopsided margins, while Republicans narrowly favored a reversal of the FDA decision, 46% to 39%.
Mifepristone is part of a two-step regimen. Up to two days after taking the drug, women usually take misoprostol, which causes uterine contractions. The lower-court orders don’t affect misoprostol, which isn’t FDA-approved for abortion on its own but could be prescribed off-label. Researchers say women seeking a medication abortion could take misoprostol alone, but it is less effective and can cause more significant side effects.
Aaron Zitner and Liz Essley Whyte contributed to this article.
Write to Laura Kusisto at Laura.Kusisto@wsj.com and Jess Bravin at Jess.Bravin@wsj.com
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