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Supreme Court Preserves Access to Mifepristone

— Decision avoids restrictions on widely used abortion pill while appeals process plays out

MedpageToday
A photo of a box of Mifeprex over a photo of the Supreme Court Building.

The Supreme Court on Friday to mifepristone (Mifeprex), a drug used in medication abortions by millions of women since its approval more than two decades ago, rejecting restrictions set to be imposed by lower courts while the case can be fully heard.

"Although the Supreme Court has kept mifepristone available to patients for the duration of this legal battle, much of the damage of this process remains in place," said Iffath Abbasi Hoskins, MD, and Maureen G. Phipps, MD, MPH, the president and CEO, respectively, of the American College of Obstetricians and Gynecologists (ACOG).

"We know that the attacks on abortion care will not stop, no matter how many times medical professionals declare that abortion is essential, evidence-based healthcare and that interference in the patient-physician relationship must stop," they continued. "We will continue to lead the medical community in providing the clear, strong evidence about mifepristone so that the Supreme Court can make the right decision in the end. ACOG remains steadfastly in opposition to interference in the patient-physician relationship."

In Friday's decision, the high court granted an "emergency stay" , allowing the appeals process to be heard. Justice Samuel Alito, who authored the Dobbs opinion overturning Roe v. Wade last June, and Justice Clarence Thomas, voted to let lower-court restrictions take effect.

Medication abortions account for more than half of all abortions nationwide. Part of a two-drug combination with misoprostol, mifepristone is the most commonly used medication for abortion. While misoprostol alone is safe and effective, it is not as effective as the two-drug regimen. The drugs are also commonly used in managing miscarriages.

Had the Supreme Court not extended the stay, the Fifth Circuit Court of Appeals' order would have gone into effect at 11:59 pm on Friday, banning the distribution of medication abortion through the mail, rolling back the gestational age at which an individual can be provided mifepristone from 10 weeks to 7 weeks, and reinstating rules around required physician visits.

Importantly, the Fifth Circuit Court's order would also have suspended the approval of generic mifepristone, which accounts for two-thirds of the available supply of the drug.

Over the last several weeks, the mifepristone saga has advanced through the courts rapidly. The most recent events began on Friday, April 7, when a federal judge in Texas -- Matthew Kacsmaryk -- issued a ruling ordering the suspension of FDA's 2000 approval of mifepristone, arguing that the approval process had been inappropriately rushed.

Then on April 12, before the Texas ruling was slated to take effect, a three-judge panel from the Fifth Circuit Court of Appeals in New Orleans acted to uphold parts of Kacsmaryk's order, but not all of it.

The Fifth Circuit's order said that the plaintiffs in the case -- the Alliance for Hippocratic Medicine (AHM), and other anti-abortion physicians -- had not given an adequate rationale for challenging mifepristone's original FDA approval. However, the judges said the AHM could challenge the FDA's 2016 risk evaluation and mitigation strategy (REMS) program and subsequent agency actions, including the 2019 approval of GenBioPro's generic mifepristone, and a 2021 REMS update that made the drug permanently available by mail.

On April 14, mifepristone maker Danco Laboratories and the Department of Justice, acting on behalf of the FDA, asked the Supreme Court to halt the Fifth Circuit's ruling. The high court then twice paused the lower court's decision, but only temporarily, leading to today's deadline.

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    Shannon Firth has been reporting on health policy as 鶹ý's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team.