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Drug manufacturer asks Supreme Court to intervene in abortion drug dispute

Used boxes of Mifepristone pills, the first drug used in a medical abortion, fill a trash at Alamo Women's Clinic in Albuquerque, New Mexico, on Jan. 11, 2023. (Evleyn Hockstein/Reuters via CNN)

(CNN) — The manufacturer of a key medication abortion drug asked the Supreme Court on Friday to intervene in an emergency dispute over a Texas judge’s medication abortion drug ruling, requesting that the court step in now rather than wait for an appeal of the ruling to formally play out.

The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. It centers on the scope of the U.S. Food and Drug Administration’s authority to regulate a drug that is used in the majority of abortions today in states that still allow the procedure.

The Department of Justice is also expected to ask the justices to step in on an emergency basis before midnight Friday.

The clock is ticking. If the Supreme Court does not step in, the district court’s ruling, as amended by a subsequent appeals court opinion, will go into effect Friday night at midnight, and access to the drug mifepristone will be restricted while the appeals process plays out.

The controversy began when U.S. District Court Judge Matthew Kacsmaryk issued a broad ruling that blocks the FDA’s 2000 approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible.

Late Wednesday, the 5th U.S. Circuit Court of Appeals froze part of a ruling. The court said the drug, that was approved in 2000, could stay on the market, but agreed with Kacsmaryk that access could be limited.

The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital in person to obtain the drug.

The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10. It’s possible however that even with the ruling in effect, some providers could go “off label” and continue to prescribe mifepristone up until 10 weeks. Mifepristone is one of the drugs used for an abortion via medication as opposed to surgery.

CNN Supreme Court analyst Steve Vladeck, who is a professor at the University of Texas School of Law, said the ruling “froze the craziest, most harmful parts of Kacsmaryk’s ruling,” but that access to mifepristone is still significantly limited.

“The panel ruled that the challenge to the 2000 approval of mifepristone itself is likely time-barred, so it froze that part of the ruling,” he wrote on Twitter. “But it *didn’t* freeze Kacsmaryk’s block of the 2016 and 2021 revisions that (1) make mifepristone available up to 10 weeks; and (2) by mail.”

Medication abortion has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned the Roe v. Wade precedent that protected abortion rights nationally.

In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA’s 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.

A split 5th Circuit panel said in its order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. But the appeals court said that the abortion pill’s defenders had not shown that they were likely to succeed in defeating the plaintiffs’ claims against the FDA’s more recent regulatory actions toward mifepristone.

The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.

The FDA approved mifepristone after a four-year review process. It has shown to be a safe and effective way to terminate a pregnancy in the two-plus decades it’s been on the market. But anti-abortion doctors and medical associations allege that the agency ran afoul of the law by not adequately taking into account the drug’s supposed risks.