#Abortion pill manufacturer asks Supreme Court to ensure access to mifepristone

The manufacturer of a common abortion drug on Friday asked the Supreme Court to overturn a ruling from a federal appeals court that would limit the availability of the pill.

The U.S. Court of Appeals for the 5th Circuit ruled in August that the brand name Mifeprex and its generic counterpart can stay on the market in states where abortion is legal, but that changes the Food and Drug Administration (FDA) has made since 2016 to ease access to the drug were not allowed because the agency did not follow proper procedure.

The conservative judges ruled the FDA acted improperly when it said mifepristone can be used up to 10 weeks of pregnancy rather than seven, allowed the medication to be mailed to patients, lowered the dosage and permitted providers other than physicians to prescribe the drug. 

That decision will remain on hold until the Supreme Court decides whether to take up the case in the term that begins in October. If that happens, arguments would likely happen sometime in early 2024, with a decision coming by the summer. 

The Justice Department had previously said it would separately appeal to the high court.

The case marks the highest stakes legal battle on abortion since the Supreme Court overturned Roe v. Wade last year. 

In a statement, manufacturer Danco Laboratories said it “continues to be at the forefront of this fight and is working closely with the reproductive rights community and pharmaceutical industry to support the changes made by FDA.”

In the filing, the company said its drug Mifeprex is safe and effective, and that the Fifth Circuit’s decision “upends FDA-approved conditions of use” for the drug.

The decision “raises questions about whether a single federal court can limit abortion access in the States that protect it. And it destabilizes the pharmaceutical and biotechnology industries by questioning when scientific studies — accepted by FDA — are sufficient to support conditions of use,” Danco attorney Jessica Ellsworth wrote.