The Biden administration formally asked the Supreme Court on Friday to review and overturn a ruling from a federal appeals court that would limit the availability of the common abortion pill mifepristone.
DOJ’s request followed a separate one made Friday by Danco Laboratories, the manufacturer of the brand name Mifeprex. In its filing, the company said its drug is safe and effective, and that the appeals court decision “upends FDA-approved conditions of use” for the drug.
Mifepristone is widely used across the U.S. to end a pregnancy in the first 10 weeks of gestation, and was first approved in 2000. About half of all abortions nationwide are performed using mifepristone as the first of a two-pill regimen. It is also used to help manage miscarriages.
The U.S. Court of Appeals for the 5th Circuit ruled in August that mifepristone — the branded drug Mifeprex and its generic counterpart — can stay on the market in states where abortion is legal, but changes the Food and Drug Administration (FDA) made since 2016 to ease access to the drug were not allowed because the agency did not follow proper procedure.
In a court filing, Solicitor General Elizabeth Prelogar wrote that if the appeals court’s decision is allowed to take effect, “it would upend the regulatory regime for mifepristone, with damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.”
The conservative judges ruled 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.
The case seemingly marks “the first time any court has restricted access to an FDA-approved drug based on disagreement with FDA’s expert judgment about the conditions required to assure that drug’s safe use—much less done so after those conditions had been in effect for years” and millions of people have safely used the drug, Prelogar wrote.
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 case marks the highest stakes legal battle on abortion since the Supreme Court overturned Roe v. Wade last year.
Danco’s attorney Jessica Ellsworth argued 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,” Ellsworth wrote.
“For the women and teenage girls, health care providers, and States that depend on FDA’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously,” she added.
Updated: 6:24 p.m.
