DOJ, abortion pill maker file briefs urging Supreme Court to reverse abortion pill ruling

The U.S. Department of Justice this week filed a legal brief urging the Supreme Court to overturn a lower court decision that would limit access to the abortion pill mifepristone. The brief argued that the ruling would disrupt the authority of the Food and Drug Administration and harm the U.S. health-care system.

“The loss of access to mifepristone would be damaging for women and health-care providers around the nation,” Solicitor General Elizabeth Prelogar wrote in the brief. “For many patients, mifepristone is the best method to lawfully terminate their early pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy or past trauma.”

In a separate brief, lawyers for the drugmaker, Danco, said the questions raised in the case “are not hard under existing precedent” and “do not ask the court to wade into a politically charged debate around abortion.” The appeals court ruling under review “threatens to destabilize the pharmaceutical industry, which relies both on FDA’s ability to make predictive judgments and on courts not second-guessing those scientific judgments,” the lawyers wrote.

Last August, the New Orleans-based 5th U.S. Circuit Court of Appeals barred telemedicine prescriptions and shipments by mail of the drug. The challenge to mifepristone approval was brought by a group of doctors and other medical professionals who said the FDA’s approval in 2000 was flawed, as were later decisions that made the drug easier to access, in part because they failed to take into account safety risks to women. The FDA has called the drug safe and effective, as demonstrated over its decades of use by millions of American women.

The high court agreed last month to hear the Biden administration’s appeal of that decision in 2024. The Supreme Court will focus on FDA actions from 2016 onward that made it easier to access the pill, including the initial 2021 decision that made it available by mail, which was finalized last year.

Also under review are the 2016 decisions to extend the window in which mifepristone could be used to terminate pregnancies from seven weeks’ gestation to 10 weeks and reduce the number of in-person visits for patients from three to one. In another 2016 move, the FDA altered the dosing regimen, finding that a lower dose of mifepristone was sufficient.

Related: Supreme Court agrees to hear ‘abortion pill access’ case (in election year)

Mifepristone remains available under a Supreme Court order maintaining the status quo, pending the outcome of legal challenges. The court’s eventual ruling in the case is expected by the end of June.