Justice Department asks appeals court to pause "extraordinary and unprecedented" abortion pill ruling

Washington — The Justice Department on Monday formally asked a federal appeals court to put on hold an order from a U.S. district court judge that halted the Food and Drug Administration's (FDA) approval of the abortion pill, calling the ruling "extraordinary and unprecedented."

The Biden administration is appealing Friday's ruling from U.S. District Judge Matthew Kacsmaryk and requested the U.S. Court of Appeals for the 5th Circuit to freeze his decision while proceedings continue. 

"The district court's extraordinary and unprecedented order should be stayed pending appeal," Justice Department lawyers wrote in their filing to the 5th Circuit, indicating that they're prepared to seek relief from the Supreme Court if necessary.

The Biden administration argued that the November legal challenge to the FDA's 2000 approval of mifepristone is "manifestly untimely" and said the group of anti-abortion rights physicians and medical associations that targeted access to the drug lack the legal standing to challenge the FDA's approval of mifepristone, which they neither take nor prescribe.

"The court's sweeping nationwide relief was especially unwarranted given the balance of harms: If allowed to take effect, the court's order would thwart FDA's scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity," the Justice Department said. "This harm would be felt throughout the country, given that mifepristone has lawful uses in every state. The order would undermine healthcare systems and the reliance interests of businesses and medical providers."

The Biden administration acted swiftly in response to Kacsmaryk's decision, which blocked the FDA's approval of mifepristone. The judge, appointed by former President Donald Trump, put his ruling on hold until Friday to allow the Justice Department time to appeal, and the Justice Department asked the 5th Circuit to respond to its request for a stay by noon on Thursday.

While not unexpected, Kacsmaryk's decision dealt a blow to abortion rights advocates fighting to protect abortion rights in the wake of the Supreme Court's decision last year overturning Roe v. Wade.

And while he stopped short of withdrawing the FDA's approval of mifepristone, which the medical groups had requested, the decision risks cutting off access to one of the most commonly used methods of abortion after more than a dozen states imposed restrictions or outright bans in the last nine months. 

Further complicating the legal landscape is a separate decision from a federal district judge in Washington, also issued Friday, that blocks the FDA from altering the status quo with regards to mifepristone's availability in 16 states and the District of Columbia. Those states and D.C. sued the Biden administration in February over a set of restrictions imposed on the drug and sought to preserve access to it.

The Justice Department has sought clarification from that court as to its obligations under the order.

The FDA approved mifepristone in 2000, and the drug is taken together with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation. Since then, the agency has made several changes to the rules surrounding the abortion pill, including approving a generic version of mifepristone in 2019 and lifting a requirement that the pills be dispensed in-person in 2021, which allowed the drug to be prescribed by a provider during telemedicine appointments and sent by mail.

Medication abortions accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention, and the Biden administration told the 5th Circuit that serious adverse events are rare when mifepristone is used as directed by the FDA. More than 5 million women have take mifepristone since 2000, and only 28 deaths were reported through June 2022, though some were associated were "obvious alternative causes" unrelated to use of the abortion pill, according to the FDA.

"The court upended the status quo with its abrupt and sweeping nationwide order," the Biden administration said. "If allowed to take effect, that order will irreparably harm patients, healthcare systems, and businesses."

In addition to warning of the negative impacts the order could have on patients seeking abortions, the Justice Department said it could harm "patients, their families, and providers by overburdening healthcare systems, leading to long waits for care in a system with limited resources."

Joining the Biden administration is seeking a stay from the 5th Circuit is Danco Laboratories, the maker of mifepristone that submitted the original application for its approval to the FDA in 1996. Danco sells only one product, Mifeprex (mifepristone), and warned that it may be unable to continue operating if Kacsmaryk's injunction remains in effect.

"The decision below is an extreme outlier: No court has ever 'stayed' or 'suspended' the longstanding approval of a drug consistently found safe and effective by FDA," Danco wrote in its own request for the 5th Circuit to pause the district court's order. "The court's mandatory injunction is an unprecedented judicial assault on a careful regulatory process that has served the public for decades."