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.
The Biden administration argued that the legal challenge to the FDA’s approval of mifepristone more than 20 years ago is “manifestly untimely” and said the group of physician 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.
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 have become more common over the years, accounting for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention. The American College of Obstetricians and Gynecologists notes medication abortion has been used by over 3 million women in the U.S. since FDA approval in 2000, and says it is “safe and effective.”
