The Biden administration on April 10 asked a U.S. appeals court to stop an April 7 order that would make an abortion pill unavailable nationwide.
The FDA approved mifepristone in 2002 and has since allowed it to be dispensed by mail. Many women use it and similar drugs to terminate pregnancies, according to the pro-abortion Guttmacher Institute.
Kacsmaryk’s order temporarily set aside the FDA approval and would have already made the drug unavailable, but he said it wouldn’t take effect for seven days, giving the government time to lodge an appeal.
Government lawyers quickly filed a notice of appeal and on April 10 followed with the emergency request for a stay before the order takes effect.
Not granting the stay would “thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” the lawyers 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 government also asserted that the plaintiffs, a pro-life nonprofit representing nearly 30,000 health care professionals called the Alliance for Hippocratic Medicine and other groups, had presented no evidence they would be injured if a stay were put into place.
The alliance opposes the motion but hasn’t yet filed a response. Plaintiffs have said in court filings that absent an injunction, serious harm would continue to occur.
“The physical and emotional trauma that chemical abortion inflicts on women and girls cannot be reversed or erased. The crucial time that doctors need to treat these injured women and girls cannot be replaced. The mental and monetary costs to these doctors cannot be repaid. And the time, energy, and resources that plaintiff medical associations expend in response to the FDA’s actions on chemical abortion drugs cannot be recovered,” they wrote in a motion for an injunction.
Danco Laboratories, whose sole product is the abortion drug, has filed in support of a stay pending appeal, stating that it will seek relief from the U.S. Supreme Court if necessary.
Another Filing
An order handed down in a different case on the same day as Kacsmaryk’s ruling states that the FDA must keep mifepristone available in 17 states, all led by Democrats, and the District of Columbia.Government defendants “are preliminary enjoined from altering the status or rights of the parties,” U.S. District Judge Thomas Rice, an Obama appointee, wrote in a ruling for a preliminary injunction. He declined to make the injunction nationwide.
The states had asked the court for a ruling affirming the FDA’s conclusion that mifepristone is “safe and effective” and enjoining efforts to remove it from the market.
In an update on April 10, the government asked for clarification in light of the competing rulings.
“If the Texas district court’s order takes effect, the order would—of its own force and without any further action by FDA—stay the effectiveness of FDA’s prior approvals of mifepristone nationwide,” they said. “The result of that order appears to be in significant tension with this Court’s order.”
“The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart,” they added. “To ensure that Defendants comply with all court orders in these unusual circumstances, Defendants respectfully request that this Court clarify their obligations under its preliminary injunction in the event that the Alliance order takes effect and stays the approval of mifepristone.”
Government lawyers also lodged a motion to expedite consideration of the clarification request in light of the looming April 14 enforcement of the order in the other case.
Health and Human Services Secretary Xavier Becerra noted the two rulings in a statement and said that the Department of Health and Human Services was reviewing the decisions.
For the time being, mifepristone remains approved and available, he said.
