Drugmaker, DOJ Ask Supreme Court to Block Ruling Against Abortion Pill
The company that makes a widely used abortion drug asked the U.S. Supreme Court on April 14 to block a recent ruling that limits the drug’s availability, as did the U.S. Department of Justice (DOJ).
Danco Laboratories manufactures mifepristone, used by many women to terminate pregnancies. Under an appeals court ruling this week, the drug cannot be prescribed by mail. A separate ruling in a different court ordered no new limits on mifepristone in 17 states.
The competing rulings have resulted in “an untenable limbo, for Danco, for providers, for women, and for health care systems all trying to navigate these uncharted waters,” Danco said in a filing to the Supreme Court.
The company said the court should block the ruling that limits access to mifepristone the U.S. Court of Appeals for the Fifth Circuit entered.
“Leaving the Fifth Circuit’s ruling in place will irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under [federal law] nationwide,” the request for a stay stated. “The lack of emergency relief from this Court will also harm women, the health care system, the pharmaceutical industry, States’ sovereignty interests, and the separation of powers.”
The DOJ also asked the nation’s top court to step in.
“This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” Solicitor General Elizabeth Prelogar wrote in a filing.
At least five justices would need to approve the requests for a stay on the lower court ruling to be entered.
The Alliance Defending Freedom, which is representing groups that challenged the U.S. Food and Drug Administration (FDA) approval of mifepristone, said that the Supreme Court should turn down the new requests.
“The FDA illegally approved chemical abortion drugs and has evaded its legal responsibility to answer the American people’s questions for two decades,” Erin Hawley, an alliance lawyer, said in a statement. “The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place.”
Background
Mifepristone was approved by the FDA in 2000, with some limitations. Starting in 2016, the agency rolled back many limitations, including revoking the requirement to be prescribed in person.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ruled this month that the FDA had to halt its approval because of signs the agency violated its statutory duty in evaluating the drug’s safety.
He said the order would not be imposed for a week, giving the government time to appeal.
An appeal partially overturned the order. A panel of appeals court judges said that the government had made a strong case regarding Kacsmaryk’s order as it pertained to the drug approval. But the government did not show that the FDA’s actions from 2016 “were not arbitrary and capricious,” the judges said.
The panel that ruled consisted of Circuit Court Judges Catharina Haynes, a George W. Bush appointee; Kyle Engelhardt, a Trump appointee; and Andrew Oldham, a Trump appointee.
