WASHINGTON — A maker of the abortion drug mifepristone asked the Supreme Court Friday to block part of a court decision that prevents pregnant women from getting the pill by mail.
Danco Laboratories urged the court, which has a 6-3 conservative majority, to effectively stay the entirety of a decision handed down by Texas-based U.S. District Judge Matthew Kacsmaryk that awarded a landslide victory to abortion opponents. .
The company, which makes Mifeprex, the brand-name version of the drug, said it would be “irreparably harmed” if the decision goes into effect because it “will not be able to conduct its business domestically and comply with its legal obligations.”
Danco said the court should immediately block Kacsmaryk’s ruling in its entirety while it considers what steps to take, weighing whether to quickly hear oral arguments and expeditiously issue a full ruling.
The Biden administration is also ready to ask the Supreme Court to intervene.
On Wednesday night, the US Court of Appeals for the Fifth Circuit handed the Food and Drug Administration a partial victory by refusing to suspend the original FDA approval of mifepristone in 2000, which would have made it illegal. the distribution of the drug.
But the court allowed separate elements of the Kacsmaryk decision to stand, including the prohibition on obtaining the drug by mail, which is what the Justice Department is challenging in Supreme Court.
The administration would need to win the votes of at least five of the nine justices on the court, which last summer in a 5-4 ruling overturned the landmark Roe v. Wade who said that women have the right to have an abortion.
The new case raises a number of legal issues related to the FDA’s drug approval process, but will nonetheless test a court’s promise last year to leave abortion policy to states and the federal government.
The appeals court decision, if upheld, jeopardizes the drug’s widespread availability, as it would require patients to make in-person visits to obtain it. The three-judge panel said part of Kacsmaryk’s decision suspending changes the FDA made to the drug’s approved use in 2016 could take effect; it also ruled that the agency’s 2021 determination that mifepristone can be distributed by mail order should be suspended, as well as the 2019 decision that approved a generic version of mifepristone, which is made by GenBioPro.
The 2016 changes, among other things, reduced the number of in-person visits patients must make from three to one and allowed the pills to be prescribed to women up to 10 weeks pregnant instead of up to seven weeks.
The appeals court concluded that the challengers had waited too long to challenge the approval of 2000 in court. But the court found that claims against the 2016 reviews and subsequent decisions could continue because the government and Danco “have not demonstrated that the claimants are unlikely to succeed on the merits of their timely challenges.”
The court also found that a hitherto obscure 19th-century law called the Comstock Law, which prohibits the mailing of any drug or medicine that can be used for abortion, is a factor in its analysis of the 2021 decision to allow the mifepristone is distributed by mail.
To further complicate matters, a federal judge in Washington state issued a preliminary injunction in a different case on Friday that prohibited the FDA from “disturbing the status quo and rights regarding the availability of mifepristone.”
That ruling applies only to the 17 liberal-leaning states and the District of Columbia that filed a lawsuit in February challenging FDA regulations on the drug. The Justice Department filed a motion in federal district court in Washington state, seeking clarification on Friday’s ruling.
Although a different drug, misoprostol, can be used alone for abortions, experts have said that it is not as effective at terminating pregnancies as when given together with mifepristone.
Most abortions in the US are performed with the use of pills, according to a survey by the Guttmacher Institutea research group that supports abortion rights.
