A federal appeals court decision that declined to suspend approval of the abortion pill mifepristone but kept in place restrictions that would prevent it from being sent to patients by mail has teed up a high-stakes showdown at the Supreme Court.
Attorney General Merrick Garland said Thursday that the Justice Department “strongly disagrees” with the 5th U.S. Circuit Court of Appeals' decision to allow the restrictions and will seek immediate Supreme Court review.
The decision late Wednesday by the New Orleans-based appeals court leaves considerable uncertainty over access to the drug.
The Biden administration would need to win the votes of at least five of the nine justices on the Supreme Court, which has a 6-3 conservative majority.
The appeals court granted the Justice Department's emergency request to put on hold part of U.S. District Judge Matthew Kacsmaryk's decision last week that suspended the Food and Drug Administration's original approval of mifepristone, which dates to 2000.
But the three-judge panel said a separate part of Kacsmaryk's decision, which suspends changes the FDA made to the drug's approved use in 2016, could go into effect. The panel also determined that the FDA's finding in 2021 that mifepristone can be distributed by mail should be put on hold, as well as the 2019 decision that approved a generic version of mifepristone made by GenBioPro.
The court's decision imperils widespread availability of the drug, as it would require patients to make in-person visits to obtain it.
The 2016 changes, among other things, reduced the number of in-person visits patients are required to make from three to one and allowed the pills to be prescribed to women at up to 10 weeks' gestation instead of up to seven weeks.
Erin Hawley, a lawyer with Alliance Defending Freedom, a conservative Christian legal group that represents the challengers, said in a statement that the appeals court’s decision to allow new restrictions was “a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law.”
Abortion rights groups assailed the appeals court for failing to block Kacsmaryk's ruling in full.
"Anti-choice extremists want to ban all abortion, everywhere. They can’t win elections, so they’ve turned to the courts to do their dirty work," Mini Timmaraju, the president of NARAL Pro-Choice America, said in a statement.
The Supreme Court, in a 5-4 ruling last summer, overturned the landmark Roe v. Wade ruling, which guaranteed a constitutional right to abortion. The new case raises different legal issues about the FDA’s process for approving drugs, but it will nevertheless put to the test the court’s pledge last year that it would leave abortion policy to the states and the federal government.
The appeals court panel was divided 2-1, with Judges Kurt Engelhardt and Andrew Oldham, both appointees of President Donald Trump, in the majority. Judge Catharina Haynes, an appointee of President George W. Bush, said she would have temporarily blocked the ruling in full.
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The appeals court concluded that the challengers had waited too long to challenge the 2000 approval. But, the court found, the claims against the 2016 revisions and later decisions could be pursued because the government and drugmaker Danco Laboratories "have not shown that plaintiffs 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 Act, which prohibits the mailing of any drug or medicine that can be used for abortion, factors into its analysis of the 2021 decision to allow mifepristone to be distributed by mail.
The Biden administration and Danco, the maker of Mifeprex, the brand version of mifepristone, are seeking to block Kacsmaryk’s ruling in full.
Complicating the situation further, a federal judge in Washington state issued a preliminary injunction in a different case last week barring the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”
The ruling applies only to the 17 liberal-leaning states and the District of Columbia that filed a lawsuit in February challenging the FDA’s regulations over the drug.
At the request of the Justice Department, U.S. District Judge Thomas Rice in Washington state clarified in an order Thursday that the FDA cannot make any moves to comply with the 5th Circuit's decision in the states affected by the case before him.
His order made clear the direct conflict between the rulings, which is likely to factor into the Supreme Court's consideration of the issue.
While misoprostol can be used alone for abortions, experts have said it is not as effective at terminating pregnancies as it is in tandem with mifepristone.
A majority of abortions in the U.S. are carried out using pills, according to a survey by the Guttmacher Institute, a research group that supports abortion rights.