A federal appeals court late Wednesday blocked a part of a ruling issued last week by a Trump-appointed judge that endangers access to the abortion pill mifepristone, with the choice leaving considerable uncertainty over access to the drug.
The fifth U.S. Circuit Court of Appeals granted the Justice Department’s emergency request to placed on hold the a part of the choice issued by U.S. District Judge Matthew Kacsmaryk that suspended the Food and Drug Administration’s original approval of mifepristone, which dates to 2000.
However the three-judge panel said a separate a 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 agency’s finding in 2021 that mifepristone will be distributed by mail can be paused, as well, as Kacsmaryk ordered.
The court’s decision imperils widespread availability of the drug, as it will require patients to make in-person visits to acquire it.
The 2016 changes, amongst other things, reduced the variety of in-person visits that patients are required to make from three to at least one and allowed the pills to be prescribed to women at as much as 10 weeks’ gestation as a substitute of as much as seven weeks.
The appeals court said it will expedite its full consideration of the case.
The Justice Department can still ask the Supreme Court to intervene in an try and completely block Kacsmaryk’s ruling. The administration would want to win the votes of a minimum of five of the nine justices on the court, which has a 6-3 conservative majority.
The appeals court panel was divided 2-1, with Judges Kurt Engelhardt and Andrew Oldham, each appointees of President Donald Trump, in the bulk. Judge Catharina Haynes, an appointee of President George W. Bush, said she would have temporarily blocked the ruling in full.
The appeals court concluded that the challengers had waited too long to challenge the 2000 approval in court. But, the court found, the claims against the 2016 revisions and later decisions might be pursued because the federal government and drug maker Danco Laboratories “haven’t shown that plaintiffs are unlikely to succeed on the merits of their timely challenges.”
The court also found that a hitherto obscure nineteenth century law called the Comstock Act, which prohibits the mailing of any drug or medicine that will be used for abortion, aspects into its evaluation of the 2021 decision to permit mifepristone to be distributed by mail.
“To the extent the Comstock Act introduces uncertainty into the last word merits of the case, that uncertainty favors the plaintiffs,” the court said.
The Biden administration and Danco, the maker of Mifeprex, the brand version of mifepristone, each filed requests to place Kacsmaryk’s ruling on hold.
Kacsmaryk’s decision “upended many years of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this secure and effective treatment, based on the court’s own misguided assessment of the drug’s safety,” Justice Department lawyers wrote in court papers.
The anti-abortion coalition difficult the FDA’s approval of the drug in 2000, called the Alliance of Hippocratic Medicine, waited too long to bring its lawsuit and doesn’t have legal standing to accomplish that, the lawyers wrote.
Danco’s lawyers said Kacsmaryk’s ruling adopted a “one-sided narrative” that “omits crucial facts,” including the advantages of the drug to hundreds of thousands of ladies.
Those difficult the drug’s approval said in court papers that a call in favor of the federal government would “perpetuate FDA’s illegal mail order abortion regime and lead to further harms from a dangerous drug the district court found should never have been approved.”
If the ruling issued Friday goes into effect in full, it will suspend the FDA’s longtime approval of mifepristone — the primary drug within the two-drug regimen used to perform medicated abortions. That will jeopardize access to mifepristone nationwide. Nevertheless, Kacsmaryk gave the federal government per week to appeal his decision before it takes effect.
“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 lawyers wrote in essentially the most recent filing. “This harm can be felt throughout the country, provided that mifepristone has lawful uses in every State. The order would undermine healthcare systems and the reliance interests of companies and medical providers.”
Complicating the situation further, a federal judge in Washington state issued a preliminary injunction in a unique case Friday barring the FDA from “altering the established order and rights because it pertains to the provision of mifepristone.”
That ruling applies only to the 17 liberal-leaning states and the District of Columbia that filed a lawsuit in February difficult the FDA’s regulations over the drug. The Justice Department has filed a motion in federal district court in Washington state, asking for clarification of Friday’s ruling.
The dueling decisions in Texas and Washington could mean the Supreme Court, which last summer overturned the landmark Roe v. Wade ruling, may soon take up the matter on an accelerated basis.
Kacsmaryk’s ruling, whether it is allowed to face, wouldn’t mean access to mifepristone would immediately be cut off nationwide. As an alternative, anyone involved in manufacturing, distributing or prescribing it will face legal risk, said Greer Donley, a professor on the University of Pittsburgh School of Law who focuses on reproductive rights.
The FDA could help alleviate that risk by announcing it will not take enforcement motion against anyone involved in distributing the drug, she added. The agency has broad power to accomplish that, with the Supreme Court in a 1985 ruling saying that such decisions generally can’t be challenged in court.
While misoprostol will be used alone for abortions, experts have said it just isn’t as effective in terminating pregnancies because it is in tandem with mifepristone.
A majority of abortions within the U.S. are carried out with using pills, in response to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights.
