The Justice Department on Friday filed an emergency appeal with the Supreme Court asking the justices to undo a lower court ruling that blocks the Food and Drug Administration’s approval of the abortion pill mifepristone.
The Biden administration said the justices should block the order from Texas District Judge Matthew J. Kacsmaryk because it undermines science and is creating chaos, noting a separate district court in Washington that approved the FDA’s regulation of mifepristone.
“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,” wrote Solicitor General Elizabeth Prelogar.
The government’s appeal was filed on the same day that Danco Laboratories, a producer of the abortion pill mifepristone, asked the Supreme Court to block the Texas ruling and take up the legal challenge over whether the drug can lawfully be distributed across the country.
Danco says it cannot lawfully distribute its drug after the 5th U.S. Circuit Court of Appeals this week limited its use, cutting back on some of the regulations issued by the FDA in 2016.
The 5th Circuit ruled that the drug cannot be sent via the mail and can be used up to seven weeks into pregnancy, instead of the FDA-approved 10 weeks.
The Eastern District of Washington, however, last Friday issued a separate order in a different lawsuit over the drug, saying the FDA’s authorization of mifepristone is legal, greenlighting the abortion pill’s production and distribution.
“The result is an untenable limbo, for Danco, for providers, for women and for health care systems all trying to navigate these uncharted waters,” the drug company argued in its filing.
The battle over the abortion drug enraged supporters of abortion access after Judge Kacsmaryk, a Trump appointee, last Friday said the FDA’s approval of mifepristone was unlawful.
He ruled the FDA could not continue to approve the pill in a case brought by pro-life advocates and physicians who argued that women have had grave health consequences from using the pill.
Judge Kacsmaryk said in his decision that the court “does not second-guess FDA’s decision-making lightly.”
“But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
Just before midnight on Wednesday, the 5th U.S. Circuit Court of Appeals disagreed in a 2-1 ruling.
Two of the judges, Judge Kurt Engelhardt and Judge Andrew Oldham, were Trump appointees. Judge Catharina Haynes, a Bush appointee, said she would expedite the case for oral arguments but put the lower court block on hold entirely.
The circuit court’s ruling said the drug could still be dispensed — but not through the mail as regulators had begun to allow in 2016, and only up to seven weeks into pregnancy.
“Mifepristone users who present themselves to the plaintiffs have required blood transfusions, overnight hospitalization, intensive care, and even surgical abortions,” the three-judge panel wrote in the ruling. “As a result of FDA’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects.”
The drug was originally approved in 2000 for up to seven weeks of pregnancy. But it was not sent through the mail. It required three steps: first a visit with a doctor to receive the mifepristone, and then another one to get the misoprostol. There was also routinely a third visit with a doctor to address complications, according to The Associated Press.
If the appeals court order remains in place, those three steps would be required for the abortion pill to be given.
• Alex Swoyer can be reached at aswoyer@washingtontimes.com.
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