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(Trends Wide) — The US Department of Justice will take an emergency dispute over the abortion pill to the Supreme Court, Attorney General Merrick Garland said Thursday.
Garland’s announcement comes after a federal appeals court frozen overnight parts of a Texas judge’s order that would have suspended the Food and Drug Administration’s approval of an abortion drug. of the USA (FDA, for its acronym in English). But the US Court of Appeals for the Fifth Circuit only partially granted the request by the Justice Department and the drug manufacturer to stay US District Judge Matthew Kacsmaryk’s ruling, and the appeals panel effectively made the drug more difficult to obtain by leaving up aspects of the Kacsmaryk decision that will reverse FDA moves that expanded access to medical abortion pills.
In the new statement, Garland indicated that the Justice Department will ask the Supreme Court to now intervene in the emergency dispute over how the FDA has dealt with the drug mifepristone.
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our stay request pending appeal,” Garland said, referring to an appeal ruling that left parts of the judge’s ruling in while it reinstated FDA approval for the drug mifepristone.
He added: “We will seek emergency help from the Supreme Court to uphold the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
Danco Laboratories, a maker of mifepristone that intervened in the case to defend the drug’s approval, also plans to appeal the ruling to the Supreme Court, a lawyer involved told Trends Wide.
The appeals court ordered a return to the FDA’s stricter pre-2016 regimen on the drug, which prevents patients who got it through telehealth or virtual visits with their providers instead of traveling to a clinic from mailing the pill. or hospital in person to get the pill.
The restrictions also affect the instructions on the drug’s label, shortening the window to get the pill to seven weeks into the pregnancy instead of 10. However, it is possible that, even with the ruling in place, some providers could “go off-label.” ” and continue prescribing mifepristone until 10 weeks. Mifepristone is one of the drugs used to abort instead of accessing surgery.
Steve Vladeck, a Trends Wide Supreme Court analyst and professor at the University of Texas Law School, said the ruling “froze the craziest and most damaging parts of the Kacsmaryk ruling” but that access to mifepristone is still limited. significantly limited.
“The panel ruled that the 2000 mifepristone approval challenge was likely time-barred, so it froze that part of the ruling.” wrote on Twitter. “But it *didn’t* freeze the Kacsmaryk block from the 2016 and 2021 revisions that (1) make mifepristone available for up to 10 weeks; and (2) by mail.”
Medical abortion, which makes up the majority of abortions performed in the United States, has emerged as a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year struck down Roe v. Wade who protected abortion rights nationwide.
Last Friday, Kacsmaryk issued a ruling that would have revoked the FDA’s approval of the drug mifepristone, approved 23 years ago. Under the new appeals court order, the approval will remain in effect and the drug will remain on the market while an expedited appeal is developed.
In issuing his ruling last week, Kacsmaryk delayed its entry into force by seven days to give the government time to appeal.
In November, doctors and anti-abortion plaintiffs filed the lawsuit challenging the FDA’s approval of the drug in 2000 and pointing out how the agency has since changed the rules about its use in ways that have made the pill easier to use. obtain.
A 5th Circuit split panel said in its new order that it would reinstate the drug’s approval due to certain procedural hurdles plaintiffs face in challenging it. But the appeals court said abortion pill advocates had failed to show they were likely to defeat the plaintiffs’ claims against the FDA’s latest regulatory action on mifepristone.
The appeal order was issued by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign some aspects of the order.
The judge said she would have granted the expedited appeal but would have issued an administrative stay of Kacmsaryk’s ruling, a temporary stay that would have lasted for a “brief period of time,” and deferred the question of whether it should be frozen any longer, and adjourned the question of whether it should be frozen for a longer period for the judges to hear the expedited appeal.
That panel will have a different composition from the panel that considered the DOJ and Danco’s request that the ruling be halted in the interim.
Much of the 42-page order from the Fifth Circuit was devoted to analyzing whether the plaintiffs face procedural problems in presenting their case. The appeals court sympathized with much of the plaintiffs’ claims about the drug’s safety, which have been rebuked by major medical associations.
The 5th Circuit said the FDA’s current rules on the drug created “an extremely unusual regimen” because the agency “chose to exclude physicians from prescribing and administering mifepristone.”
“In fact, to the best of the record before us, the FDA has not structured the distribution of any comparable drug in this way,” the panel said.
The FDA approved mifepristone after a four-year review process. It has proven to be a safe and effective way to terminate a pregnancy in the more than two decades that it has been on the market. But anti-abortion doctors and medical associations allege the agency violated the law by failing to adequately take into account the drug’s alleged risks.
Federal judge doubles down on separate dispute
Meanwhile, a federal judge in Washington state made it clear Thursday that the FDA must comply with its previous order barring the agency from taking action to reduce the availability of the abortion drug in 17 states and the District of Columbia.
Judge Thomas O. Rice’s order last week applied to the 18 Democratic-led jurisdictions that filed a separate lawsuit to expand access to mifepristone. But it seemed to conflict with Kacsmaryk’s order that would have suspended FDA approval of the drug nationwide.
The Biden administration asked the Washington judge on Monday to clarify how to comply with his ruling and that of Texas. The Fifth Circuit then partially blocked Kacsmaryk’s ruling in the Texas case, which now heads to the Supreme Court.
In her response Thursday, Rice doubled down on her efforts, citing the Fifth Circuit’s order and telling the government that because her court “has jurisdiction over the parties before it and limited its preliminary injunction to only the plaintiff states and the District of Columbia, this preliminary injunction of the Court became effective on April 7, 2023, and must be complied with by defendants.”
— Vogue’s Ariane and Trends Wide’s Devan Cole contributed to this report.
