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Justice Dept. asks appeals court to block ruling that imperils access to abortion drug mifepristone

A Trump-appointed judge issued a ruling last week that would suspend the FDA’s longtime approval of mifepristone but delayed his ruling for a week.
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WASHINGTON — The Justice Department filed a request in a federal appeals court Monday seeking to block a ruling last week by a Trump-appointed judge that endangers access to the key abortion pill mifepristone.

The Biden administration asked the 5th U.S. Circuit Court of Appeals to put on hold U.S. District Judge Matthew Kacsmaryk's ruling late last week to allow more time for the case to go through the appeals process.

Danco, the maker of Mifeprex, the brand version of mifepristone, filed a similar request.

The appeals court later asked the plaintiffs in the case to respond soon to the Justice Department’s request.

The administration and Danco argued in court filings that Danco would face significant legal consequences if the Texas order went into effect. Putting the effective date of the drug on hold could cause Danco to go out of business, it claims, because it cannot market or distribute a non-FDA-approved drug.

The company also filed several declarations from doctors who say they couldn’t prescribe mifepristone if the Texas order stands because the drug wouldn’t have FDA approval.

White House press secretary Karine Jean-Pierre said the administration expects the case to work its way to the Supreme Court.

“We feel confident we will win," she told reporters Monday.

Kacsmaryk's ruling "upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe 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 challenging the FDA's approval of the drug in 2000 waited too long to bring its lawsuit and doesn’t have legal standing, the lawyers wrote.

Kacsmaryk's ruling, which is set to go into effect at the end of the week, was "extraordinary and unprecedented," the lawyers added.

The Justice Department asked the appeals court to put an indefinite hold on the decision while the appeals process plays out. If the appeals court doesn’t grant the request, the government's only option would be to ask the Supreme Court to intervene. The government asked the appeals court to act by noon Thursday.

Danco's lawyers said Kacsmaryk's ruling adopted a "one-sided narrative" that "omits crucial facts," including the benefits of the drug for millions of women.

Kacsmaryk, who is based in Amarillo, Texas, issued a ruling Friday that would suspend the FDA's longtime approval of mifepristone — the first of the two-drug regimen used to carry out medication abortions. He granted the plaintiffs a decision that could jeopardize access to mifepristone nationwide. However, he said he would give the federal government a week to appeal before his decision takes effect.

Complicating the situation further, a federal judge in Washington state issued a preliminary injunction in a different case Friday barring the FDA from "altering the status quo and rights as it relates to the availability of mifepristone." That ruling applies only to the 17 liberal-leaning states and Washington, D.C., that sued in February challenging the FDA's regulations over the drug.

Earlier Monday, the Justice Department had filed a motion in federal district court in Washington state asking for clarification of Friday’s ruling telling the FDA to maintain the status quo on mifepristone.

The dueling decisions in Texas and Washington could mean the Supreme Court may soon take up the matter on an accelerated basis.

If Kacsmaryk's ruling in Texas goes into effect, mifepristone could be harder to get in the U.S.

"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 wrote in the most recent filing. "This harm would be felt throughout the country, given that mifepristone has lawful uses in every State. The order would undermine healthcare systems and the reliance interests of businesses and medical providers."

A majority of abortions in the U.S. have been carried out with the use of pills, according to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights.

Meanwhile, the Department of Health and Human Services on Monday walked back Secretary Xavier Becerra’s comments Sunday that the Biden administration could simply ignore the ruling in Texas.

At an event outside Atlanta, Becerra also said Monday that “mifepristone is still legal for use."

"Mifepristone is still available today," he said. "And we are going to do everything we can within the legal process to ensure that that doesn’t change."