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Justice Department and abortion pill manufacturer ask appeals court to freeze judge’s order that could make drug unavailable after Friday

<i>Evelyn Hockstein/Reuters/File</i><br/>A patient prepares to take mifepristone
Evelyn Hockstein/Reuters/File
A patient prepares to take mifepristone

By Tierney Sneed and Ariane de Vogue, CNN

The Justice Department and a manufacturer of medication abortion drugs asked a federal appeals court on Monday to put on hold a judge’s ruling that could make the drug unavailable nationwide after Friday.

The requests, filed on Monday before the US 5th Circuit Court of Appeals, are seeking a short-term administrative stay as well as a long-term stay pending appeal on a lower court ruling from US District Judge Matthew Kacsmaryk, who ordered the Food and Drug Administration’s approval of the drug to be suspended. The court said Monday that the plaintiffs in the case must respond by Tuesday night before midnight.

An administrative stay would give the appellate court more breathing room to consider whether Kacsmaryk’s ruling should be frozen while the litigation plays out. The Justice Department and Danco, a manufacturer of the drug mifepristone that intervened in the case to defend the FDA’s approval in 2000, had both already filed notices of appeal.

Kacsmaryk said his Friday night order would not go into effect for seven days to give the Justice Department time to appeal.

The Justice Department is asking for the 5th Circuit to act on its emergency request by noon on Thursday, “to enable the government to seek relief in the Supreme Court if necessary.”

The department’s lawyers told the appeals court that if Kacsmaryk’s ruling were to go into effect, it “would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”

“This harm would be felt throughout the country, given that mifepristone has lawful uses in every State,” the DOJ filing said. “The order would undermine healthcare systems and the reliance interests of businesses and medical providers. In contrast, plaintiffs present no evidence that they will be injured at all, much less irreparably harmed, by maintaining the status quo they left unchallenged for years.”

Danco similarly told the appeals court that if Kacsmaryk’s order wasn’t frozen, it “is certain to cause irreparable harm: to women who will lose access to the medication abortion regimen that is the standard of care; to Danco; to the pharmaceutical and biotechnology industries; and to the separation of powers undergirding judicial and regulatory action.”

Kacsmaryk’s order in a case brought in Texas by anti-abortion rights activists is seemingly at odds with another federal court ruling handed down less than an hour later in a separate case on the other side of the country.

That second order said that the FDA must maintain the drug’s availability in 17 Democratic-led states and the District of Columbia, which sued to make abortion pills easier to obtain. In that case, US District Judge Thomas O. Rice said the FDA could not do anything that would reduce the availability of the drug in the 18 jurisdictions that brought the lawsuit.

The Justice Department has not said yet whether it will appeal Rice’s order. On Monday, the Justice Department asked Rice to clarify how FDA should comply with his order if Kacsmaryk’s ruling is allowed to go into effect, with a filing that pointed to a “significant tension” between the two rulings.

Mifepristone is the first pill in the two-pill process to terminate a pregnancy. Medication abortion makes up the majority of abortions in the United States.

With its latest 5th Circuit filing, the Justice Department argued that the district court upended the FDA’s approval of mifepristone, “depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”

“The district court took this extraordinary step despite the fact that plaintiffs did not seek relief for many years after mifepristone’s original approval, waited nearly a year after the most recent FDA actions they seek to challenge, and then asked the court to defer any relief until after a final resolution of the case,” the DOJ wrote.

The Justice Department described Kacsmaryk’s order as “extraordinary and unprecedented.”

Meanwhile, Danco characterized the Friday ruling as “an unprecedented judicial assault on a careful regulatory process that has served the public for decades.”

Declarations from prominent doctors

Danco’s filing included declarations from two prominent doctors who have sworn under oath about the safety of mifepristone and warn that their patients will be “irreparably harmed” if the district court order is allowed to go into effect.

One declaration comes from Dr. Courtney Schreiber, a professor in the Department of Obstetrics and Gynecology at the University of Pennsylvania.

She said that some patients are unable to have procedural abortion — the other method of terminating a pregnancy — due to their anatomy and that others may have to weigh whether to have a “re-traumatizing pelvic exam” and procedure or continue an “unwanted pregnancy as a result of rape to term.”

Schreiber underscored that some of her patients will believe that “abortion is no longer available or unsafe.”

Some facilities, she said, may offer just misoprostol, a second medication drug that usually works in concert with mifepristone. Such a move would “surely result in more unscheduled visits and emergency room visits for pain, incomplete abortion, and side-effect concerns,” she said.

“Restricted access to this safe therapeutic threatens the health of real people — people who are mothers, sisters, daughters, wives and friends — in our country,” Schreiber said.

Another declaration was signed by Alisa Goldberg, the director of the Family Planning Fellowship and Associate Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School. She is currently an attending physician at Brigham and Women’s Hospital in Boston and has prescribed mifepristone through the Planned Parenthood League of Massachusetts.

Goldberg says she “personally” prescribes mifepristone to approximately 10 patients a month, all of whom she sees in-person. She says she has tracked adverse events due to mifepristone and that less than 1% of patients report any sort of serious adverse event from a medication abortion.

She said that surgical abortions are less available, in part, because the procedure requires an appropriate space, a team including a doctor, multiple nurses and medical assistants, and typically a three-to-four hour visit.

“I am concerned that if a stay is not issued, more of my patients likely will end up unable to obtain necessary and desired reproductive health care in a timely fashion,” Goldberg said.

This story and headline have been updated with additional developments.

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