CNN
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The Justice Department and an abortion drug maker on Monday asked a federal appeals court to stay a judge’s ruling that could make the drug unavailable nationwide starting midnight Friday.
The applications, filed Monday in the United States Court of Appeals for the 5th Circuit, seek a short-term administrative stay as well as a long-term stay pending appeal of a lower court ruling by Judge US District Secretary Matthew Kacsmaryk, who ordered the food and drug administration’s approval to be suspended.
An administrative stay would give the appeals court more leeway to determine whether Kacsmaryk’s decision should be frozen while the litigation unfolds. Both the Justice Department and Danco, a maker of the mifepristone drug that intervened in the case to defend FDA approval in 2000, had previously 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 the 5th Circuit to act on its emergency request by noon Thursday, “to allow the government to seek relief from the Supreme Court if necessary.”
Lawyers for the department told the appeals court that if Kacsmaryk’s decision were to go into effect, it would “contrary the scientific judgment of the FDA and seriously harm women, especially those for whom mifepristone is a medical necessity.” or practical”.
“This harm would be felt nationwide, given that mifepristone has legal uses in all states,” the DOJ filing said. “The order would undermine healthcare systems and the dependency interests of businesses and medical providers. In contrast, plaintiffs present no evidence that they will be harmed at all, much less irreparably harmed, by maintaining the status quo they have not challenged for years.
Danco also told the appeals court that if Kacmsaryk’s order is not frozen, it “will certainly cause irreparable harm: to women who will lose access to the medical abortion regimen that is the standard of care ; to Danco; the pharmaceutical and biotechnology industries; and the separation of powers that underpins judicial and regulatory action.
Kacsmaryk’s order in a case brought in Texas by anti-abortion activists apparently contradicts another federal court decision issued less than an hour later in a separate case across the country.
That second order said the FDA must keep the drug available in 17 Democrat-led states and the District of Columbia, which filed a lawsuit to make it easier to get abortion pills. In that case, U.S. District Judge Thomas O. Rice said there was nothing the FDA could do that would reduce the availability of the drug in the 18 jurisdictions that filed the lawsuit.
The Justice Department has not yet said whether it will appeal Rice’s order. On Monday, the Justice Department asked Rice to clarify how the FDA would have to comply with its order if Kacsmaryk’s ruling was allowed to go into effect, with a filing that indicated “significant tension” between the two rulings.
Mifepristone is the first pill in the two-pill process to terminate a pregnancy. Medical abortion constitutes the majority of abortions in the United States.
With its latest 5th Circuit filing, the Justice Department argued that the District Court overruled the FDA’s approval of mifepristone, “depriving patients of access to this safe and effective treatment, on the basis of the tribunal’s own erroneous assessment of the safety of the drug”.
“The District Court took this extraordinary step despite the fact that the plaintiffs did not seek relief for many years after the initial approval of mifepristone, waited nearly a year after the most recent actions of the FDA they seek to challenge, then asked the court to defer any relief until after a final resolution of the case,” the DOJ wrote.
The Justice Department called Kacsmaryk’s order “extraordinary and unprecedented.”
Meanwhile, Danco called Friday’s decision “an unprecedented legal assault on a painstaking regulatory process that has served the public for decades.”
Danco’s filing included statements from two prominent physicians who have been sworn 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.
A statement comes from Dr. Courtney Schreiber, a professor in the Department of Obstetrics and Gynecology at the University of Pennsylvania.
She said some patients could not have a procedural abortion – the other method of terminating a pregnancy – because of their anatomy and others may have to weigh whether to undergo a “traumatic pelvic exam” and a procedure or to pursue an “unintended pregnancy”. following a term rape.
Schreiber pointed out that some of his patients will believe that “abortion is no longer available or unsafe.”
Some facilities, she said, may only offer misoprostol, a second drug that usually works in concert with mifepristone. Such a move would “surely lead to more unscheduled visits and emergency room visits for pain, incomplete abortion and side effect issues,” she said.
“Restricted access to this safe therapy threatens the health of real people — people who are mothers, sisters, daughters, wives and friends — in our country,” Schreiber said.
Another statement was signed by Alisa Goldberg, 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 about 10 patients a month, all of whom she sees in person. She says she has tracked adverse events due to mifepristone and less than 1% of patients report any type of serious adverse event related to medical abortion.
She said surgical abortions are less available, in part because the procedure requires proper space, a team that includes a doctor, several nurses and medical assistants, and typically a three- to four-hour visit.
“I fear that if a reprieve is not granted, more of my patients will likely find themselves unable to obtain needed and desired reproductive health care in a timely manner,” Goldberg said.
This story and title have been updated with additional developments.
