The Department of Justice filed an emergency motion with a federal appeals court to stop a judge’s judgment last week that would ban countrywide access to the abortion medication mifepristone.
On Friday, Trump-appointed U.S. District Judge Matthew Kacsmaryk halted the FDA’s clearance of mifepristone, which is taken with misoprostol to terminate a pregnancy within 70 days. Kacsmaryk gave the federal government seven days to ask the Fifth Circuit for emergency relief.
Failed to get mifepristone approved by the FDA
Monday’s Justice Department appeal termed that ruling extraordinary and exceptional.
Lawyers requested the appeals court stay Kacsmaryk’s ruling while the case proceeds.
The Supreme Court, which reversed Roe V. Wade and reinstated abortion restrictions to states last year, may hear it.
In reaction to Kacsmaryk’s ruling, which prevented the FDA from approving mifepristone, the Biden administration moved quickly.
To give the Justice Department time to file an appeal, the judge, who was selected by the previous president Donald Trump, delayed his decision until Friday.
The Justice Department requested a response from the 5th Circuit on its request for a stay by noon on Wednesday.
Despite being predicted, Kacsmaryk’s decision was a setback for proponents of abortion rights who had been fighting to defend such rights after the Supreme Court’s ruling last year overturning Roe v. Wade.
And although Obama refrained from rescinding the FDA’s clearance of mifepristone, as asked by medical groups, the decision might prevent access to one of the most widely used abortion techniques after more than a dozen states passed limits or outright prohibitions in the previous nine months.
A separate ruling by a federal district judge in Washington, also rendered on Friday, further complicated the legal situation by prohibiting the FDA from changing the situation regarding the availability of mifepristone in 16 states and the District of Columbia.
In an effort to protect access to the medicine, those states and Washington, D.C., filed a lawsuit against the Biden administration in February over a set of limits placed on it.
Mifepristone, which was given FDA approval in 2000, is used in conjunction with misoprostol to end pregnancies up to 10 weeks gestation.
Since then, the agency has changed the regulations governing the abortion pill in a number of ways, including approving a generic version of mifepristone in 2019 and eliminating the requirement that the pills be given out in person in 2021, allowing doctors to prescribe the medication during telemedicine appointments and mailing it to patients.
Safety and Efficacy of Mifepristone for Medication Abortions
The Biden administration informed the 5th Circuit that major adverse events are uncommon when mifepristone is taken as prescribed by the FDA. The Centers for Disease Control and Prevention reported that medication abortions made up more than half of all abortions in the US in 2020.
Only 28 fatalities associated with the use of mifepristone were documented through June 2022, despite the fact that more than 5 million women have taken it. Some of these deaths were linked to “clear alternative causes” unrelated to the use of the abortion pill, according to the FDA.
The Justice Department warned that the order could affect patients, their families, and providers by overburdening healthcare systems, resulting to long waits for care in a system with inadequate resources” in addition to the harmful effects it might have on women seeking abortions.
Danco Laboratories, the company that created mifepristone and submitted the initial application for FDA approval of it in 1996, has joined the Biden administration in requesting a stay from the 5th Circuit. Danco, which solely sells Mifeprex (mifepristone), has cautioned that if Kacsmaryk’s injunction is upheld, it might not be able to carry on with business as usual.
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