US is asking the Court docket of Appeals to maintain mifepristone available on the market

Boxes of mifepristone, the first pill to be given in a medical abortion, are prepared for patients at the Women’s Reproductive Clinic of New Mexico in Santa Teresa, the United States, January 13, 2023.

Evelyn Hockstein Reuters

The U.S. Department of Justice on Monday asked a federal appeals court to keep the abortion pill mifepristone on the U.S. market during the legal battle, noting it could ask the Supreme Court to intervene in the case days after a federal judge suspended the meal had and had federal drug agency approval by the drug agency.

The DOJ asked the US Fifth Circuit Court of Circuits to block US Judge Matthew Kacsmaryk’s unprecedented decision until noon Thursday “to allow the government to seek remedy in the Supreme Court if necessary.” Kacsmaryk’s suspension of FDA approval of mifepristone is scheduled to take effect at 12:00 p.m. CT Saturday.

Attorneys for the Biden administration said in a filing in the Fifth Circuit Court that “there is no basis for an extraordinary statewide relief that would upend a decades-old status quo.”

“If this order is allowed to go into effect, it will irreparably harm patients, healthcare systems and businesses,” Justice Department attorneys wrote in a court filing.

Danco Laboratories, the distributor of mifepristone, also called on the 5th Circuit to block the effectiveness of Kacsmaryk’s decision, calling it an “unprecedented judicial assault on a diligent regulatory process that has served the public for decades.”

“If this court is inclined to deny the state of emergency or administrative stay, Danco will also request an administrative stay of at least fourteen days to allow Danco to seek emergency relief from the Supreme Court,” company attorney Jessica Ellsworth wrote. in a court record.

When asked if Danco will stop selling mifepristone if Kacsmaryk’s decision goes into effect this Saturday, Ellsworth said the company will be consulting with the FDA on how to proceed.

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“I think there will be some tough questions that Danco needs to address and some conversations that it needs to have with the FDA about what happens next,” Ellsworth said.

When combined with another drug, misoprostol, mifepristone is the most common method of terminating a pregnancy in the United States, accounting for about half of all abortions.

In a separate ruling Friday, another federal judge ordered the FDA to keep mifepristone on the market in the 17 states and DC that had sued to protect access to the drug. The verdict came from Judge Thomas Owen Rice of the US District Court for the Eastern District of Washington.

Democratic lawmakers like Oregon Sen. Ron Wyden have dismissed Kacsmaryk’s decision as expendable and are asking the FDA to simply ignore it.

“There is absolutely no legal basis for this decision,” Wyden said in a statement last Friday. “It is rooted instead in the dangerous and undemocratic takeover of our country’s institutions by conservatives. No matter what happens in seven days, I believe the Food and Drug Administration has the authority to overrule this ruling, which is why I am again calling on President Biden and the FDA to do just that.”

US Health Secretary Xavier Becerra said he would not participate in speculation when asked by CNN if he would direct the FDA to ignore Kacsmaryk’s decision if his decision stands.

Becerra said that “everything is on the table” to gain access to mifepristone.

Clarification: Judge Matthew Kacsmaryk’s suspension of mifepristone’s approval goes into effect at 12:00 pm CT Saturday. In an earlier version, the deadline was incorrectly specified.

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