US asks appeals court to keep mifepristone on the market


Boxes of mifepristone, the first pill given during medical abortion, are prepared for patients at the Women’s Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023.

Evelyn Hockstein | Reuters

The US Department of Justice on Monday asked a federal appeals court to keep the abortion pill mifepristone on the US market while litigation unfolds, and said it may ask the Supreme Court to intervene in the case, days after a federal judge suspended the Food and Drug Administration’s nationwide approval of the drug.

The DOJ has asked the U.S. Court of Appeals for the 5th Circuit to block U.S. Judge Matthew Kacsmaryk’s groundbreaking decision by noon Thursday “to allow the government to seek relief from the Supreme Court if necessary.” Kacsmaryk’s suspension of mifepristone’s FDA approval is expected to take effect at 12:00 p.m. Saturday CT.

Lawyers for the Biden administration said in a 5th Circuit filing that “there is no basis for extraordinary nationwide relief that would upset a decades-old status quo.”

“If allowed to take effect, this order will cause irreparable harm to patients, healthcare systems and businesses,” Justice Department lawyers wrote in a court filing.

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

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

When asked if Danco would stop distributing mifepristone if Kacsmaryk’s decision takes effect this Saturday, Ellsworth said the company would consult with the FDA on how to proceed.

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

Used in combination with another drug, misoprostol, mifepristone is the most common method in the United States to terminate a pregnancy, accounting for about half of all abortions.

In a separate ruling on Friday, another federal judge ordered the FDA to keep mifepristone on the market in the 17 states and DCs that filed lawsuits to protect access to the drug. The ruling came from Judge Thomas Owen Rice of the U.S. District Court for the Eastern District of Washington.

Democratic lawmakers such as Sen. Ron Wyden of Oregon have dismissed Kacsmaryk’s decision as having no legal basis and are calling on the FDA to simply ignore it.

“There is no way this decision has any legal basis,” Wyden said in a statement last Friday. “Rather, it is rooted in the dangerous and undemocratic takeover of our country’s institutions by conservatives. Regardless of what happens in seven days, I believe the Food and Drug Administration has the power to ignore this decision, c That’s why I’m calling on President Biden and the FDA again to do just that.”

US Health Secretary Xavier Becerra said he would not speculate when asked by CNN whether he would order the FDA to ignore Kacsmaryk’s decision if his ruling stands.

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

Clarification: Judge Matthew Kacsmaryk’s suspension of the FDA approval of mifepristone will take effect Saturday at 12:00 p.m. An earlier version misstated the deadline.

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