The U.S. Department of Justice on Monday asked a federal appeals court to keep the abortion pill mifepristone on the U.S. market as litigation plays out, and indicated that it may ask the Supreme Court to intervene in the case, days after a federal judge suspended the Food and Drug Administration’s approval of the medication nationwide.
The DOJ asked the U.S. 5th Circuit Court of Appeals to block U.S. Judge Matthew Kacsmaryk’s unprecedented decision by noon Thursday “to enable the government to seek relief in the Supreme Court if necessary.” Kacsmaryk’s suspension of the FDA’s approval of mifepristone is set to take effect 12 a.m. Saturday CT.
The Biden administration’s lawyers said in a filing to the 5th Circuit that “there is no basis for extraordinary nationwide relief that would upend a decades-long status quo.”
“If allowed to take effect, that order will irreparably harm patients, healthcare systems, and businesses,” the 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 careful regulatory process that has served the public for decades.”
“If this Court is inclined to deny the emergency or administrative stay, Danco also requests an administrative stay of at least fourteen days to allow Danco the opportunity to seek emergency relief from the Supreme Court,” the company’s attorney Jessica Ellsworth wrote in a court filing.
When asked whether Danco will stop distributing mifepristone if Kacsmaryk’s decision takes effect this Saturday, Ellsworth said the company will consult with the FDA about how to proceed.
“I think there will be some difficult questions that Danco needs to address and some conversations that it will need to have with FDA around what happens next,” Ellsworth said.
Used in combination with another drug misoprostol, mifepristone is the most common method in the U.S. to terminate a pregnancy, 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 D.C. that sued to protect access to the medication. 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 a basis in law,” Wyden said in a statement last Friday. “It is instead rooted in conservatives’ dangerous and undemocratic takeover of our country’s institutions. No matter what happens in seven days, I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that.”
U.S. Health Secretary Xavier Becerra said he would not engage in speculation when asked by CNN whether he would direct 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’s mifepristone approval will go into effect 12 a.m. Saturday CT. An earlier version misstated the deadline.
Read the full article here
