Justice Department asks appeals court to keep abortion pill mifepristone on market as litigation plays out

The U.S. Justice Department on Monday asked a federal appeals court to keep the abortion pill mifepristone on the U.S. market as litigation plays out, 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 from taking effect. The U.S. government’s lawyers said “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.

Kacsmaryk of the U.S. Northern District of Texas said Friday that his decision to suspend the FDA approval of mifepristone would not go into effect for seven days so mifepristone distributor Danco Laboratories and the Biden administration had time to appeal.

“The Court should immediately extend the administrative stay and then stay the district court’s order pending appeal,” the Justice Department lawyers told the 5th Circuit.

Danco will likely ask the Supreme Court to intervene if the 5th Circuit does not grant the request to halt Kacsmaryk’s decision from taking effect, the company’s attorney Jessica Ellsworth said.

“I anticipate that if the Fifth Circuit does not grant a stay or at least an administrative stay, which is sort of a short term stay so it has time to consider the stay request in an orderly fashion, either Danco and or the United States will ask the U.S. Supreme Court for a stay,” Ellsworth said during a call with reporters on Monday.

When asked whether Danco will stop distributing mifepristone if Kacsmaryk’s decision takes effect this Friday, 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 ruling 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.