The Biden administration on Monday afternoon asked an appeals court to put on hold a ruling that could rescind the Food and Drug Administration’s (FDA) approval of mifepristone, one of two drugs used in medication abortions.
The Department of Justice (DOJ) asked the 5th U.S. Circuit Court of Appeals to pause U.S. District Court Judge Matthew Kacsmaryk’s ruling from Friday, which found the FDA violated federal standards when it first approved mifepristone 23 years ago, until the administration can bring its appeal of his decision in full.
“Rather than preserving the status quo, as preliminary relief is meant to do, the district court upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety,” DOJ wrote in court filings.
Kacsmaryk’s ruling gave the administration a weeklong window before it went into effect. The administration is asking the 5th Circuit to extend that pause, and to do so by Thursday at noon, “to enable the government to seek relief in the Supreme Court if necessary.”
The emergency motion included a searing criticism of Kacsmaryk’s decision, arguing that the challengers did not have standing to bring the suit and that their claims challenging the drug’s safety lack merit and would be unlikely to ultimately succeed.
“The district court’s extraordinary and unprecedented order should be stayed pending appeal. Plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe; their challenge to FDA actions dating back to 2000 is manifestly untimely; and they have provided no basis for second-guessing FDA’s scientific judgment. Those defects foreclose plaintiffs’ claims, and the court flouted fundamental principles of Article III and administrative law in holding otherwise,” the Justice Department wrote.
Minutes after Kacsmaryk, an appointee of former President Trump, issued his ruling, however, a separate federal judge who sits in Washington state blocked the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in 17 states and Washington, D.C., which filed a joint lawsuit contending the drug was too tightly regulated.
DOJ said on Friday it was reviewing that ruling, issued by U.S. District Judge Thomas Rice, an appointee of former President Obama.
The dueling decisions increase the likelihood the dispute ultimately reaches the Supreme Court one way or another, with far-reaching implications for access to abortion nationwide as well as the authority of the entire FDA.
—Updated at 3:03 p.m.
