The Department of Justice asked a federal appeals court on Monday to order that the abortion pill mifepristone remains on the market pending further litigation, days after Judge Matthew Kacsmaryk suspended FDA approval of the drug.
The DOJ wants the short-term administrative stay issued by Kacsmaryk to be extended and it also asked for a long-term stay pending appeal. The drug, which is part of a regimen that is the most common method of procuring an abortion, is due to become unavailable in most of the country seven days after Kacsmaryk’s ruling.
Also on Friday, a judge in Washington state issued a competing ruling that the FDA must maintain the drug’s availability in 17 Democratic-led states and the District of Columbia. The dueling opinions make it likely that higher courts will weigh in in an expedited fashion.
The Biden administration is challenging the Texas judge’s ruling on both standing as well as the merits.
“The merits of plaintiffs’ claims are not properly before any court,” the DOJ filing read. “The court also erred by holding that plaintiffs’ claims are timely.”
“FDA’s approval of mifepristone and subsequent modifications of the REMS [risk evaluation and mitigation strategy] were wholly reasonable,” the filing continued, adding that mifepristone is safe and all the available evidence conclusively demonstrates that.
The administration thus counters the plaintiffs’s arguments that the FDA never had the authority to approve the two-pill chemical-abortion regimen, that it failed to properly study the safety of the regimen, and for almost two decades stonewalled the doctors who were attempting to challenge the approval of the regimen, according to the lawsuit.
Kacsmaryk had sided with the Alliance Defending Freedom, who was arguing on behalf of the Alliance for Hippocratic Medicine, an organization of pro-life medical groups, as well as four pro-life doctors.
“The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions,” he wrote.
For the DOJ, Kacsmaryk’s order “upended the status quo with its abrupt and sweeping nationwide order. If allowed to take effect, that order will irreparably harm patients, healthcare systems, and businesses.”
Additionally, the DOJ adds, “plaintiffs have not shown that a stay would ‘substantially injure’ their interests.”
“Those defects foreclose plaintiffs’ claims, and the court flouted fundamental principles of Article III and administrative law in holding otherwise. Indeed, no precedent, from any court, endorses plaintiffs’ standing, timeliness, or merits theories,” the filing read.
If the Justice Department does not get a stay from the Fifth Circuit, it is expected to appeal to the Supreme Court.