The Department of Justice asked a federal appeals court on Monday to order the abortion pill mifepristone to remain 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 two-pill 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.
Kacsmaryk, who sits on the U.S. District Court for the Northern District of Texas, issued a nationwide preliminary injunction Friday. However, within hours, Judge Thomas Rice of the Eastern District of Washington 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 orders make it likely that higher courts will consider appeals in an expedited fashion.
The Biden administration is challenging the Texas judge’s ruling on both standing as well as the merits.
“Plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe,” 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 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.
Kacsmaryk had sided with the plaintiffs — namely, 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.
The FDA originally approved the use of the regimen under a section of federal code known as Subpart H, which allows for expedited approval of drugs that can be used to treat “serious or life-threatening illnesses” or that provide a “meaningful therapeutic advantage over existing treatment.”
The Alliance Defending Freedom (ADF), arguing on behalf of the plaintiffs, said the FDA had no business approving the regimen under Subpart H because pregnancy is not an illness but is rather a “normal physiological state that many females experience one or more times during their childbearing years.” ADF lawyers contended that the pills are more dangerous than surgical abortion and that they don’t provide a meaningful therapeutic benefit over surgery.
However, the Justice Department argued that Subpart H was properly invoked, saying that the “FDA found that pregnancy ‘can be a serious medical condition in some women,’ and mifepristone avoided a surgical procedure for 92% of patients.” The DOJ explained that in the FDA’s view, avoiding a surgery is a meaningful therapeutic benefit.
In any case, the DOJ argued, plaintiffs could not challenge the FDA’s 2000 approval because the statute of limitations had expired and was not reopened in 2016, when the FDA modified mifepristone’s approved conditions of use. For the DOJ, “a serious, substantive reconsideration” of mifepristone, which would restart the statute, did not occur in 2016.
The Justice Department argued that the court in Texas “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.” The DOJ also argued the “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. Danco, the maker of Mifeprex, the brand version of mifepristone, has filed a similar appeal against Kacsmaryk’s order.
In a separate filing Monday, the DOJ asked Judge Rice in Washington how the government can comply with his order preserving access to the abortion pill if Kacsmaryk’s order is allowed to go into effect. The administration pointed out that there is “significant tension” between the two rulings.