The U.S. government on Monday appealed a Texas judge’s decision to suspend the Food and Drug Administration’s 23-year-old approval of a key abortion drug, saying the ruling endangered women’s health by blocking access to a pill long deemed safe.
In a filing with the 5th U.S. Circuit Court of Appeals, the Department of Justice called Judge Matthew Kacsmaryk’s decision on the drug mifepristone “especially unwarranted” because it would undermine the FDA’s scientific judgment and harm women for whom the drug is medically necessary.
The Justice Department also said the anti-abortion groups that sought to overturn the FDA’s approval had no right to sue in the first place, saying they could not show they were harmed and had left the approval unchallenged for years.
Kacsmaryk’s decision “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,” the department said.
Lawyers for the anti-abortion groups did not immediately respond to requests for comment.
Kacsmaryk, a district judge appointed by former Republican President Donald Trump, had ruled on Friday that the FDA exceeded its authority by ignoring mifepristone’s risks and relying on “plainly unsound reasoning” when approving it.
The judge, who works in Amarillo, Texas, stayed his ruling for seven days to allow the Biden administration time to appeal.
In Monday’s filing, the Justice Department asked that Kacsmaryk’s decision by stayed by April 13, and that a stay remain in place until all appeals, including if necessary to the Supreme Court, are resolved.
WHITE HOUSE DEFENDS FDA
Mifepristone is part of a two-drug regimen, also including misoprostol, for medication abortions in the first 10 weeks of pregnancy. The drugs account for more than half of all U.S. abortions.
Kacsmaryk ruled just 18 minutes before a federal judge in Washington state issued a contradictory ruling that directed the FDA to keep the drug available in 17 states.
In a Monday filing in that case, the Justice Department asked the judge there to clarify what should happen if Kacsmaryk’s order took effect.
The conflicting rulings could foreshadow a resolution by the Supreme Court, which last June overturned the 1973 Roe v. Wade decision, eliminating a constitutional right to abortion.
The Supreme Court has a 6-3 conservative majority. The New Orleans-based 5th Circuit also has a conservative reputation, with three-quarters of its active judges appointed by Republican presidents.
“This administration stands by the FDA and is prepared for this legal fight, and we will continue our work to protect reproductive rights,” White House spokesperson Karine Jean-Pierre said.
JUDGE CRITICIZED ROE
Monday’s appeal came in a case brought by anti-abortion groups led by the Alliance for Hippocratic Medicine, which was formed last August.
They accused the FDA of failing to consider during its approval process for mifepristone the drug’s safety when used by girls under age 18.
The plaintiffs sought a sympathetic court by suing in Amarillo, where Kacsmaryk is the only federal district judge.
Kacsmaryk had written critically about Roe v. Wade, and the former Christian legal activist’s courtroom is a popular destination for conservatives challenging Biden policies.
Twelve U.S. states ban abortion, while 14 others ban it at some point after six to 22 weeks of pregnancy, according to the nonprofit Guttmacher Institute, which supports abortion rights.
Some abortion providers have said they would consider a less-effective misoprostol-only regimen if mifepristone were withdrawn.
Mifepristone is available under the brand name Mifeprex and as a generic. Danco Laboratories LLC, which makes Mifeprex, is also appealing Kacsmaryk’s decision.
The case is Alliance for Hippocratic Medicine et al v FDA et al, 5th U.S. Circuit Court of Appeals, No. 23-10362.
