DOJ Files Appeal After Federal Judge Halts FDA Abortion Pill Approval

President Joe Biden’s Department of Justice (DOJ) officially filed an appeal on Monday, following a ruling out of Texas on Friday halting the U.S. Food and Drug Administration’s (FDA) 2000 approval of mifepristone, the first pill used in a two-drug medication abortion regimen.

The DOJ filed its appeal in the United States Court of Appeals for the Fifth Circuit, which is widely considered the most conservative appeals court in the country. The agency called the order out of Texas “extraordinary and unprecedented” and asked the court to stay the decision pending appeal.

“The court’s sweeping nationwide relief was especially unwarranted given the balance of harms: If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” the DOJ alleged in its appeal. “This harm would be felt throughout the country, given that mifepristone has lawful uses in every State. The order would undermine healthcare systems and the reliance interests of businesses and medical providers.”

The DOJ further alleged that plaintiffs’ claims are “manifestly untimely,” and that they lack standing to challenge the FDA’s approval of the abortion pill and have “provided no basis for second guessing the FDA’s scientific judgment.” 

The Alliance Defending Freedom (ADF) filed the lawsuit in November of 2022 against the FDA on behalf of four national medical associations and several doctors, alleging that the agency “chose politics over science and approved chemical abortion drugs for use in the United States.” The lawsuit pointed to six discrete agency actions since the legalization of mifepristone and misoprostol in 2000, and asked the court to hold the agency’s actions unlawful. The ADF filed the lawsuit in the U.S. District Court for the Northern District of Texas, and called the lawsuit the first of its kind.

Part of the ADF’s argument was that the “only way” the agency could have approved chemical abortion drugs “was to use its accelerated drug approval authority, necessitating that FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments.” 

“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs,” the complaint states. 

In a 67-page opinion, Trump-appointed U.S. District Judge Matthew Kacsmaryk wrote that the FDA unlawfully approved mifepristone and put his decision on hold for seven days to allow the “federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.”

“Chemical abortion is only the status quo insofar as Defendants’ unlawful actions and their delay in responding to Plaintiffs’ petitions have made it so. The fact that injunctive relief could upset this ‘status quo’ is therefore an insufficient basis to deny injunctive relief,” Kacsmaryk wrote.

Kacsmaryk wrote in his decision that at most, the FDA could have lawfully approved mifepristone “for cases where a pregnant woman’s life or health is in danger,” but “even a limited approval of this sort would still not render pregnancy an ‘illness.”‘

“And surgical abortion — a statistically far safer procedure — would still be available to her. But in any case, that is not what FDA did. Instead, FDA manipulated and misconstrued the text…to greenlight elective chemical abortions on a wide scale. Therefore, Plaintiffs have a substantial likelihood of prevailing on their claim that Defendants violated [the law],” he continued. 

The judge rebuffed the FDA’s argument that approval of the abortion pill should remain because unaborted children of the women “who seek but are unable to obtain an abortion” are “expected to do worse in school,” “to have more behavioral and social issues, and ultimately to attain lower levels of completed education,” and to have “lower earnings as adults, poorer health, and an increased likelihood of criminal involvement.” 

“But using abortion to promote eugenic goals is morally and prudentially debatable,” he wrote. “Though eugenics were once fashionable in the Commanding Heights and High Court, they hold less purchase after the conflict, carnage, and casualties of the last century revealed the bloody consequences of Social Darwinism practiced by would-be Übermenschen.” 

Kacsmaryk added that the “FDA stonewalled judicial review — until now,” and said the agency had ignored petitions against its approval of mifepristone for 16 years. 

Less than an hour after Kacsmaryk’s ruling, a federal judge out of Washington State issued a contradictory decision ordering the FDA to make no changes to the availability of mifepristone.

“This is an important victory for those who seek to save unborn babies,” Breitbart News senior legal contributor Ken Klukowski said in reaction to the decision from Texas. “The fact that multiple federal courts are going in opposite directions could quickly lead to what is called a circuit split at the appeals court level, which would likely send this issue to the Supreme Court within a year.”

The ADF issued a statement on Friday night calling the decision a “significant victory.”

“By illegally approving dangerous chemical abortion drugs, the FDA put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions,” Alliance Defending Freedom Senior Counsel Erik Baptist said. 

He continued: 

Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can pose serious and life-threatening complications to the mother, in addition to ending a baby’s life. The FDA never had the authority to approve these hazardous drugs and remove important safeguards. This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.

Attorney General Merrick Garland also issued a statement following the ruling, stating that the DOJ is “committed to protecting Americans’ access to legal reproductive care.” 

He said: 

The Justice Department strongly disagrees with the decision of the District Court for the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA and will be appealing the court’s decision and seeking a stay pending appeal. Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision. Separately, the Justice Department is reviewing the decision of the District Court for the Eastern District of Washington in Washington et al. v. FDA. The Department is committed to protecting Americans’ access to legal reproductive care.

The pro-abortion Guttmacher Institute found that mifepristone is used for more than half of all abortions in the United States. In 2020, the drug accounted for 53 percent of all abortions, up from 39 percent in 2017.

The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 23-10362 in the U.S. Court of Appeals for the Fifth Circuit.