Attorneys general for 19 states filed an amicus brief on Wednesday, asking a federal appeals court to uphold a ruling out of Texas blocking the U.S. Food and Drug Administration’s (FDA) approval of mifepristone, the first drug used in a two-drug medication abortion regimen.
The attorneys general filed the brief in the United States Court of Appeals for the Fifth Circuit — which is widely considered the most conservative appeals court in the country — after the Department of Justice filed an appeal of U.S. District Judge Matthew Kacsmaryk’s order halting the FDA’s approval of the abortion pill. Alliance Defending Freedom (ADF), which filed the lawsuit in November of 2022 against the FDA on behalf of four national medical associations and several doctors, filed its opposition to an emergency stay pending appeal in the Fifth Circuit on Tuesday.
Mississippi Attorney General Lynn Fitch led the effort, stating in the brief that “rather than respect the Constitution, the Supreme Court, and the democratic process, the Biden Administration and its FDA has attacked and worked to undermine the considered judgments of the elected representatives of States.”
“The Biden Administration has, following Dobbs, doubled down on its efforts to impose on the country an elective-abortion policy that it could never achieve through the democratic process….” the brief states:
The serious nature of the FDA’s unlawful actions, and the agency’s decision to invite lawbreaking by private parties and government actors across the country, favors the relief the district court ordered….The District court’s decisive action was warranted. And this Court’s is too. This Court should deny any stay relief.
The states accuse the FDA of defying federal law, undermining the “public-interest determinations that states — not federal agencies — are entitled to make,” and harming public interest by “undermining states’ ability to protect their citizens.”
“In the actions at issue here, the FDA has sought to impose a federal mail-order abortion regime that disregards the protections for life, health, and safety adopted by numerous States’ elected representatives,” the brief alleges. “But the authority to “regulate or prohibit abortion belongs to the citizens of each State.”
“The FDA may determine only whether mifepristone is ‘safe and effective’ for its intended use, in accordance with the Federal Food, Drug, and Cosmetic Act,” the brief continues:
The agency has no authority to approve dangerous drugs in violation of federal law—much less make broad policy judgments balancing the people’s interests in ‘prenatal life at all stages of development,’ ‘maternal health and safety,’ and ‘the integrity of the medical profession.’
The ADF’s lawsuit notably points to six discrete FDA 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.”
The lawsuit then details how, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take the abortion drugs from seven weeks’ gestation to ten weeks’ gestation. Then in 2019, the FDA allegedly approved a generic version of the drug “without requiring any new clinical investigations or studies that evaluated the drug’s safety and effectiveness under the requirements” of several laws, according to the complaint.
In 2021, the FDA allowed abortionists to send mifepristone through the mail, which the ADF says was “in direct violation of federal law.” The FDA recently made permanent its rule to allow women and girls to receive a prescription for mifepristone via telemedicine.
The complaint alleges:
All of the FDA’s actions on chemical abortion drugs—the 2000 approval, the 2016 major changes, the 2019 generic drug approval, and the two 2021 actions to eliminate the in-person dispensing requirement—failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail, express company, or common carrier. Instead, the FDA’s actions permitted and sometimes even encouraged these illegal activities.
Additionally, the complaint alleges that despite major changes to the regimen throughout the decades the FDA “eliminated the requirement for prescribers to report all nonfatal serious adverse events from chemical abortion drugs.”
Kacsmaryk issued a 67-page opinion on Friday, stating that the FDA unlawfully approved mifepristone and that plaintiffs have a likelihood of success on the merits of their case. The Trump-appointed judge 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.”
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. That ruling affects only the 17 states and the District of Columbia involved in the challenge, whereas the ruling out of Texas is a nationwide order.
Attorneys General from Alabama, Arkansas, Florida, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Montana, Nebraska, Ohio, South Carolina, South Dakota, Tennessee, Texas, Utah, and Wyoming joined Fitch on the brief.
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.