Attorney General Kris Mayes has issued another challenge to keep accessibility of the controversial abortion drug mifepristone.
In a press release issued Tuesday, Mayes announced that she’d joined an amicus brief against the U.S. District Court for the Northern District of Texas ruling blocking the Food and Drug Administration (FDA) approval of mifepristone. Mayes accused Texas federal judge Matthew Kacsmaryk of being an “extremist” opposing medical consensus.
“We cannot allow anti-abortion activists and an extremist judge to undo over two decades of medical consensus. Mifepristone is safe and effective and has been used by millions of Americans over the past two decades,” said Mayes.
The efficacy and safety of mifepristone remains dubious. In the ruling challenged by Mayes, Alliance for Hippocratic Medicine v. FDA, Kacsmaryk noted the hundreds of known cases of infections and deaths arising from the drug’s usage. Kacsmaryk cited a 2006 hearing and report by the U.S. House Subcommittee on Criminal Justice, Drug Policy, and Human Resources, which noted at least 8 women’s deaths, 9 life-threatening illnesses, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection; overall, over 950 adverse event cases from the drug out of 575,000 prescriptions.
Kacsmaryk also noted that the FDA took nearly 14 years to reject a petition from multiple medical professional coalitions challenging their approval of the drug. The judge further noted that, on the same day of their rejection of the petition, the FDA expanded allowed usage for the abortion drug, changed the dosage, reduced the number of required in-person office visits, allowed non-doctors to prescribe and administer the drug, and eliminated the requirement for prescribers to report non-fatal adverse events from the drug.
In the ruling, Kacsmaryk shared that there are likely far more than the known 4,200 adverse events from chemical abortion drugs due to the FDA’s rule change eliminating non-fatal adverse reporting requirements and emergency rooms miscoding over 60 percent of women’s emergency room visits for adverse abortion drug reactions as miscarriages.
What’s more, Kacsmaryk rejected the main justification for the FDA’s approval of the abortion drug: reclassifying pregnancy as a “serious or life-threatening illness” and therefore justifying mifepristone as a “meaningful therapeutic benefit.”
“Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating life,” stated Kacsmaryk. “Nothing in the [FDA] Final Rule supports the interpretation that pregnancy is a serious or life-threatening illness.”
Kacsmaryk also pointed out that the FDA had neglected to apply its logic to expedited treatments for other, less politicized ailments.
“[C]ategorizing complications or negative psychological experiences arising from pregnancy as ‘illnesses’ is materially different than classifying pregnancy itself as a serious or life-threatening illness,” stated Kascmaryk. “Tellingly, [the] FDA never explains how or why a ‘condition’ would not qualify as a ‘serious or life-threatening illness.’ Suppose that a woman experiences depression because of lower back pain that inhibits her mobility. Under FDA’s reading, a new drug used to treat lower back pain — which can cause depression, just like unplanned pregnancy — could obtain accelerated approval [per the FDA’s rationale].”
The FDA approval took place during the Clinton administration. Similar to Kacsmaryk, the Governmental Accountability Office (GAO) noted in 2008 that medical professionals critical of the abortion drug’s approval questioned the reclassification of the abortion drug as warranted.
“Critics have argued that unwanted pregnancy should not be considered a serious or life-threatening illness.”
The Texas federal court ruling doesn’t impact Arizona at present; it may later on, based on pending future rulings in higher courts.
SCOTUS agreed to an application for a stay by the FDA of the Texas district court ruling, filed early last month. SCOTUS issued the stay late last month, allowing mifepristone to be made widely available while the appeals process plays out in the U.S. District Court of Appeals for the Fifth Circuit.
Joining Mayes in the amicus brief are the attorneys general of California, Colorado, Connecticut, Delaware, Hawai’i, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, Wisconsin, and the District of Columbia.
Arizona has been one of the nation’s most-ardent pro-life states, but its new Democrat Attorney General is seeking to quickly reverse that standing as she reacts to recent cases in the federal court system.
Last Friday, United States District Judge Matthew J. Kacsmaryk, who was appointed by former President Donald Trump, issued an order in Alliance for Hippocratic Medicine, et al. v U.S. Food and Drug Administration, granting a motion to stay “the effective date of the Food and Drug Administration’s (FDA) September 28, 2000 Approval of mifepristone and all subsequent challenged actions related to that approval – i.e., the 2016 Changes, the 2019 Generic Approval, and the 2021 Actions.”
Yet the same day, United States District Judge Thomas O. Rice, who was appointed by former President Barack Obama, issued an order in State of Washington, et al. v. U.S. Food and Drug Administration, et al., preliminarily enjoining the FDA and other defendants from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. 355-1 in Plaintiff States.”
The plaintiffs in Judge Rice’s order were Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, and the District of Columbia.
Judge Kacsmaryk stayed his own order for seven days “to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.” Judge Rice’s order went into effect immediately for the plaintiff states.
Arizona Attorney General Kris Mayes previously joined the Washington case in February, stating that the lawsuit “asserts that the FDA exceeded its authority by continuing its unnecessary and extremely burdensome restrictions on mifepristone,” and it “asks the court to find the FDA’s REMS (Risk Evaluation & Mitigation Strategies) restrictions unlawful and to bar the federal agency from enforcing or applying them to mifepristone.”
After Friday’s two judicial orders, Mayes assured her fellow Arizonans “that legal access to the drug (mifepristone) remains available for providers and patients in this state.” She promised that her office would join other states in filing an amicus brief to oppose Judge Kacsmaryk’s ruling, which came Monday. The court filing from several attorneys general across the country urged the U.S. Court of Appeals for the Fifth Circuit “to stay pending appeal the district court’s ruling.” Mayes said that “Judge Kacsmaryk’s outrageous and appalling ruling, if allowed to stand, would upend decades of scientific research and established legal principles.”
A three-judge panel quickly considered the appeal and decided that “the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.” However, the judges noted that the plaintiffs’ arguments brought before the district court in “2016 and subsequent years” were timely. The FDA’s changes from 2016-on were as follows: “increased gestational age to 70 days (from 50 days); reduced required in-person office visits to one (from three), allowed non-doctors to prescribe and administer mifepristone; and eliminated reporting of non-fatal adverse events.” In 2021, the FDA also announced “’enforcement discretion’ to allow mifepristone to be dispensed through the mail during COVID-19.”
After the decision from the Appeals Court panel, Kristen Waggoner, the CEO and President for Alliance Defending Freedom, tweeted, “Last night’s Fifth Circuit decision is a step forward for the rule of law. Critical safeguards removed by the @US_FDA will be restored and abortion by mail will end. The FDA put politics over science when it unlawfully approved dangerous chemical abortion drugs. It has evaded legal responsibility for years and has jeopardized the health of women and girls. While there is still work to do to hold the FDA accountable for its lawlessness, girls and women are safer today.”
On Thursday, Attorney General Mayes “provided a summary of the legal status of mifepristone in Arizona” – as it stood at the moment. Mayes admitted that “this is a fast-moving situation, and we are likely to see further court orders in the coming days and weeks.” She vowed to “use every tool at our disposal to fight back against rulings from extremist judges seeking to interfere with the rights of individuals to make their own personal medical decisions.” Her release broadcasted that “under Arizona law, patients in other states who need reproductive care can still travel to Arizona to receive care here.”
The case is expected to be expedited to the U.S. Supreme Court based on the conflicting rulings from the District Courts in Texas and Washington, and the updated decision from the U.S. Court of Appeals for the Fifth Circuit.
Daniel Stefanski is a reporter for AZ Free News. You can send him news tips using this link.