By Corinne Murdock |
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.