The decision by U.S. District Court Judge Matthew Kacsmaryk in the Northern District of Texas to issue a national injunction in the case brought by the Alliance for Hippocratic Medicine against the Food and Drug Administration (FDA) is wise and will save lives.
“Virginia Society for Human Life (VSHL) commends this action because the abortion drug not only ends the life of an unborn child, but it also places the mother of that child in harm’s way.”, said Olivia Gans Turner, president of VSHL. “ This drug has been responsible for dreadful complications to the health and well being of women ever since it was rushed through the approval process decades ago.”
The decision will place a national injunction on the use of mifepristone in chemical abortions. Judge Kacsmaryk has stayed his ruling by a week to allow the Department of Justice to appeal.
In the lawsuit, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), the plaintiffs argued that the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses.
In his decision, Judge Kacsmaryk noted the following:
· Over twenty years ago, the United States Food and Drug Administration (“FDA”) approved chemical abortion (“2000 Approval”). The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.” (pg. 1)
· Most readers would not define pregnancy to be a serious or life-threatening illness. Even FDA does not earnestly defend that position. True, complications can arise during pregnancy, and said complications can be serious or life-threatening. But that does not make pregnancy itself an illness. (pg. 44)
· One study revealed the overall incidence of adverse events is “fourfold higher” in chemical abortions when compared to surgical abortions. Women who underwent chemical abortions also experienced far higher rates of hemorrhaging, incomplete abortion, and unplanned surgical evacuation. (pg. 45)
· Contrary to popular belief and talking points, the evidence shows chemical abortion is not “as easy as taking Advil.” Compelling evidence suggests the statistics provided by FDA on the adverse effects of chemical abortion understate the negative impact the chemical abortion regimen has on women and girls. When women seek emergency care after receiving the chemical abortion pills, the abortionist that prescribed the drugs is usually not the provider to manage the mother’s complications. Consequently, the treating physician may not know the adverse event is due to mifepristone. Studies support this conclusion by finding over sixty percent of women and girls’ emergency room visits after chemical abortions are miscoded as “miscarriages” rather than adverse effects to mifepristone. Simply put, FDA’s data are incomplete and potentially misleading, as are the statistics touted by mifepristone advocates. (pg. 47)
· The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion — which was the “whole idea of mifepristone.” (pg. 57)
“The decision sheds light on a reality long hidden by the abortion industry and the Biden administration in the push to advance their radical agenda of unlimited abortion, whatever the cost to women and children. By siding with that agenda the FDA has not shown its own responsibility to the public of seeking safety first.”, said Gans Turner.
The FDA recently weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies.
Mifepristone is used in combination with misoprostol, a prostaglandin, to cause an abortion. Mifepristone blocks progesterone, leading to the death of the unborn baby, while the second drug, misoprostol, causes powerful, painful uterine contractions to expel the dead or dying baby.
“Promoters of these pills like to trumpet high safety rates, but neglect to mention how that with hundreds of thousands of women taking these pills, even a couple of percentage points of women hemorrhaging, dealing with infections, and ectopic pregnancy, represents thousands of women desperately seeking treatment, which may or may not be nearby,” said Dr. Randall K. O’Bannon, Ph.D., director of Education and Research for National Right to Life.
On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex).
Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone) can be accessed here.