CV NEWS FEED // A federal judge in Texas has extended the deadline for a lawsuit against the Food and Drug Administration (FDA) over its 2000 approval of the abortion drug mifepristone.
The Alliance for Hippocratic Medicine sued the FDA in November 2022, claiming the agency fast-tracked the pill’s approval. The FDA “failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women,” according to the summary.
The Guttmacher Institute, the research arm for Planned Parenthood, recently confirmed that over half of all abortions in the United States are induced using the drug.
According to an amicus brief submitted by the Charlotte Lozier Institute’s (CLI), the FDA’s “chemical abortion regulations disregard serious risks and elevate speculative benefits.” The brief also contends that the FDA ignored critical factors such as a lack of accurate abortion data, a misunderstanding of maternal mortality rates, and the “frequent miscoding of chemical abortion complications as miscarriage.”
Judge Matthew Kacsmaryk ordered Danco Laboratories, one of the companies that manufactures the abortion pill, to explain its opposition no later than February 24, 2023.
“Briefing will then be closed on the matter, absent any ‘exceptional or extraordinary circumstance,’” Kacsmaryk wrote in his directive.
According to Planned Parenthood, mifepristone is the first of two medications used in a chemical abortion. It blocks the hormone progesterone from reaching the woman’s uterus, breaking down the lining of the uterine wall and killing the child.
Mifepristone kills 75% of the children on whom it is used in early pregnancy. For those that survive, most die when the mother takes the followup drug misoprostol to complete the chemical abortion.
Sixty-seven members of Congress, led by Sen. Cindy Hyde-Smith, R-MS, and Rep. August Pfluger, R-TX, signed an amicus brief in support of the lawsuit.
“The FDA’s reckless decisions to approve and deregulate chemical abortion drugs put the profits and political agenda of the abortion industry over the law and abundant evidence that abortion drugs present harm to women, girls, and their unborn babies,” Sen. Hyde-Smith said.
Rep. Pfluger added that the Department of Justice’s recent memo to the United States Postal Services indicating it would not prosecute the illegal use of federal mail services to deliver abortion drugs is “blatantly putting politics over the safety of women.”
CatholicVote and the United States Conference of Catholic Bishops (USCCB) also lended their support to the lawmakers’ amicus brief.
Secular media outlets have reacted to the lawsuit with false claims that there is no attendant medical risk (to the mother) from mifepristone. CatholicVote Director of Governmental Affairs Tom McClusky noted that they are right to be concerned:
The death industry and the Biden administration put the whole future of abortion into a dangerous drug. The history dating to the 90s of the abortion chemicals has ignored women’s health. This court case could reverse all that and stop those who profit from death in their tracks.
A recent article published by Slate under the headline “Dobbs was Always Just the Beginning” argues that it would be “lawless” for U.S. District Court Judge Matthew Kacsmaryk to rule that the proliferation of chemical abortions is unconstitutional.
“Medication abortions are 18 times safer than childbirth, very reliable, and easy to access,” wrote authors Mark Joseph Stern and Dahilia Lithwick.
However, a 2021 paper studying the outcomes of chemical abortions using mifepristone concluded:
Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age.
Researchers also noted that “the FDA AER (Adverse Effects Report) system is inadequate and significantly underestimates the adverse events from mifepristone.”
An NPR piece claimed that “it would be unusual to pull a drug from the market after more than two decades of widespread safe and effective use.” The publicly-funded media outlet cited a CDC study that outlines the frequency, but does not address the safety of mifepristone in “medical abortions.”
Complete studies of the safety of mifepristone are difficult to compile. In 2016, the FDA stopped requiring abortionists to report the adverse effects of the abortion pill, except deaths. For this reason, noted McClusky, it is hard to know how many women have suffered hospitalizations, infection, fertility issues, or blood-loss.
“The next step for the FDA is to start requiring all adverse effects to be reported again so that doctors and researchers can actually ascertain the true effects of this drug on women,” McClusky said. “Abortion drugs should receive the same – if not greater – medical scrutiny that every other pill receives from the FDA, particularly since we know based on earlier studies that they harm women.”
Citing the FDA’s recent decision to allow mifepristone and misoprostol to be prescribed remotely and delivered by mail, the Lozier Institute brief further pointed out:
The consequences of telemedicine chemical abortion are almost too numerous to count—lack of necessary ultrasounds to confirm gestational age and rule out ectopic pregnancy, inability to confirm that a woman is not being coerced to obtain an abortion, abandonment of women to deal with the medical and psychological repercussions of abortion by herself with no follow-up, and grave harm to physicians who are expected to clean up the mess (in the ER and elsewhere) of self-managed abortion.
The FDA itself has in fact warned against the dangers of tele-abortion, as reported by CatholicVote in October 2022.
Slate this week published a follow-up piece by Christina Cauterucci warning that the lawsuit could constrict abortion access. “Since more than half the nation’s abortions are performed with medication—as opposed to in-office procedures—the outcome of the case could interrupt access to abortion across the country, even in blue states where abortion is legal,” she warned.
The article profiles abortionists who use or are planning to use misoprostol-only abortions,
“a popular choice for people managing their own abortions.”
Carafem, a mail-order abortion business, prescribes abortion pills via “video visit” in 15 states and the District of Columbia. Mothers are not required to receive any in-person evaluation prior to starting the at-home abortion regimen.
Anticipating the possibility that mifepristone will become illegal, Carafem has been promoting its misoprostol-only abortion practice. Slate reported: “Technically, taking misoprostol by itself to terminate a pregnancy is considered an off-label use, since the FDA has only approved the medication for gastric ulcers.”