“Unborn humans.” “Eugenics.” “Head, hands, and legs, with defined fingers and toes.” “Shame, regret, anxiety, depression, drug abuse, and suicidal thoughts.”
Federal Judge Matthew Kacsmaryk’s Friday decision freezing the FDA’s approval of the abortion-pill combination, mifepristone and misoprostol, included these phrases and more. And while the left is already attacking Kacsmaryk’s 67-page straight-talking opinion in Alliance for Hippocratic Medicine v. FDA by framing it as filled with anti-abortion rhetoric, the Trump appointee stuck to the facts — something Americans desperately need to hear after decades of euphemistic discussions about abortion.
After a brief introduction in which Kacsmaryk highlighted the FDA’s two decades of stonewalling that delayed a legal challenge to the 2000 approval of the abortion drugs, the court opened with the basic facts. The plaintiffs — doctors and medical associations that provide health care to pregnant and post-abortive women and girls — sued the FDA, challenging several administrative actions related to the approval of the chemical abortion drugs.
The court then explained the drugs and their functioning: “Mifepristone — also known as RU-486 or Mifeprex — is a synthetic steroid that blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death.” But “because mifepristone alone will not always complete the abortion,” the court continued, “the FDA mandates a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb.”
Calling an unborn human an “unborn human” immediately triggered abortion activists, but as Kacsmaryk explained in a footnote, such terminology is scientifically correct, whereas the lawyers and courts “often use the word ‘fetus’ to inaccurately identify unborn humans in unscientific ways.”
“The word ‘fetus,’” Kacsmaryk explained, “refers to a specific gestational stage of development, as opposed to the zygote, blastocyst, or embryo stages.” And because the FDA’s approval of the abortion drugs applies at multiple “gestational stages,” the word “fetus” would be inaccurate.
It is understandable that abortion activists want to hide the humanity of unborn humans, but that doesn’t make the science less real: It just means girls and women who have bought the “clump of cells” narrative will suffer when faced with the truth, which chemical “at home abortions” force.
“The mother seeing the aborted human ‘appears to be a difficult aspect of the medical termination process which can be distressing, bring home the reality of the event and may influence later emotional adaptation,’” the court wrote, based on the record evidence. “For example, one woman was surprised and saddened to see that her aborted baby ‘had a head, hands, and legs’ with ‘[d]efined fingers and toes.’”
Another woman alleged that “she did not receive an ultrasound or any other physical examination before receiving chemical abortion drugs from Planned Parenthood.” According to the record, “The abortionist misdated the baby’s gestational age as six weeks, resulting in the at-home delivery of a ‘lifeless, fully formed baby in the toilet,’ later determined to be around 30-36 weeks old.”
Harm to Women
Beyond exposing the reality that abortion kills an unborn human, Kacsmaryk’s opinion also refuted the “popular belief and talking points” that using the abortion pill is “as easy as taking Advil.” Here, the federal judge detailed the factual evidence. Among other things, “bleeding from a chemical abortion, unlike surgical abortion, can last up to several weeks,” and by being done at home, “without physician oversight,” it can lead “to undetected ectopic pregnancies, failure of rH factor incompatibility detection, and misdiagnosis of gestational age — all leading to severe or even fatal consequences.”
The opinion also countered the claim that side effects are rare by highlighting evidence that “over sixty percent of women and girls’ emergency room visits after chemical abortions are miscoded as ‘miscarriages’ rather than adverse effects to mifepristone.”
The evidence also shows emotional and psychological injury, Kacsmaryk stressed, with 77 percent of women who underwent a chemical abortion reporting “a negative change” after the at-home abortion, and 38 percent of women reporting issues “with anxiety, depression, drug abuse, and suicidal thoughts because of the chemical abortion.”
While the abortion industry prefers to cite its own evidence, as Kacsmaryk noted, those studies are flawed both because of the miscoding of chemical abortions as miscarriages and because the FDA stopped requiring the reporting of non-fatal adverse reactions.
The left also didn’t like Kacsmaryk exposing the eugenic beliefs of the Population Council, which had sought FDA approval for the abortion drugs. John D. Rockefeller founded the Population Council in 1952, “after he convened a conference with ‘population activists’ such as Planned Parenthood’s director and several well-known eugenicists,” the court wrote. Attendees of that conference discussed “the problem of ‘quality,’” and concluded that “[m]odern civilization had reduced the operation of natural selection by saving more ‘weak’ lives and enabling them to reproduce,” thereby resulting in “a downward trend in … genetic quality.”
Many Americans remain oblivious to the historical backdrop eugenics played to the abortion movement, and activist groups prefer they remain in the dark. The sunlight Kacsmaryk shined upon that truth infuriates them.
Judge Kacsmaryk also exposed the political pressure placed on the FDA to approve the abortion drug — something Americans are likely to appreciate more today in the aftermath of the FDA’s hasty approval of the Covid mRNA shots.
In the case of the abortion pill, the FDA took the unprecedented step of arranging a meeting between the French pharmaceutical company that owned the patent rights and the eventual drug sponsor, the Population Council. “The purpose of the FDA-organized meeting was ‘to facilitate an agreement between those parties to work together to test [mifepristone] and file a new drug application.’”
Evidence further shows the Department of Health and Human Services “initiated” another meeting to determine how the Clinton administration “might facilitate successful completion of the negotiations” between the French firm and the Population Council to ensure the group secure patent rights and eventual FDA approval.” In fact, Clinton’s HHS secretary “believed American pressure on the French firm was necessary.”
Then after the Population Council submitted a new drug application, the FDA proposed detailed restrictions to address safety concerns, including that the drug be administered by doctors “trained and authorized by law” to perform surgical abortions; trained in administering mifepristone and treating adverse events; and able to provide treatment at a medical facility that had the equipment necessary to perform surgical abortions, resuscitation procedures, and blood transfusion, within one hour’s drive. The FDA’s restrictions were leaked to the press, prompting a political firestorm.
So Much for Safety
The FDA later abandoned the above safety mandates and approved the drug for use to kill unborn humans aged seven-weeks gestation or younger. The FDA further required three “in-person office visits: the first to administer mifepristone, the second to administer misoprostol, and the third to assess any complications and ensure there were no fetal remains in the womb.” All adverse events were also required to be reported.
In 2002, the FDA removed even more of the safety restrictions, increasing the maximum gestational age from seven-weeks gestation to 10-weeks gestation, reducing the number of office visits from three to one, increasing the drug dosage, allowing non-doctors to prescribe and administer chemical abortions, and eliminating the requirement for non-fatal adverse reactions to be reported. Then in 2019, the FDA approved a generic version of the abortion pills, and on April 12, 2021, the FDA announced it would allow abortion pills to be dispensed through the mail.
“Whether FDA abandoned its proposed restrictions because of political pressure or not,” the court wrote, “one thing is clear: the lack of restrictions resulted in many deaths and many more severe or threatening adverse reactions.” But “due to FDA’s lax reporting requirements, the exact number is not ascertainable,” Kacsmaryk stressed.
But it was not on politics that Kacsmaryk based his decision to freeze the FDA’s approval of the abortion pill. Rather, in his methodical opinion, the federal judge explained that the FDA lacked the authority to accelerate approval of the drug under what is called “Subpart H” of the FDA. That subpart only allows for accelerated approval of drugs that treat “serious or life-threatening illnesses” — something pregnancy is not.
Kacsmaryk also concluded the evidence the FDA supposedly relied upon to approve the abortion drugs failed to support the conclusion that they were “safe and effective under particular conditions of use.” And finally, Kacsmaryk held the FDA’s approval of mail distribution violated the 1873 Comstock Act, which makes it illegal to use the mail to deliver any “article or thing designed, adapted, or intended for producing abortion.”
The Biden administration has already filed a notice of appeal with the Fifth Circuit Court of Appeals, and in issuing his opinion in Alliance for Hippocratic Medicine v. FDA, Kacsmaryk entered a temporary stay, which he or the court of appeals will likely make permanent pending resolution of the case. Thus, abortion pills will remain available for now.
How the Fifth Circuit and eventually the Supreme Court will rule remains to be seen, but what is clear now is the abortion-loving left is desperate to keep the truth about abortion from the public and is furious that Kacsmaryk dared to expose the reality: Abortion kills unborn humans.