Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 2 of 67 PageID 4424
Plaintiffs are doctors and national medical associations that provide healthcare for pregnant and post-abortive women and girls. Plaintiffs sued Defendants to challenge multiple administrative actions culminating in the 2000 Approval of the chemical abortion regimen for mifepristone. ECF No. 1 at 2. 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. ECF No. 7 at 7–8.[1] Because mifepristone alone will not always complete the abortion, 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. Id. at 8.
In 1996, the Population Council[2] filed a new drug application (“NDA”) with FDA for mifepristone. ECF No. 1 at 35. Shortly thereafter, FDA reset the NDA from “standard” to “priority review.” Id. In February 2000, FDA wrote a letter to the Population Council stating that “adequate information ha[d] not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.” ECF No. 1-24 at 6 (emphasis added). FDA also noted the “restrictions on distribution will need to be amended.” Id.
- ↑ Jurists often use the word “fetus” to inaccurately identify unborn humans in unscientific ways. The word “fetus” refers to a specific gestational stage of development, as opposed to the zygote, blastocyst, or embryo stages. See Robert P. George & Christopher Tollefsen, Embryo 27–56 (2008) (explaining the gestational stages of an unborn human). Because other jurists use the terms “unborn human” or “unborn child” interchangeably, and because both terms are inclusive of the multiple gestational stages relevant to the FDA Approval, 2016 Changes, and 2021 Changes, this Court uses “unborn human” or “unborn child” terminology throughout this Order, as appropriate.
- ↑ The Population Council was founded by John D. Rockefeller in 1952 after he convened a conference with “population activists” such as Planned Parenthood’s director and several well-known eugenicists. Matthew Connelly, Fatal Misconception: The Struggle to Control World Population 156 (2008). The conference attendees discussed “the problem of ‘quality.’” John D. Rockefeller, On the Origins of the Population Council, 3 Population and Dev. Rev. 493, 496 (1977). They 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.” Id.
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