Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/2

 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. 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 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.