Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 51 of 67 PageID 4473
- a. The 2000 Approval
To begin, FDA “entirely failed to consider an important aspect of the problem” by omitting any evaluation of the psychological effects of the drug or an evaluation of the long-term medical consequences of the drug. State Farm, 463 U.S. at 43; ECF No. 84 at 12. Considering the intense psychological trauma and post-traumatic stress women often experience from chemical abortion, this failure should not be overlooked or understated. Nor was the drug tested for under-18 girls undergoing reproductive development.[1] But that is not all. Clinical trial protocols in the United States for the 2000 Approval required a transvaginal ultrasound for each patient to accurately date pregnancies and identify ectopic pregnancies. ECF No. 1-28 at 19. But FDA ultimately concluded that “a provider can accurately make such a determination by performing a pelvic examination and obtaining a careful history.” Id. Thus, FDA determined it was inappropriate “to mandate how providers clinically assess women for duration of pregnancy and for ectopic pregnancy.” ECF No. 1-28 at 19. FDA believed “it is reasonable to expect that the women’s providers would not have prescribed Mifeprex if a pelvic ultrasound examination had clearly identified an ectopic pregnancy.” Id. at 20.
FDA thus assumes physicians will ascertain gestational age. But put another way, there is simply no requirement that any procedure is done to rule out an ectopic pregnancy — which is a serious and life-threatening situation. This is arbitrary and capricious. The mere fact that other clinical methods can be used to date pregnancies does not support the view that it should be the
- ↑ In 1998, FDA issued the “Pediatric Rule,” which “mandated that drug manufacturers evaluate the safety and effectiveness of their products on pediatric patients, absent an applicable exception.” Ass’n of Am. Physicians & Surgeons, Inc. v. U.S. Food & Drug Admin., 391 F. Supp. 2d 171, 173–74 (D.D.C. 2005). Two years after approving mifepristone, FDA was enjoined from enforcing the Pediatric Rule because it lacked statutory authority in issuing the rule. See Ass’n of Am. Physicians & Surgeons v. FDA, 226 F. Supp. 2d 204, 222 (D.D.C. 2002). In response, Congress enacted the Pediatric Research Equity Act of 2003 to codify the Pediatric Rule. See 21 U.S.C. § 355c. In the 2000 Approval, FDA clarified that the Mifeprex NDA was covered by the Pediatric Rule. See ECF No. 1-26 at 4. However, FDA fully waived the rule’s requirements without explanation. ECF No. 1-28 at 30.
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