How To File Federal Lawsuit – Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 1 of 67 ID 4423 ALLIANCE OF PHIPPOCRATIC MEDICINE, et al., Womantiffs, V. ALLIANCE OF PHIPPOCRATIC MEDICINE, et al., USA . DEPARTMENT OF PRODUCT ADMINISTRATION EU US Food and Drug Administration, et al., Defendants. REFERENCE 2:22-CV-223-Z MEMORANDUM OPINION AND FINAL The Court will consider Plaintiffs’ Motion for Preliminary Injunction (“Motion”) (ECF #6) filed on November 18, 2022. The Court GRANTS THE MOTION IN PART. More than two decades ago, the US Food and Drug Administration (FDA) approved chemical abortion (approved in 2000). The legality of the 2000 approval is now before this court. Why did it take twenty years to get a federal lawsuit? After all, the plaintiffs’ motion challenging the 2000 approval goes back to 2002, right? In short, the FDA has had limited litigation so far. Before the plaintiffs filed this suit, the FDA had ignored their petitions for more than sixteen years, but the law requires the agency to respond “within 180 days of receipt of the petition.” 21 C.F.R. § 10.30(e)(2)). But the FDA waited 4,971 days to consider the plaintiffs’ first request and 994 days to consider the second. See ECF Nos. 1-14, 1-28, 1-36, 1-44 (“2002 Petition”, “2019 Petition”, respectively). If the FDA had responded to the plaintiffs’ complaints within 360 days of being filed, the case would have been tried in federal court decades ago, instead the FDA dragged on and on and on for 6,000 days.
Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 2 of 67 Page 4424 The plaintiffs are doctors and national medical associations who provide medical care to pregnant women, girls and women after abortion. The plaintiffs sued the defendants to challenge several administrative actions that culminated in the 2000 approval of the chemical abortion regimen mifepristone. ECF #1 on 2. Mifepristone – also known as RU-486 or Mifeprex – is a synthetic steroid that blocks the hormone progesterone, inhibits feeding and ultimately starves the unborn child. ECF #7, at 7-8.¹ Because mifepristone alone does not always complete a miscarriage, the FDA prescribes a two-step drug regimen: mifepristone to kill the unborn child, followed by misoprostol to induce seizures and contractions to expel the unborn child from the mother’s womb.. ID. 8. In 1996, the Population Council² submitted a new drug application (“NDA”) for mifepristone to the FDA. ECF #1 at 35. Shortly thereafter, the FDA downgraded the NDA from “standard” to “priority review.” In February 2000, the FDA wrote a letter to the Public Advisory Board stating, “Insufficient data have been provided to demonstrate that the drug is safe and effective for the use proposed for marketing under the proposed conditions of distribution. ECF No. 1-24 , 6 (emphasis added). The FDA also noted that “distribution restrictions must be changed.” unscientific manner. The word “embryo” refers to a specific gestational stage of development, as opposed to the zygote, blastocyst, or embryo stages. See ROBERT P. GEORGE & CHRISTOPHER TOLLEFSEN, EMBRIO 27–56 (2008) (explaining the gestational stages of the unborn).Because other jurists use the terms “unborn person” or “unborn child” synonymously, and because both terms encompass multiple stages of pregnancy relevant to the FDA -authorization, the 2016 Amendments, and the 2021 Amendments, this Court has held that, as the case may be, “birth uses the terms “unborn person” or “unborn child.”2 Population Council John D. Founded by Rockefeller in 1952 after he had been drafted. Conference with “population activists” such as the director of Planned Parenthood and several prominent eugenicists. MATTHEW CONNELLY, THE DEADLY FALSE BET: THE STRUGGLE FOR WORLD POPULATION CONTROL 156 (2008). The conference participants discussed the “quality problem”. John D. Rockefeller, “On the Origins of the Population Council,” 3 POPULATION AND DEVELOPMENT. 493, 496 (1977). They argue that “[m]odern civilization has reduced the effects of natural selection by saving the lives of the ‘weak’ and allowing them to reproduce, resulting in a ‘downward trend’.” . . genetic quality”. ID. 2
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Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 3 of 67 PagelID 4425 A few months later, the FDA approved the chemical abortion scheme, often referred to as “accelerated approval” and originally developed under subpart H . Expediting investigational drugs for the treatment of HIV in the AIDS epidemic.³ Subpart H accelerates the approval of drugs that have been studied for their safety and effectiveness in the treatment of serious or life-threatening diseases and provides patients with significant therapeutic options. advantage over existing treatments (eg, the ability to treat patients unresponsive to or intolerant of available therapies or improved patient response compared to available therapies).” 21 C.F.R. § 314.500. The FDA then imposed post-approval restrictions “for to ensure safe use.” See 21 C.F.R. § 314.520. These restrictions are found later in subpart H of 21 U.S.C. § 355-1(a)(1)-(2). This drug is restricted to pregnant women and girls with infants who are seven weeks old or younger ECF #7 at 9. FDA also required only three (3) office visits: the first to administer mifepristone, the second to administer misoprostol, and the third to evaluate for any complications and check for fetal remains in the uterus. , abortionists should have been properly trained to use the regimen and to report any side effects of the drugs Plaintiffs from the United States Association of Obstetricians and Gynecologists (“AAPLOG”) and the Christian Medical and Dental Association petitioned the FDA in 2002, challenging the 2000 approval. ID. In 2006, the US House Subcommittee on Criminal Justice, Drug Policy, and Human Resources raised similar concerns and held a hearing to examine the FDA’s actions regarding 3 See, e.g. Jessica Holden Cloda & Shahza Somerville, The FDA’s Expedited Review Process. at Speed, 35 APPLIED CLINICAL TRIALS 17, 17-18 (2015) (“In 1992, in response to a push by AIDS advocates to make available the investigational AIDS drug azidothymidine (AZT), the FDA enacted “Subpart H.”’, commonly referred to as accelerated approval; results in expedited drug review by the FDA.) 3
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Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 4 of 67 4426 mifepristone and its drug monitoring.4 Chairman Souder then noted that mifepristone “has been associated with at least 8 deaths.” women, 9 life-threatening events, 232 hospitalizations, 116 transfusions, and 88 infections.”5 In addition, Chairman Souder noted “more than 950 adverse reactions” associated with mifepristone “from as many as 575,000 prescriptions.” In a subsequent staff report, the FDA approved mifepristone. concluded, that approval and monitoring “are substandard and require the withdrawal of this dangerous and deadly product before more women experience known and expected consequences or death.” reasonable and necessary to protect health.” “8 The FDA denied the 2002 petition on March 29, 2016, nearly fourteen years after it was filed. ECF #7 9. On the same day, the FDA approved several changes to the chemical abortion regimen, including the elimination of a post-approval safety restriction for pregnant women and girls . Ibid 10. The FDA increased the maximum gestation period from seven weeks to ten weeks. There. The FDA has also: (1) changed the dosage for chemical abortion; (2) reduced the number of required office visits from three to one; (3) allowed non- physicians to prescribe and perform chemical abortions; and (4) prescribers eliminated the reporting requirement for nonfatal chemical abortions. 4 See FDA and RU-486: Harms to Women’s Health: Hearing before the Subcommittee on Criminal Justice, Drug Policy, and Humanitarian Affairs H. Comm .On State Reform, 109th Cong. 3 (2006) (“Subcommittee Report”) 5 Transcript of House Subcommittee hearing available at https://www.govinfo.gov/content/pkg/CHRG-109hhrg31397/html/CHRG-109hhrg31397. htm. 6 Ibid. 7 Subcommittee’s report 40. 8 Ibid. 4
Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 5 of 67 ID 4427 In March 2019, plaintiffs AAPLOG and the American College of Pediatricians filed a complaint challenging the FDA’s 2019 safety restrictions60. ID. On April 11, 2019, the FDA approved GenBioPro, Inc.’s application. for a new drug application (“ANDA”) for a generic version of mifepristone (“2019 generic approval”) without requiring new peer-reviewed scientific studies or revision. ID. Two years later, on April 12, 2021, the FDA announced that it would “exercise its discretion” to allow the “dispensing of mifepristone by mail … or through a mail-order pharmacy” during the COVID pandemic, despite the nearly 150- years delay. the old Comstock Act, which prohibited the shipment of “[a]n article, instrument, substance, preparation, drug, or thing” that would cause “abortion.” Identifier. Finally, on December 16, 2021, the FDA denied most of the petitioner’s 2019 requests. 11. Notably, the FDA publicly denied the 2019 petitioner’s request to maintain personal delivery requirements, and the agency announced that it would permanently allow chemical abortions by mail. Id. After the plaintiffs filed suit, Danco Laboratories, LLC (“Danco”), the holder of the NDA for mifepristone, sued as defendant. ECF No. 19. On February 6, 2023, this court granted Danko’s motion. ECF
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