Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 3 of 67 PageID 4425
Mere months later, FDA approved the chemical abortion regimen under Subpart H, commonly known as “accelerated approval” and originally designed to expedite investigational HIV medications during the AIDS epidemic.[1] Subpart H accelerates approval of drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).” 21 C.F.R. § 314.500.
FDA then imposed post-approval restrictions “to assure safe use.” See 21 C.F.R. § 314.520. These restrictions were later adopted when Subpart H was codified as a Risk Evaluation and Mitigation Strategy (“REMS”) “to ensure that the benefits of the drug outweigh the risks.” 21 U.S.C. § 355-1(a)(1)–(2). The drugs were limited to women and girls with unborn children aged seven-weeks gestation or younger. ECF No. 7 at 9. FDA also required three (3) 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. Id. Additionally, abortionists were required to be properly trained to administer the regimen and to report all adverse events from the drugs. Id.
Plaintiffs American Association of Pro-Life Obstetricians & Gynecologists (“AAPLOG”) and Christian Medical & Dental Associations filed the 2002 Petition with FDA challenging the 2000 Approval. Id. In 2006, the U.S. House Subcommittee on Criminal Justice, Drug Policy, and Human Resources expressed the same concerns and held a hearing to investigate FDA’s handling
- ↑ See, e.g., Jessica Holden Kloda & Shahza Somerville, FDA’s Expedited Review Process: The Need for Speed, 35 Applied Clinical Trials 17, 17–18 (2015) (“In 1992, in response to a push by AIDS advocates to make the investigational anti-AIDS drug azidothymidine (AZT) accessible, the FDA enacted ‘Subpart H’ commonly referred to as accelerated approval; giving rise to expedited review of drugs by the FDA.”).
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