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mitigation strategies” (“REMS”), which “ensure that the benefits of the drug outweigh the risks.” 21 U.S.C. § 355-1(a)(1)–(2).
B.
In 2000, FDA approved mifepristone to be marketed with the brand name Mifeprex under Subpart H (the “2000 Approval”). See 21 C.F.R. § 314.500; FDA Add. 181.[1] In the 2000 Approval, FDA concluded that pregnancy is a “life-threatening illness,” triggering an accelerated approval of mifepristone under Subpart H. FDA Add. 186. FDA also concluded that a variety of post-approval restrictions on Mifeprex were required “to assure safe use.” 21 C.F.R. § 314.520. As noted in the previous section, today we call such post-approval restrictions “REMS.” The 2000 Approval imposed several REMS, including: (1) limiting the drug to pregnant women and girls for use through 49 days gestation; (2) requiring three 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; (3) requiring the supervision of a qualified physician; and (4) requiring the reporting of all adverse events from the drugs. FDA Add. 181–91. FDA granted Danco Laboratories, LLC, an exclusive license to manufacture, market, and distribute Mifeprex in the United States. FDA Add. 109.
In 2002, two of the plaintiff associations in this case filed a citizen petition challenging the 2000 Approval (the “2002 Citizen Petition”). See 21 C.F.R. § 10.25(a); PI App. 280–375. Roughly fourteen years later, FDA denied the 2002 Citizen Petition (the “2016 Petition Denial”). FDA Add.
- ↑ Citations to the addendum to FDA’s emergency motion for a stay pending appeal are denoted “FDA Add.” Citations to the appendix to plaintiffs’ motion for a preliminary injunction are denoted “PI App.”
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