Case: 23-10362 Document: 543-1 Page: 57 Date Filed: 08/16/2023
health risks to certain women, including those who use the drug to manage miscarriage. Br. of American College of Obstetricians and Gynecologists et al. at 21–26; Br. of Physicians for Reproductive Health at 18–27; Br. of Over 200 Reproductive Health, Rights, and Justice Organizations at 14–25; Br. of Doctors for America et al. at 14–23; Br. of Advocates for Survivors of Intimate Partner Violence at 18–26. Other amici argue that “disrupting access to mifepristone” would burden state and local health-care systems. Br. of New York et al. at 4; see also Br. of Local Governments at 24–26; Br. of the City of New York et al. at 8–31; Br. of Medical Students for Choice at 3–22. And still other amici say that staying FDA’s approval of mifepristone would destabilize the pharmaceutical industry, especially research-and-development sections. Br. of Pharmaceutical Companies, Executives, and Investors at 3–4; Br. of Pharmaceutical Research and Manufacturers of America et al. at 22–26; Br. of Patient and Provider Advocacy Organizations at 9–20.
These concerns are not insignificant. But they apply primarily (if not wholly) to the challenge to the 2000 Approval—a claim that we have concluded is not likely to succeed. All. for Hippocratic Med., 2023 WL 2913725, at *20 (“[T]hese concerns center on the district court’s removal of mifepristone from the market. [Defendants] make no arguments as to why the 2016 Major REMS Changes, the 2019 Generic Approval, or the 2021 and 2023 Mail Order Decisions are similarly critical to the public….”). Insofar as these concerns translate to the 2016 Amendments and 2021 Non-Enforcement Decision, they are lessened by the fact that mifepristone would remain available under the 2011 REMS, as would options for surgical abortion.
And of course, the public interest is disserved by a drug that does not afford adequate protections to its users. See Deerfield Med. Ctr. v. City of Deerfield Beach, 661 F.2d 328, 338 (5th Cir. 1981); Hill Dermaceuticals, Inc. v. FDA, 524 F. Supp. 2d 5, 12 (D.D.C. 2007) (“[T]he public interest weighs strongly in favor of preventing unsafe drugs from entering the market.”). To
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