1 Am. Coll. of Obstetricians & Gynecologists v. United States Food & Drug Admin., (No. TDC-20-1320), 2020 WL 3960625, at *2-3 (D. Md. May 27, 2020) (order granting preliminary injunction); Complaint at 13-16, Am. Coll. of Obstetricians and Gynecologists v. United States Food & Drug Admin., 2020 WL 3960625 (No. TDC-20-1320) (citations omitted).

2 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *3 (order granting preliminary injunction).

3 Id. at *5-6; Complaint, at 33-7, Am. Coll. of Obstetricians and Gynecologists v. Food & Drug Admin., 2020 WL 3960625.

4 Complaint, at 6-13, Am. Coll. of Obstetricians and Gynecologists v. Food & Drug Admin., 2020 WL 3960625.

5 Id. at *38.

6 Id. at *23-32.

7 Id. at *80.

8 Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, No. 20A34, 2020 WL 5951467, at *1 (Oct. 8, 2020) (holding Government’s application for stay of preliminary injunction in abeyance); Am. Coll. of Obstetricians & Gynecologists v. Food & Drug Admin., No. 20-1824, 2020 WL 3960625, at *1 (4th Cir. Aug. 13, 2020) (order denying Government’s motion to stay preliminary injunction).

9 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *3.

10 Id. at *3 (citing 21 U.S.C. §§ 301-399i (2018)); see 21 U.S.C. § 355-1; see also Food & Drug Admin. Act of 2007, Pub. L. No. 110-85, 121 Stat. 823, 922-43 (2007).

11 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *3.

12 Id. at *3-6.

13 Id. at *3-4.

14 Id. at *5-6 (citing 21 U.S.C. § 355-1(f)(3)(A), (C), (D)).

15 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *6.

16 Id. at *4; Complaint, \ at Am. Coll. of Obstetricians and Gynecologists., 2020 WL 3960625 (citation omitted). In both 2013 and 2016, the FDA did not consider the applicability of telemedicine when reviewing of mifepristone REMS. Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *55.

17 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *4-5.

18 Id. at *4 (citations omitted).

19 Id. at *5 (proposing modifications to mifepristone’s REMS in response to drug sponsor’s supplemental application).

20 Complaint, Am. Coll. of Obstetricians and Gynecologists, 2020 WL 3960625, at *39-40.

21 Id. at 4-5.

22 Bun Hu et al., Characteristics of SARS-COV-2 and COVID-19, Nature Revs. Microbiology (2020).

23 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *42 (citing Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, White House (Mar. 13, 2020), https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/ [https://perma.cc/RR65-6BYN]).

24 Id. at *9.

25 Id. at *9-10 (citing 42 U.S.C. § 247d(a)).

26 Id. at *9-12 (citations omitted).

27 Complaint, Am. Coll. of Obstetricians and Gynecologists, 2020 WL 3960625, at 2-3.

28 Id. at 5.

29 Id. at 39-40.

30 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *18 (citing Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 22 (2008)).

31 Id. (citing Winter, 555 U.S. at 20; Pashby v. Delia, 709 F.3d 307, 320 (4th Cir. 2013)).

32 Id. (citing U.S. CONST. art. III, § 2, cl. 1; Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992); Covenant Media of S.C., L.L.C. v. City of N. Charleston, 493 F.3d 421, 428 (4th Cir. 2007)).

33 Id. at *22.

34 Id. (quoting Powers v. Ohio, 499 U.S. 400, 411 (1991)).

35 Id. at *19-30 (noting that “the presence of one plaintiff with standing renders a claim justiciable”).

36 Id. at *32 (citing Roe v. Wade, 410 U.S. 113, 154 (1973)).

37 Id. (citing Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 U.S. 833, 877 (1992)). The undue burden standard has since been re-reaffirmed in subsequent Supreme Court cases. Id. (citing June Medical Servs. L.L.C. v. Russo, 140 S. Ct. 2103, 2119 (2020); Whole Woman’s Health v. Hellerstedt, 136 S. Ct. 2292, 2301 (2016)).

38 Id. at *32 (citing June Medical Servs, 140 S. Ct. at 2119; Whole Woman’s Health, 136 S. Ct. at 2301-15).

39 Id. at *60-62 (citing Whole Woman’s Health, 136 S. Ct. at 2309, 2320; Casey, 505 U.S. at 893; Planned Parenthood Arizona v. Humble, 753 F.3d 905, 912-13 (9th Cir. 2014)).

40 Id. at *40-41 (citing Casey, 505 U.S. at 893, 895).

41 Id. at *34-35.

42 Id. at *36. To support this interpretation of the undue burden standard, the Government cited to the Chief Justice’s concurrence in June Medical Services, which argued that a balancing test assessing both benefits and burdens was an incorrect application of Casey’s analysis. Id. (citing June Med. Servs., 140 S. Ct. at 2139 (Roberts, C.J., concurring); Casey, 505 U.S.). The District Court concluded that the plurality and concurrence in June Medical Services could both be reconciled to conclude that a “‘substantial obstacle’ based solely on consideration of burdens is sufficient to satisfy the undue burden standard, not that it is necessary.” Id. at *37 (citing June Med. Servs., 2020 WL 3492640; A.T. Massey Coal Co. v. Massanari, 305 F.3d 226, 236 (4th Cir. 2002)).

43 Id. at *36-37 (citing June Medical Servs, 140 S. Ct. at 2119; Whole Woman’s Health, 136 S. Ct. at 2301-15).

44 Id. at *40 (citing Humble, 753 F.3d at 917

45 Id. at *49-50.

46 Id.

47 Id. at *62.

48 Id. at *63.

49 Id. at *59-62.

50 Id. at *18 (citing Winter, 555 U.S. at 20).

51 Id. at *68-69 (citing Ross v. Meese, 818 F.2d 1132, 1135 (4th Cir. 1987)) (“[T]he denial of a constitutional right … constitutes irreparable harm for purposes of equitable jurisdiction.); see also id. (citing Humble, 753 F.3d at 911; Elrod v. Burns, 427 U.S. 347, 373 (1976) (plurality opinion)).

52 Id. at *69-70.

53 Id. at *71; Defendants’ Memorandum in Opposition to Plaintiffs’ Motion for Preliminary Injunction at 32, Am. Coll. of Obstetricians & Gynecologists, (No. TDC-20-1320), 2020 WL 3960625 (citing Abney v. Amgen, Inc., 443 F.3d 540, 553 (6th Cir. 2006)) (“The public has a strong interest in ensuring that the FDA rather [than] individual doctors has the power to decide what drugs meet baseline levels of safety and efficacy.”).

54 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *71.

55 Id.

56 Id. at *70-71.

57 Id. at *71-72.

58 Id. at *63-64. The standing of the Plaintiffs on the equal protection claim did not depend on third-party standing, as the prescribing providers of mifepristone were allegedly suffering differential treatment in direct violation of their “equal protection right to be free from unequal treatment.” Id. at *31 (citing Ne. Fla. Chapter of Associated Gen. Contractors of Am. v. City of Jacksonville, 508 U.S. 656, 666 (1993)). The Plaintiffs could demonstrate injury-in-fact, as potential sanctions could be imposed on providers who did not satisfy REMS requirements when dispensing mifepristone. Id. at *21-22.

59 Complaint, at 38 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625.

60 Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625, at *64-65.

61 Id. at *65-68.

62 Id. at *68.

63 Id. at *72-73 (quoting Califano v. Yamasaki, 442 U.S. 682, 702 (1979)); see also id. at *73 (quoting Richmond Tenants Org., Inc. v. Kemp, 956 F.2d 1300, 1308 (4th Cir. 1992)) (“‘It is well established … that a federal district court has wide discretion to fashion appropriate injunctive relief… [that] may extend outside the district that the court sits.’”).

64 Id. at *73.

65 Id. at *75-76 (citing Roe, 947 F.3d at 232). District Court drew direct parallels between mifepristone’s In-Person Requirements and the policies at issue in Roe to conclude that “such a categorical policy warrants categorical relief.” Id.

66 Id. at *76 (quoting Roe, 947 F.3d at 233-34).

67 Id. at *76-77.

68 Id. at *78.

69 Id at *76-77. As the Government was in charge of declaring the end of the public health emergency, the District Court extended the preliminary injunction until 30 days after the public health emergency concluded, so that there would be enough time for the Plaintiffs to for file an extension, if necessary. Id.

70 Id.

71 Application for a Stay of the Injunction Issued by the United States District Court for the District of Maryland at 3, Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, (No. 20A34), 2020 WL 5951467; Motion for Stay Pending Appeal at 2, Am. Coll. of Obstetricians & Gynecologists v. Food & Drug Admin., (No. 20-1824) 2020 WL 3960625.

72 Motion for Stay Pending Appeal, at 6-18 2020 WL 3960625.

73 Id. at 7-8.

74 Id. at 9-12 (quoting Gonzales v. Carhart, 550 U.S. 124, 163-165 (2007)).

75 Id. at 14-19.

76 Id. at 18.

77 Id. at 19 (citing Nken v. Holder, 556 U.S. 418, 435 (2009)).

78 Id. at 20-21.

79 Am. Coll. of Obstetricians & Gynecologists v. Food & Drug Admin., (No. 20-1824), 2020 WL 3960625, at *1 (4th Cir. Aug. 13, 2020).

80 Application for a Stay, at 1, Am. Coll. of Obstetricians & Gynecologists, 2020 WL 5951467.

81 Food & Drug Admin., 2020 WL 5951467 at *1.

82 Rachel K. Jones, Elizabeth Witwer & Jenna Jerman, Abortion Incidence and Service Availability in the United States, 2017, Guttmacher Inst.(Sept. 2019), https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017 [https://perma.cc/TT7L-7958] (noting that, in 2017, 39% of all abortions that were performed in the United States were early medical abortions); see also Jatlaoui, Tara et al., Abortion Surveillance – United States 2016, 68 Morbidity and Mortality Wkly. Rep 1, 8(2019)Google Scholar (noting that the use of early medical abortions increased by 113% between 2007 and 2016).

83 See Lauri Sobel et al., State Action to Limit Abortion Action During the COVID-19 Pandemic, KFF (Aug. 10, 2020), https://www.kff.org/coronavirus-covid-19/issue-brief/state-action-to-limit-abortion-access-during-the-covid-19-pandemic/ [https://perma.cc/7CNF-9LKK].

84 See Complaint, Chelius v. Wright, No. 17-cv-00493-DKW-KSC, 2017 WL 4401999, (D. Hawaii Oct. 3, 2017) (substituting Azar for Wright on April 12, 2018 upon Azar’s appointment as Secretary of the HHS). At the request of all parties involved, Chelius was granted a continuance until at least October 27, 2020, pending the outcome of ACOG v. FDA. See Chelius, 2017 WL 4401999, at *3.

85 Complaint, at 3-8, Chelius v. Wright, 2017 WL 4401999.

86 Complaint, at 33-7,Am. Coll. of Obstetricians & Gynecologists, 2020 WL 3960625.

87 Food & Drug Admin., 2020 WL 5951467, at *1.

88 Id., at *3 (Alito, J., joined by Thomas, J., dissenting); see S. Bay United Pentecostal Church v. Newsom, 140 S. Ct. 1613 (2020) (Roberts, J., concurring) (“Our Constitution principally entrusts ‘[t]he safety and the health of the people” to the politically accountable officials of the States “to guard and protect.’ Jacobson v. Massachusetts, 197 U. S. 11, 38 (1905). When those officials ‘undertake[] to act in areas fraught with medical and scientific uncertainties,’ their latitude ‘must be especially broad.’ Marshall v. United States, 414 U.S. 417, 427 (1974). Where those broad limits are not exceeded, they should not be subject to second-guessing by an ‘unelected federal judiciary,’ which lacks the background, competence, and expertise to assess public health and is not ac-countable to the people.”).

89 Food & Drug Admin., 2020 WL 5951467, at *1; Sharkey, Catherine, The Anti-Deference Pro-Preemption Paradox at the U.S. Supreme Court: The Business Community Weighs In, 67 Case W. Res. L. Rev. 805, 814 (2017).Google Scholar

90 Food & Drug Admin., 2020 WL 5951467, at *2-5 (Alito, J., joined by Thomas, J., dissenting) (“[C]hanges in the severity of the problems caused by the COVID–19 pandemic … do[] not justify the Court’s refusal to rule.”).

91 Id. at *1.

92 See State Action to Limit Abortion Action During the COVID-19 Pandemic, KFF (June 8, 2020), https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/ [https://perma.cc/DH28-NT7A].

93 Id.

94 See, e.g., Letter from Senator Ted Cruz to FDA Commissioner Stephen Hahn (Sept. 1, 2020), https://www.cruz.senate.gov/files/documents/Letters/2020.09.01%20--%20Pro-Life%20Mifeprex%20Letter%20to%20FDA%20-%20FSV.pdf [https://perma.cc/ZTS5-YDRK] (requesting that the FDA reclassify mifepristone as an “’imminent hazard to the public’ that poses ‘significant threat of danger’” in order to ban commercial access to the drug).

95 See Kulynych, Jennifer, Will FDA relinquish the “Gold Standard” for New Drug Approval? Redefining “Substantial evidence” in the FDA Modernization Act of 1997, 54 FOOD DRUG L.J. 127, 129 (1999).Google ScholarPubMed But see Tollefson, Jeff, How Trump Damaged Science – and Why it Could Take Decades to Recover, 856 NATURE 190, 194 (Oct. 7, 2020), https://www.nature.com/articles/d41586-020-02800-9 [https://perma.cc/4H52-QFK5]CrossRefGoogle Scholar; Letter from Senator Elizabeth Warren to Comptroller General Gene Dodaro (Oct. 8, 2020), https://www.warren.senate.gov/imo/media/doc/2020.10.08%20Letter%20to%20GAO%20re%20Scientific%20Integrity%20and%20Independence%20at%20FDA%20and%20CDC.pdf [https://perma.cc/FM4L-89HB] (requesting that the Government Accountability Office review allegations of political interference occurring in the FDA and CDC during the COVID-19 pandemic).