Abstract
Mifepristone, also known by the brand name Mifeprex, and misoprostol are part of a common two-drug medical abortion regimen approved by the United States Food and Drug Administration (“FDA”) to assist in the termination of pregnancy for up to ten weeks of gestation. 1 The FDA imposes distribution restrictions on certain drugs, like mifepristone, through the implementation of Risk Evaluation and Mitigation Strategy (“REMS”) and Elements to Assure Safe Use (“ETASU”) requirements. 2 The in-person dispensing and in-person signature requirements (“In-Person Requirements”) contained in the ETASU provisions of mifepristone’s REMS became increasingly difficult for patients and providers to satisfy during the COVID-19 pandemic. 3
On May 27, 2020, various medical associations and entities (“Plaintiffs”) challenged mifepristone’s In-Person Requirements by filing suit against several federal agencies and officials (“Government”), including the FDA, the Commissioner of Food and Drugs (“Commissioner”), the United States Department of Health and Human Services (“HHS”), and the Secretary of the HHS. 4 In American College of Obstetricians and Gynecologists (“ACOG”) v. FDA, the Plaintiffs brought forth fifth amendment substantive due process and equal protection claims challenging mifepristone’s In-Person Requirements, which had remained fully intact during the pandemic. 5 In support of these claims, the Plaintiffs referenced the ongoing and devastating impact of the COVID-19 pandemic, the lack of a medical basis for the FDA’s differential treatment of mifepristone prescribers and patients, and the widespread availability of telemedicine for reducing unnecessary medical encounters. 6
The United States District Court for the District of Maryland granted Plaintiffs a preliminary injunction enjoining the Government from enforcing mifepristone’s In-Person Requirements until thirty days after the Secretary of the HHS terminated the ongoing public health emergency declaration or until the case resolves. 7 The Government subsequently filed a motion for a stay of the preliminary injunction in the Fourth Circuit Court of Appeals, which denied the motion, and in the Supreme Court of the United States, which placed the motion in abeyance pending further consideration by the district court on the scope of the injunction. 8
I. STRICT IN-PERSON SAFEGAURDS REGULATE MIFEPRISTONE DISTRIBUTION
Since mifepristone’s approval in 2000, the FDA has increasingly restricted its distribution. 9 Following the passage of the FDA Amendments Act of 2007, the Food, Drug, and Cosmetic Act granted the FDA the authority to mandate REMS programs. 10 REMS is a designation allowing the FDA to impose restrictions on the distribution and administration of certain drug products, in addition to the agency’s powers to regulate drug labeling. 11 After applying mifepristone’s first REMS designation in 2007, the FDA incorporated more stringent restrictions to the drug’s distribution in 2011 by adding ETASU components to the REMS. 12 ETASU is a “special category of REMS …. [that] can be imposed on a drug that has been ‘shown to be effective’ but is ‘associated with a serious adverse drug experience’ such that it can be approved only in the condition that the designated elements are satisfied.” 13 Three ETASU components in the mifepristone REMS require that: (1) “‘health care providers who prescribe the drug have particular training or experience or are specially certified’” (“ETASU A,” pursuant to 21 U.S.C. § 355-1(f)(3)(A)); (2) “mifepristone may be dispensed only in a hospital, clinic, or medical office, by or under the supervision of a certified healthcare provider” (“ETASU C,” pursuant to 21 U.S.C. § 355-1(f)(3)(C)); and (3) mifepristone is only “‘dispensed to patients with evidence or other documentation of safe-use conditions’” (“ETASU D,” pursuant to 21 U.S.C. § 355-1(f)(3)(D)). 14 ETASU D also requires that patients sign a Patient Agreement Form in the presence of the provider acknowledging that the patient reviewed the risks associated with mifepristone and received adequate counseling. 15
The In-Person Requirements in ETASU A, C, and D have not changed since their original implementation in 2011, though the FDA re-examined mifepristone’s ETASU and REMS requirements in 2013 and 2016. 16 In 2016, the mifepristone drug regimen was re-approved with additional guidance on dose, administration, and labeling, along with some minor modifications. 17 The modifications were made in light of a determination by the FDA that: “‘no new safety concerns [regarding mifepristone] have arisen in recent years;’” “‘the known serious risks occur rarely;’” and “‘[g]iven that the numbers of … adverse events appear to be stable or decreased over time, it is likely that … serious adverse events will remain acceptably low.’” 18 No changes were made, however, to mifepristone’s In-Person Requirements, as such changes to the distribution requirements were neither requested nor reviewed. 19 The Plaintiffs identified the In-Person Requirements contained in ETASU A, C, and D as the main obstacles to medical abortion during the COVID-19 pandemic. 20 Specifically, these “medically unnecessary” ETASU provisions were alleged to jeopardize patient safety without providing any “countervailing benefit.” 21
II. IN-PERSON REQUIREMENTS WARRANT PRELIMINARY INJUNCTION DURING THE COVID-19 PANDEMIC
In late 2019, China reported the first case of SARS-CoV-2 transmission resulting in COVID-19, a highly infectious respiratory disease. 22 On March 13, 2020, the President of the United States declared the “COVID-19 outbreak … a national emergency.” 23 Prior to this, on January 31, 2020, the Secretary of the HHS declared a public health emergency in response to the outbreak. 24 As authorized by the Public Health Service Act, 42 U.S.C. § 247d (2018), the Secretary of the HHS can declare a public health emergency during “significant outbreaks of infectious diseases or bioterrorist attacks” in order to “‘take such action as may be appropriate to respond to the public health emergency.’” 25
Following the Secretary of the HHS’s declaration of a public health emergency, the Government (1) waived in-person restrictions for multiple drugs with ETASU requirements, (2) lifted mandatory testing and imaging safeguards for certain controlled substances, and (3) relaxed telemedicine guidance and regulations to ensure patients could receive needed care. 26 In-Person Requirements for mifepristone, however, were neither waived nor modified. 27 The Plaintiffs alleged that the In-Person Requirements had a significant and disproportionate effect on access to abortion services during the pandemic, in direct violation of patients’ and providers’ constitutional rights. 28
Plaintiffs sought a preliminary injunction preventing the Government from enforcing the In-Person Requirements “for the duration of the COVID-19 pandemic and until such time as … medically unnecessary travel to a health care facility no longer poses a significant threat of SARS-CoV-2 transmission and illness associated with COVID-19.” 29 As a preliminary injunction is “‘an extraordinary remedy,’” a moving party seeking such a remedy must establish a “clear showing” of four requisite factors. 30
Plaintiffs needed to establish that (1) the fifth amendment substantive due process and/or equal protection claims were likely to succeed on the merits; (2) the Plaintiffs were likely to suffer irreparable harm without such an injunction; (3) the “balance of equities” favored the Plaintiffs; and (4) an injunction would serve the public interest. 31
A. An Undue Burden on Patients ’ Constitutional Right to Abortion ?
Before determining the likelihood of any claim to succeed on the merits, the district court first addressed standing concerns raised by the Government. The Government argued that the alleged threat of injury was insufficient to meet Article III “Cases” or “Controversies” requirements for standing, as the health care providers that the Plaintiffs represented lacked the ability to bring forward the suit in their own right. 32 The Government asserted that the Plaintiffs would be unable to assert third-party standing to seek relief for their patients’ constitutional right to abortion, even if injury-in-fact requirements were sufficiently established. 33 To satisfy requisite thresholds for third-party standing with regard to the substantive due process claim, the Plaintiffs had to successfully demonstrate a close relationship to the third-parties experiencing some hindrance in their ability to protect interests. 34 After duly noting that “courts have routinely recognized categorically that abortion and reproductive health care providers and physicians have third-party standing to assert the rights of their patients,” the district court successfully established the Plaintiffs’ standing by analyzing the testimony of an individual OB/GYN member belonging to one of the Plaintiff medical associations. 35 The district court then proceeded to assess the merits of the substantive due process claims.
The Supreme Court first recognized a constitutional right to obtain an abortion in Roe v. Wade by finding that “the right of personal privacy includes the abortion decision.” 36 Since Planned Parenthood of Southeastern Pennsylvania v. Casey, the Supreme Court has repeatedly utilized an “undue burden” standard to assess alleged violations of the constitutional right to abortion. 37 The undue burden standard for assessing an “unconstitutional infringement on a woman’s fundamental right of privacy” requires an inquiry into “‘the purpose or effect of placing a substantial obstacle … [especially] [u]nnecessary health regulations … in the path of a woman seeking an abortion of a nonviable fetus.’” 38 The undue burden standard takes into consideration “the burdens a law imposes on abortion access together with the benefits those laws confer,” to determine if abortion regulations impose a “substantial obstacle” on a “large fraction” of “those women for whom the provision ‘is an actual rather than an irrelevant restriction.’” 39 For the claim to succeed on its merits, the undue burden test would require a finding that a substantial obstacle is imposed on “women seeking a [medical] abortion through the Mifepristone-Misoprostol Regimen during the COVID-19 pandemic but who do not, based on their healthcare provider’s medical judgment, actually require an in-person visit with their healthcare provider.” 40
Despite the Government’s arguments against the use of the undue burden standard, the district court supported the use of the undue burden test, given the fact that (1) the Supreme Court repeatedly applied the undue burden test to abortion cases and (2) the undue burden test could be used to assess the Plaintiffs’ “as applied” challenge to abortion regulations. 41 The Government also argued that if the undue burden standard was to be applied, the district court should consider only the burdens—not the benefits—of the regulation in relation to abortion access. 42 The district court, however, found that precedent reaffirmed the use of a balancing test to weigh burdens and benefits when applying the undue burden standard. 43 Furthermore, in response to the Government’s arguments that there is no undue burden when there are alternative methods available to seek an abortion, the district court determined that “a burden does not need to be ‘absolute to be undue.’” 44
In initially assessing the burden imposed on patients, the district court found that the Government had previously acknowledged the significant burden that the pandemic imposed on travel, when the Government waived the in-person restrictions of other drugs and took measures to advance telemedicine. 45 Furthermore, the district court found that the extraordinary circumstances of the pandemic gave rise to substantial challenges—including transportation, childcare, and economic challenges—that could delay patients from accessing mifepristone until after the tenth week of gestation, in which case medical abortion is no longer an option. 46 In conducting a benefits analysis, the district court found that the Plaintiffs had sufficiently presented evidence that the In-Person Requirements were likely to qualify as “‘unnecessary health regulations,’” given the widespread availability of telemedicine. 47 The district court also concluded that “commonsense inferences” sufficiently established that the In-Person Requirements imposed a substantial obstacle for a “large fraction” of patients seeking a medical abortion during the COVID-19 pandemic who did not otherwise require an in-person consultation. 48 Therefore, the district court concluded that the Plaintiffs were likely to succeed on the merits of their due process claim, as a significant obstacle to abortion access could be established due to the lack of significant “health-related benefit[s]” and the presence of “serious burdens imposed by the In-Person Requirements during the COVID-19 pandemic.” 49
After considering the merits of the Plaintiffs’ substantive due process claim, the district court also had to make determinations regarding: (1) whether there would be irreparable harm in the absence of preliminary relief; (2) whether the balance of equities favored an injunction; and (3) whether the injunction would serve the public interest. 50 The district court found that, during the COVID-19 pandemic, mifepristone’s In-Person Requirements infringed on a constitutional right and, therefore, resulted in irreparable harm. 51 Despite the Government’s assertions that in-person visits did not pose significant risk of COVID-19 transmission, the district court found that in-person visits imposed substantial obstacles to medical abortions by promoting delays that could result in the patient no longer being eligible for the service, given the time-sensitive nature of medical abortions. 52 The Government also attempted to assert that the balance of equities was not in the Plaintiffs’ favor, by emphasizing that the role of the FDA’s expert judgment in implementing safeguards regulating mifepristone distribution. 53 However, the district court noted that the FDA’s judgement regarding In-Person Requirements was last reviewed in 2013, and new considerations apart from the pandemic—like the 2016 modifications to mifepristone’s REMS and the increased accessibility of telemedicine—might warrant the FDA to revise its judgement. 54 Furthermore, the district court noted that individual medical providers could still use their own expert judgement to require an in-person visit when necessary, even without mifepristone’s In-Person Requirements being enforceable. 55 Given the irreparable harm on patients’ constitutional rights and the lack of harm to Government in enforcing a preliminary action, the district court found that the balance of equities tipped in the Plaintiffs’ favor. 56 Lastly, given the public interest in protecting constitutional rights and “safeguarding public health,” the district court concluded that a preliminary injunction was warranted. 57
B. Discriminatory Treatment of Mifepristone Patients and Providers ?
After establishing that the substantive due process claim would warrant a preliminary injunction, the district court was reluctant to consider an equal protection claim related to the constitutional right to abortion; so it limited its analysis to “the likelihood of success of the equal protection claim as applied to miscarriage treatment only.” 58 The Plaintiffs’ equal protection claim was based on a theory that the In-Person Requirements maintained during the pandemic violated the equal protection clause by imposing “a unique barrier provision of mifepristone without any rational government interest justifying … discriminatory treatment.” 59 The Plaintiffs specifically alleged that patients and providers involved in the distribution of mifepristone were disproportionately burdened because similar restrictions for other prescription drugs had been waived. 60 Despite satisfaction of standing requirements, however, the district court found that there was likely insufficient evidence to support the Plaintiffs’ equal protection claim using a rational basis test, due to a lack of sufficiently “similarly situated” drugs “and by extension the [lack of similarly situated] individuals involved in the dispensing of those drugs.” 61 As the Plaintiffs’ claim was unlikely to succeed on the merits, the equal protection claim could not be used to justify a preliminary injunction. 62 The district court’s finding regarding the insufficiency of the equal protection claim, however, was largely insignificant, as the district court had already determined that the Plaintiffs’ substantive due process claim met the requisite threshold for granting a preliminary injunction.
III. GRANTING BROAD RELIEF TO ENSURE ACCESS TO MEDICAL ABORTION
After finding that the threshold requirements for granting a preliminary injunction were met, the district court addressed the scope of the preliminary injunction. 63 The Government noted concerns that nationwide relief would be inappropriate given that levels of risk varied largely depending on individual risk factors and location. 64 The district court, however, found that categorical relief was warranted to address the burden imposed by mifepristone’s In-Person Requirements, which categorically applied to “all healthcare providers and patients involved in prescribing of mifepristone, regardless of individual circumstances.” 65
In considering the appropriate scope of the injunction, the district court noted that patients of mifepristone represent a “vulnerable, and often invisible, class,” which is both consistently prevented from seeking relief due to privacy concerns and disproportionately affected by the COVID-19 pandemic. 66 The district court also noted that practicality issues would arise from an injunction that limited relief to Plaintiffs. The district court specifically noted concerns that: (1) suits brought by non-plaintiffs would be largely duplicative and (2) enforcement of a plaintiffs-only injunction would be difficult to administer, as only 10% of OB/GYN physicians in the United States did not belong to the various medical associations and entities represented as Plaintiffs. 67 Hence, a preliminary injunction was granted to “bar FDA enforcement of the In-Person Requirements against Plaintiffs, their members, and similarly-situated individuals, without geographic limitation.” 68 Finding that the Secretary of the HHS’s public health emergency was “an objectively identifiable marker that the COVID-19 pandemic continues to have a significant impact on the nation warranting emergency relief,” the district court granted the preliminary injunction for the entire duration of the public health emergency. 69 By granting the preliminary injunction, the district court allowed: (1) mifepristone to “be mailed or delivered to patients” and (2) providers to have patients sign the “Patient Agreement Form during a telemedicine session,” though compliance with other REMS requirements remained mandatory. 70
In challenging the preliminary injunction through a motion for stay pending appeal to the appeals court and, later, to the Supreme Court, the Government argued that the district court should have found that the substantive due process claim was unlikely to succeed on the merits. 71 Specifically, the Government asserted that the district court misapplied the third-party standing doctrine, erred in determining that mifepristone’s In-Person Requirements posed an undue burden on abortion rights, and mistakenly applied a flawed “large fraction” standard for assessing challenges to abortion regulations. 72 Regarding the district court’s third-party standing analysis, the Government took issue with the district court’s reliance on: (1) a single physician’s declaration for evidence establishing a close physician-patient relationship and (2) general observations about abortion patients to ascertain hindrance, despite no categorical rule existing “that abortion providers always have third-party standing to represent their patients.” 73
The Government also challenged the district court’s undue burden analysis by asserting that it inappropriately concluded that mifepristone’s In-Person Requirements did not present a substantial obstacle to abortion access. Specifically, the Government argued that: (1) “a regulation ‘does not construct a substantial obstacle to the abortion right’ when… [there are] other ‘commonly used and generally accepted method[s];’” (2) incidental effects of the pandemic do not render a regulatory requirement unconstitutional when the regulation has an otherwise valid purpose; and (3) one-time visits to clinics adhering to CDC guidelines do not impose substantial obstacles to abortion. 74 The Government also argued that the district court: (1) incorrectly balanced the In-Person Requirement’s burdens and benefits and (2) incorrectly applied the “large fraction” standard. 75 The district court claimed that, in “‘as applied’” challenges, the district court must assess whether substantial obstacles affected “all or a specified subset of [Plaintiffs’] members during the pandemic—not merely a large fraction of them.” 76
The Government also challenged the district court’s ruling by asserting that the district court engaged in “judicial second-guessing that is especially inappropriate during a public health emergency … [and] causes irreparable harm to the government and the public interest.” 77 At minimum, the Government argued, the injunction was overbroad and inappropriately tailored. 78
The Government’s request for a stay, however, was denied by the appeals court in a one-sentence order. 79 The Government then applied for a stay of the preliminary injunction to the Supreme Court. 80 On October 8, 2020, in an unsigned order, the Supreme Court announced that it would “hold the Government’s application in abeyance,” given the Government’s argument that the preliminary injunction may be overly broad in scope. 81
IV. THE FUTURE OF THE SUPREME COURT AND ABORTION CARE IN THE UNITED STATES
Rates of medical abortion have been steadily increasing, even as rates of abortion, overall, have decreased in the United States. 82 Mifepristone’s In-Person Requirements impose burdens on abortion access that are not limited to the jurisdictions that imposed temporary bans on abortion-related surgical procedures in response to the COVID-19 pandemic, as all of these bans are now no longer in effect. 83 Even prior to the COVID-19 pandemic, the ACLU brought a different suit on account of the undue burden of mifepristone’s REMS requirements on a woman’s right to abortion. 84 The plaintiffs in the 2017 complaint alleged that the entirety of the REMS requirements violate the fifth amendment and the Administrative Procedure Act. 85 Meanwhile, in ACOG v. FDA, the focus of the complaint regards only mifepristone’s In-Person Requirements, which were generally considered minor obstacles to abortion services prior to the pandemic. 86
By granting an abeyance of the Government’s application for a stay of an injunction, the Supreme Court allowed the district court to continue enjoining the FDA from enforcing In-Person Requirements for mifepristone until a judgement could be made recognizing the changing circumstances of the public health emergency. 87 The Supreme Court, however, did not provide any indication of “its views on the merits of the district court’s order or injunction,” though, in the wake of the pandemic, Chief Justice Roberts specifically “admoni[shed] … judicial second-guessing of officials with public health responsibilities.” 88 The Supreme Court has previously also “repeatedly emphasize[d] the institutional advantages of a regulatory scheme enforced by such an expert agency as the FDA … and herald[ed] the FDA’s broad perspective on larger public health goals.” 89
In their dissent, Justice Alito and Justice Thomas attribute the Supreme Court’s reluctance in “[e]xpressly denying a stay” to the fact that such an action “would highlight the inconsistency in the [Supreme] Court’s rulings on COVID–19-related public safety measures, [as]… [u]nder the approach recently taken by the [Supreme] Court in cases involving restrictions on First Amendment rights, the proper disposition of the Government’s stay application should be clear: grant.” 90 As the abeyance has effectively delayed the necessity for any Supreme Court ruling on the preliminary injunction until after the 2020 presidential election, ACOG v. FDA will potentially be one of the first abortion cases a new court hears following Justice Barrett’s appointment as Justice Ginsburg’s successor. If true, ACOG v. FDA could signal changing tides in the Supreme Court’s attitude towards abortion.
At present, the Supreme Court has deferred any ruling until the Government files a motion in the district court to modify the preliminary injunction’s scope; the district court has forty days to rule after receiving the motion. 91 Yet, even if the district court permanently enjoined the FDA from enforcing mifepristone’s In-Person Requirements, related barriers on medical abortion would still remain an issue in several states. After all, eighteen states have policies that restrict the use of telemedicine for provision of abortion services. 92 Of these states, six states—Arizona, Arkansas, Idaho, Missouri, Louisiana, and West Virginia—explicitly ban the use of telemedicine for rendering or facilitating abortion-related services. 93
If all REMS restrictions on mifepristone are upheld, there are some concerns that political interference may result in additional restrictions on mifepristone being imposed by the FDA. 94 This result is unlikely to happen, however, as the FDA largely maintains its reputation as the gold standard of review, despite recent allegations of political interference. 95
Footnotes
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, N
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, W
]).
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, G] (noting that, in 2017, 39% of all abortions that were performed in the United States were early medical abortions); see also Tara Jatlaoui et al., Abortion Surveillance – United States 2016, 68 M
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/ [].
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; Catherine Sharkey, The Anti-Deference Pro-Preemption Paradox at the U.S. Supreme Court: The Business Community Weighs In, 67 C
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/ [].
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 [] (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 Jennifer Kulynych, 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). But see Jeff Tollefson, How Trump Damaged Science – and Why it Could Take Decades to Recover, 856 NATURE 190, 194 (Oct. 7, 2020), https://www-nature-com-s.web.bisu.edu.cn/articles/d41586-020-02800-9 [https://perma.cc/4H52-QFK5]; 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 [] (requesting that the Government Accountability Office review allegations of political interference occurring in the FDA and CDC during the COVID-19 pandemic).