The New Major Questions Doctrine

This Article critically analyzes significant recent developments in the major questions doctrine. It highlights important shifts in what role the “majorness” of an agency policy plays in statutory interpretation, as well as changes in how the Court determines whether an agency policy is major. After the Supreme Court’s October term 2021, the “new” major questions doctrine operates as a clear statement rule that directs courts not to discern the plain meaning of a statute using the normal tools of statutory interpretation, but to require explicit and specific congressional authorization for certain agency policies. Even broadly worded, otherwise unambiguous statutes may not be good enough when it comes to policies the Court deems “major.”

At the same time, the Court has increasingly relied on three new indicia of majorness to determine whether an agency policy is major: the political significance of or political controversy surrounding the policy; the novelty of the policy; and the possibility that other, supposedly even more controversial agency policies might be supported by the agency’s broader statutory rationale.

Understanding how the major questions doctrine operates today is important not only to bring a modicum of clarity to a doctrine often described as radically indeterminate. Unpacking the new major questions doctrine also provides a way to interrogate and evaluate the doctrine and to assess how it relates to, and enforces, previously understood institutional and political pathologies. In particular, this Article argues that the new major questions doctrine allows the presence of present-day political controversy surrounding a policy to alter otherwise broad regulatory statutes outside of the formal legislative process. It supplies an additional means for minority rule in a constitutional system that already skews toward minority rule. What’s more, it invites politically infused judgments by the federal courts, further eroding democratic control of policy. And it operates as a powerful de-regulatory tool that limits or substantially nullifies congressional delegations to agencies in the circumstances where delegations are more likely to be used—and more likely to be effective—even as the Court claims it is simply doing statutory interpretation.

Introduction

Stymieing agency efforts to address issues from climate change to the COVID-19 pandemic,1.See West Virginia v. EPA, 142 S. Ct. 2587 (2022) (invoking major questions doctrine to invalidate EPA regulation designed to curb emissions from greenhouse gasses); Nat’l Fed’n of Indep. Bus. v. Dep’t of Labor, Occupational Safety & Health Admin., 142 S. Ct. 661 (2022) [hereinafter NFIB v. OSHA] (invoking major questions doctrine to invalidate Occupational Safety and Health Administration (“OSHA”) regulation designed to address COVID-19).Show More the major questions doctrine has emerged as a powerful weapon wielded against the administrative state.2.See, e.g., Alison Gocke, Chevron’s Next Chapter: A Fig Leaf for the Nondelegation Doctrine, 55 U.C. Davis L. Rev. 955, 994 (2022) (“The legal fictions underlying the major questions doctrine (specifically, the ‘major questions doctrine as Chevron step zero test’) and Chief Justice Roberts’ jurisdictional exception are poised to become the Court’s new nondelegation tests.”); Lisa Heinzerling, The Power Canons, 58 Wm. & Mary L. Rev. 1933, 1937–38 (2017) (arguing that the Court’s earlier major questions cases diverted power to courts and away from administrative agencies).Show More The doctrine’s roots extend as far back as 2000 and arguably before.3.See Michael Coenen & Seth Davis, Minor Courts, Major Questions, 70 Vand. L. Rev. 777, 787 (2017) (“Though it had precursors, the majorness inquiry first crystallized in FDA v. Brown & Williamson Tobacco Corp.”).Show More But its shape has morphed significantly over time.4.See Cass R. Sunstein, There Are Two “Major Questions” Doctrines, 73 Admin. L. Rev. 475, 481–83 (2021) [hereinafter Sunstein, Two “Major Questions” Doctrines] (arguing that the Court has deployed two different formulations of the doctrine).Show More Most recently, the Supreme Court’s October term 2021 saw the doctrine become stronger, more powerful. At the same time, the Court more fully articulated its vision of when the doctrine applies. And at least one thing has become crystal clear: the major questions doctrine has become an important—perhaps the most important—constraint on agency power, particularly when it comes to some of the most pressing problems of our time.

This Article critically analyzes significant recent developments in the major questions doctrine. It highlights important shifts in what role the “majorness” of an agency policy plays in statutory interpretation, as well as changes in how the Court determines whether an agency policy is major. The major questions doctrine originally operated within the familiar Chevron framework.5.See Coenen & Davis, supra note 3, at 788–91 (describing doctrinal origins and operation). On Chevron, see infra notes 45–67 and accompanying text.Show More When an agency promulgated a policy that was dramatic or unexpected, the broader context of the statute, consulted in conjunction with common sense, might indicate that the statute unambiguously foreclosed that policy.6.See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 137, 160 (2000) (rejecting the FDA’s attempt to regulate cigarettes in part because of the vast economic impacts of the tobacco industry and the “cryptic” statutory provision at issue). In a slightly different form, the doctrine operated to inform the courts’ analysis of whether the agency’s interpretation was a reasonable one. See Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 321 (2014).Show More In such form, the major questions doctrine (a phrase the Court did not use until last term) was simply one tool of statutory interpretation, sitting alongside others in the tool kit such as ordinary meaning and the semantic canons.

But it has become something quite different. First, in King v. Burwell, the Court used the doctrine as a reason why courts should determine the meaning of statutory language without any deference to the agency’s views.7.576 U.S. 473, 485–86 (2015).Show More And now, after the October term 2021, the “new” major questions doctrine operates as a clear statement rule.8.See West Virginia v. EPA, 142 S. Ct. 2587, 2616 (2022) (Gorsuch, J., concurring) (describing the Court’s articulation of the major questions doctrine as a clear statement rule); id. at 2641 (Kagan, J., dissenting) (describing the major questions doctrine as a “get-out-of-text-free card[]”).Show More It directs courts not to discern the plain meaning of a statute using the normal tools of statutory interpretation, but instead to require explicit and specific congressional authorization for certain agency policies.9.See id. at 2633–34, 2641 (Kagan, J., dissenting).Show More Even broadly worded, otherwise unambiguous statutes may not be good enough when it comes to policies the Court deems “major.”

At the same time, the Court has increasingly relied on three indicia of majorness, in addition to the costs imposed by the agency policy, to determine whether an agency rule is major. First, the Court has indicated that politically significant or controversial policies are more likely to be major and thus require clear authorization.10 10.See NFIB v. OSHA, 142 S. Ct. 661, 665 (2022) (quoting Ala. Ass’n of Realtors v. Dep’t of Health & Hum. Servs., 141 S. Ct. 2485, 2489 (2021)); West Virginia v. EPA, 142 S. Ct. at 2620 (Gorsuch, J., concurring) (explaining that an issue may be major where “certain States were considering” the issue or “when Congress and state legislatures were engaged in robust debates”); id. at 2614 (majority opinion).Show More Second, the Court has signaled that the novelty of a policy—i.e., the fact that the agency had never promulgated a similar policy before—is a reason to think that the policy is a major one.11 11.See West Virginia v. EPA, 142 S. Ct. at 2595–96 (invoking novelty of the regulation as an indicium of majorness); NFIB v. OSHA, 142 S. Ct. at 666 (“This ‘lack of historical precedent,’ coupled with the breadth of authority that the Secretary now claims, is a ‘telling indication’ that the mandate extends beyond the agency’s legitimate reach.” (internal quotation marks omitted) (quoting Free Enter. Fund v. Pub. Co. Acct. Oversight Bd., 561 U.S. 477, 505 (2010))).Show More Finally, the Court has considered the majorness of other, theoretically possible agency policies not actually before the Court but that might be supported by the agency’s broader rationale in determining whether the agency’s current claim of interpretive authority is major.12 12.See Ala. Ass’n of Realtors, 141 S. Ct. at 2489 (using implications of agency’s theory of authority as indicia of majorness).Show More (Although we describe these developments in the doctrine at the Court, it is the Republican appointees on the Court who are in the majority in the relevant cases.)

This new major questions doctrine was most clearly on display in the Supreme Court’s end-of-term blockbuster decision in West Virginia v. EPA.13 13.142 S. Ct. at 2595.Show More There, the Court invoked the major questions doctrine to invalidate an EPA regulation requiring coal-fired power plants to adopt so-called “generation shifting” methods in order to shift production to cleaner sources of electricity.14 14.See id.; see also Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units, 80 Fed. Reg. 64662, 64728 (Oct. 23, 2015).Show More The case was the first time the Court actually used the phrase “major questions doctrine,” and it represents the full emergence of the doctrine as a clear-statement rule.15 15.West Virginia v. EPA, 142 S. Ct. at 2634 (Kagan, J., dissenting). Justice Gorsuch labeled the doctrine as a clear statement rule in his concurrence. See id. at 2622 (Gorsuch, J., concurring).Show More The consequence is that “major” agency policies now require “clear congressional authorization”—even broadly worded, otherwise unambiguous statutes may not do.16 16.See id. at 2609 (majority opinion) (quoting Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014)).Show More

West Virginia v. EPA also displayed the Court’s new indicia of majorness—the criteria used to assess whether the doctrine applies. The Court made clear that the “political significance” of a rule is evidence of majorness,17 17.Id. at 2595 (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 159–60 (2000)).Show More pointing to political disagreement over whether to adopt generation shifting programs.18 18.Id. at 2614 (“‘The importance of the issue,’ along with the fact that the same basic scheme EPA adopted ‘has been the subject of an earnest and profound debate across the country, . . . makes the oblique form of the claimed delegation all the more suspect.’” (quoting Gonzales v. Oregon, 546 U.S. 243, 267–68 (2006))).Show More The concurrence, which agreed with the Court’s application of the major questions doctrine, underscored that the agency’s rule was major because “certain States were considering” the issue and “Congress and state legislatures were engaged in robust debates.”19 19.Id. at 2620 (Gorsuch, J., concurring).Show More The Court also invoked the novelty of the agency’s regulatory approach in finding it to be a major one,20 20.See id. at 2596 (majority opinion).Show More and it considered the possible future implications of the agency’s theory of its statutory authority.21 21.See id. at 2612 (“[T]his argument does not so much limit the breadth of the Government’s claimed authority as reveal it.” (emphasis omitted)).Show More These trends continued in the October term 2022.22 22.See Biden v. Nebraska, 143 S. Ct. 2355 (2023).Show More

Understanding how the major questions doctrine operates today is important not only to bring a modicum of clarity to a doctrine often described as radically indeterminate.23 23.See, e.g., Heinzerling, supra note 2, at 1938–90 (describing uncertainty in the major questions doctrine); Gocke, supra note 2, at 1002 (describing the major questions doctrine as “illusory”); Coenen & Davis, supra note 3, at 809–10 (describing lack of clarity in the major questions doctrine); Jonas J. Monast, Major Questions About the Major Questions Doctrine, 68 Admin. L. Rev. 445, 448 (2016) (“More is unclear than clear about the bounds of the major questions doctrine at this stage.”); Jacob Loshin & Aaron Nielson, Hiding Nondelegation in Mouseholes, 62 Admin. L. Rev. 19, 45 (2010) (describing a related interpretive principle as applied “haphazardly”); Natasha Brunstein & Richard L. Revesz, Mangling the Major Questions Doctrine, 74 Admin. L. Rev. 217, 218 (2022) (“What constitutes a major question is as unclear today as it was when Justice Breyer wrote those words in 1986.”); Nathan Richardson, Antideference: COVID, Climate, and the Rise of the Major Questions Canon, 108 Va. L. Rev. Online 174, 195 (2022) (“The most prominent critique of the major questions doctrine has been that its boundaries are unclear, unpredictable, and arbitrary.”).Show More Unpacking the new major questions doctrine also allows us to normatively evaluate the doctrine on its own terms and to assess how it relates to, and enforces, previously understood institutional and political pathologies. And we will suggest that, judged in this manner, the doctrine does quite poorly.

This Article makes three principal contributions. The first is descriptive and synthetic: the Article offers the first account of how the new major questions doctrine operates in light of the Supreme Court’s decisions from October term 2021, showing how it has emerged as a clear-statement rule and cataloguing the new indicia of majorness.

The Article’s second contribution is analytic: identifying how the Court assesses majorness makes it easier to evaluate the new major questions doctrine and to critically assess its potential consequences. Specifically, we suggest that the Court’s new approach may allow present-day political controversy surrounding a policy to restrict authority that agencies would otherwise have under broadly worded statutes. This permits political parties and political movements more broadly—and whether as part of a conscious strategy or not—to effectively amend otherwise broad regulatory statutes by generating controversy surrounding an agency policy. This dynamic undermines the purported purpose of the doctrine, which is to channel policy disputes into legislatures.

The third contribution is more straightforwardly normative: unpacking the new major questions doctrine identifies how the doctrine reinforces previously identified pathologies of the American constitutional system and undermines public policy by hobbling delegations when they are most likely to be effective. We argue that the doctrine supplies an additional means for minority rule in a constitutional system that already skews toward minority rule. It provides an additional mechanism for courts to exercise what is essentially political oversight of statutes—inviting judges to opine on what policies are sufficiently controversial and thus require special authorization, an inquiry that may often depend on the judges’ own deeply held politics.24 24.Cf. Coenen & Davis, supra note 3, at 831 (arguing that lower courts’ application of the version of the major questions doctrine articulated in King v. Burwell raised “concerns about major political dysfunction and institutional breakdowns”).Show More And it operates to kneecap delegations to agencies in precisely the circumstances in which Congress may have had particular reason to delegate broad authority to agencies, all while supposedly simply doing statutory interpretation.

Now is an especially important time to unpack and assess the major questions doctrine. In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization overruling Roe v. Wade,25 25.Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022) (overruling Roe v. Wade, 410 U.S. 113 (1973)).Show More the federal government is reportedly considering and undertaking some administrative responses to secure access to abortion, particularly medication abortion.26 26.See Shira Stein, Fiona Rutherford & Celine Castronuovo, White House Touts Abortion Pill as Answer to Roe Reversal but FDA Rules Limit Use, Bloomberg (June 30, 2022, 11:57 AM), https://www.bloomberg.com/news/articles/2022-06-30/white-house-touts-abortion-pill‌-as-answer-to-roe-reversal-but-fda-rules-limit-use [https://perma.cc/DWZ3-K25Z]; Dan Diamond & Rachel Roubein, Biden Official Vows Action on Abortion Following ‘Despicable’ Ruling, Wash. Post (June 28, 2022, 1:28 PM), https://www.washingtonpost.com/‌health/2022/06/28/abortion-access-becerra/ [https://perma.cc/4UKJ-GXJ9].Show More Possible responses include regulatory action by the FDA27 27.See U.S. Food & Drug Admin., Information About Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information [https://perma.‌cc/G7Q4-VNU7] (last visited Jan. 24, 2023); U.S. Food & Drug Admin., Risk Evaluation and Mitigation Strategy (REMS) Single Shared System for Mifepristone 200MG (2019), https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14_REMS_Full.pdf [https://perma.cc/ULJ3-ZUET].Show More and declarations of public health emergencies under the Public Readiness and Emergency Preparedness Act.28 28.42 U.S.C. §§ 247d, 247d-6d(b)(1).Show More Both responses rely on statutory delegations to agencies.29 29.U.S. Gov’t Accountability Off., GAO-08-751, Approval and Oversight of the Drug Mifeprex 2 (2008), https://www.gao.gov/assets/ 280/279424.pdf [https://perma.cc/J63V-C6CY]; Memorandum from Ctr. for Drug Evaluation & Rsch. to Sandra P. Arnold, Vice President, Corp. Affs., Population Council, 1 (Sept. 28, 2000), https://www.accessdata.‌fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf [https://perma.cc/36XJ-FFZA]; 21 U.S.C. § 355-1(a)(1), (f)(2); id. § 355(b)(1), (d); 42 U.S.C. § 247d-6d(b).Show More These agency responses may be evaluated under the major questions doctrine, making it important to understand what the doctrine is and how it might be applied.30 30.Original Complaint at 12, Texas v. Becerra, No. 22-cv-00185, 2022 WL 18034483 (N.D. Tex. Nov. 15, 2022), ECF No. 1 (challenging Department of Health and Human Services Secretary Becerra’s post-Dobbs guidance on major questions grounds).Show More

The Article proceeds in four Parts. Part I provides a brief overview of different judicial constraints on administrative agencies’ authority to interpret and implement federal statutes. Part II provides a synthesis of the new major questions doctrine, focusing on three recent cases, two from the Supreme Court’s most recent term and the third from August 2021. Part III then critically evaluates the new major questions doctrine. We conclude by arguing the new major questions doctrine erodes the bases for several recently offered justifications for the exercise of agency power—and, perhaps from the standpoint of the doctrine’s defenders, maybe that’s the whole point.

  1.  See West Virginia v. EPA, 142 S. Ct. 2587 (2022) (invoking major questions doctrine to invalidate EPA regulation designed to curb emissions from greenhouse gasses); Nat’l Fed’n of Indep. Bus. v. Dep’t of Labor, Occupational Safety & Health Admin., 142 S. Ct. 661 (2022) [hereinafter NFIB v. OSHA] (invoking major questions doctrine to invalidate Occupational Safety and Health Administration (“OSHA”) regulation designed to address COVID-19).
  2.  See, e.g., Alison Gocke, Chevron’s Next Chapter: A Fig Leaf for the Nondelegation Doctrine, 55 U.C. Davis L. Rev. 955, 994 (2022) (“The legal fictions underlying the major questions doctrine (specifically, the ‘major questions doctrine as Chevron step zero test’) and Chief Justice Roberts’ jurisdictional exception are poised to become the Court’s new nondelegation tests.”); Lisa Heinzerling, The Power Canons, 58 Wm. & Mary L. Rev. 1933, 1937–38 (2017) (arguing that the Court’s earlier major questions cases diverted power to courts and away from administrative agencies).
  3.  See Michael Coenen & Seth Davis, Minor Courts, Major Questions, 70 Vand. L. Rev. 777, 787 (2017) (“Though it had precursors, the majorness inquiry first crystallized in FDA v. Brown & Williamson Tobacco Corp.”).
  4.  See Cass R. Sunstein, There Are Two “Major Questions” Doctrines, 73 Admin. L. Rev. 475, 481–83 (2021) [hereinafter Sunstein, Two “Major Questions” Doctrines] (arguing that the Court has deployed two different formulations of the doctrine).
  5.  See Coenen & Davis, supra note 3, at 788–91 (describing doctrinal origins and operation). On Chevron, see infra notes 45–67 and accompanying text.
  6.  See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 137, 160 (2000) (rejecting the FDA’s attempt to regulate cigarettes in part because of the vast economic impacts of the tobacco industry and the “cryptic” statutory provision at issue). In a slightly different form, the doctrine operated to inform the courts’ analysis of whether the agency’s interpretation was a reasonable one. See Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 321 (2014).
  7.  576 U.S. 473, 485–86 (2015).
  8.  See West Virginia v. EPA, 142 S. Ct. 2587, 2616 (2022) (Gorsuch, J., concurring) (describing the Court’s articulation of the major questions doctrine as a clear statement rule); id. at 2641 (Kagan, J., dissenting) (describing the major questions doctrine as a “get-out-of-text-free card[]”).
  9.  See id. at 2633–34, 2641 (Kagan, J., dissenting).
  10.  See NFIB v. OSHA, 142 S. Ct. 661, 665 (2022) (quoting Ala. Ass’n of Realtors v. Dep’t of Health & Hum. Servs., 141 S. Ct. 2485, 2489 (2021)); West Virginia v. EPA, 142 S. Ct. at 2620 (Gorsuch, J., concurring) (explaining that an issue may be major where “certain States were considering” the issue or “when Congress and state legislatures were engaged in robust debates”); id. at 2614 (majority opinion).
  11.  See West Virginia v. EPA, 142 S. Ct. at 2595–96 (invoking novelty of the regulation as an indicium of majorness); NFIB v. OSHA, 142 S. Ct. at 666 (“This ‘lack of historical precedent,’ coupled with the breadth of authority that the Secretary now claims, is a ‘telling indication’ that the mandate extends beyond the agency’s legitimate reach.” (internal quotation marks omitted) (quoting Free Enter. Fund v. Pub. Co. Acct. Oversight Bd., 561 U.S. 477, 505 (2010))).
  12.  See Ala. Ass’n of Realtors, 141 S. Ct. at 2489 (using implications of agency’s theory of authority as indicia of majorness).
  13.  142 S. Ct. at 2595.
  14.  See id.; see also Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units, 80 Fed. Reg. 64662, 64728 (Oct. 23, 2015).
  15.  West Virginia v. EPA, 142 S. Ct. at 2634 (Kagan, J., dissenting). Justice Gorsuch labeled the doctrine as a clear statement rule in his concurrence. See id. at 2622 (Gorsuch, J., concurring).
  16.  See id. at 2609 (majority opinion) (quoting Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014)).
  17.  Id. at 2595 (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 159–60 (2000)).
  18.  Id. at 2614 (“‘The importance of the issue,’ along with the fact that the same basic scheme EPA adopted ‘has been the subject of an earnest and profound debate across the country, . . . makes the oblique form of the claimed delegation all the more suspect.’” (quoting Gonzales v. Oregon, 546 U.S. 243, 267–68 (2006))).
  19.  Id. at 2620 (Gorsuch, J., concurring).
  20.  See id. at 2596 (majority opinion).
  21.  See id. at 2612 (“[T]his argument does not so much limit the breadth of the Government’s claimed authority as reveal it.” (emphasis omitted)).
  22.  See Biden v. Nebraska, 143 S. Ct. 2355 (2023).
  23.  See, e.g., Heinzerling, supra note 2, at 1938–90 (describing uncertainty in the major questions doctrine); Gocke, supra note 2, at 1002 (describing the major questions doctrine as “illusory”); Coenen & Davis, supra note 3, at 809–10 (describing lack of clarity in the major questions doctrine); Jonas J. Monast, Major Questions About the Major Questions Doctrine, 68 Admin. L. Rev. 445, 448 (2016) (“More is unclear than clear about the bounds of the major questions doctrine at this stage.”); Jacob Loshin & Aaron Nielson, Hiding Nondelegation in Mouseholes, 62 Admin. L. Rev. 19, 45 (2010) (describing a related interpretive principle as applied “haphazardly”); Natasha Brunstein & Richard L. Revesz, Mangling the Major Questions Doctrine, 74 Admin. L. Rev. 217, 218 (2022) (“What constitutes a major question is as unclear today as it was when Justice Breyer wrote those words in 1986.”); Nathan Richardson, Antideference: COVID, Climate, and the Rise of the Major Questions Canon, 108 Va. L. Rev. Online 174, 195 (2022) (“The most prominent critique of the major questions doctrine has been that its boundaries are unclear, unpredictable, and arbitrary.”).
  24.  Cf. Coenen & Davis, supra note 3, at 831 (arguing that lower courts’ application of the version of the major questions doctrine articulated in King v. Burwell raised “concerns about major political dysfunction and institutional breakdowns”).
  25.  Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022) (overruling Roe v. Wade, 410 U.S. 113 (1973)).
  26.  See Shira Stein, Fiona Rutherford & Celine Castronuovo, White House Touts Abortion Pill as Answer to Roe Reversal but FDA Rules Limit Use, Bloomberg (June 30, 2022, 11:57 AM), https://www.bloomberg.com/news/articles/2022-06-30/white-house-touts-abortion-pill‌-as-answer-to-roe-reversal-but-fda-rules-limit-use [https://perma.cc/DWZ3-K25Z]; Dan Diamond & Rachel Roubein, Biden Official Vows Action on Abortion Following ‘Despicable’ Ruling, Wash. Post (June 28, 2022, 1:28 PM), https://www.washingtonpost.com/‌health/2022/06/28/abortion-access-becerra/ [https://perma.cc/4UKJ-GXJ9].
  27.  See U.S. Food & Drug Admin., Information About Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information [https://perma.‌cc/G7Q4-VNU7] (last visited Jan. 24, 2023); U.S. Food & Drug Admin., Risk Evaluation and Mitigation Strategy (REMS) Single Shared System for Mifepristone 200MG (2019), https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2021_05_14_REMS_Full.pdf [https://perma.cc/ULJ3-ZUET].
  28.  42 U.S.C. §§ 247d, 247d-6d(b)(1).
  29.  U.S. Gov’t Accountability Off., GAO-08-751, Approval and Oversight of the Drug Mifeprex 2 (2008), https://www.gao.gov/assets/ 280/279424.pdf [https://perma.cc/J63V-C6CY]; Memorandum from Ctr. for Drug Evaluation & Rsch. to Sandra P. Arnold, Vice President, Corp. Affs., Population Council, 1 (Sept. 28, 2000), https://www.accessdata.‌fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf [https://perma.cc/36XJ-FFZA]; 21 U.S.C. § 355-1(a)(1), (f)(2); id. § 355(b)(1), (d); 42 U.S.C. § 247d-6d(b).
  30.  Original Complaint at 12, Texas v. Becerra, No. 22-cv-00185, 2022 WL 18034483 (N.D. Tex. Nov. 15, 2022), ECF No. 1 (challenging Department of Health and Human Services Secretary Becerra’s post-Dobbs guidance on major questions grounds).