Administrative Law Articles 139 Harv. L. Rev. 849

Drug Scheduling as Institutional Design

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Introduction

The Controlled Substances Act1 (CSA) recently turned fifty. It was not a happy birthday. The law’s half century as the “super-statute”2 at the center of psychoactive drug regulation in the United States has been marked by perverse consequences and profound injustices.3 During this period, more than a million Americans have died of drug overdoses, tens of millions have been arrested for drug offenses, and hundreds of millions have been channeled into illicit markets or denied access to needed substances.4 The CSA has not only failed to rationalize drug policy or advance public health but also contributed to a cascade of negative externalities, from the rise of mass incarceration and the subordination of Black and brown communities to the degradation of civil liberties and the delegitimation of the administrative state.5 Why should anyone trust the government to address a wicked problem like poverty or climate change if decades of vigorous efforts to address drug harms have yielded such dispiriting returns?

Broadly speaking, two types of legal scholarship have sought to make sense of the “abject failure”6 of the CSA and the war on drugs with which it became synonymous. One is sweeping in its critical and historical ambition — identifying ways in which deep social forces such as racism, moralism, and neoliberalism have shaped and been shaped by the country’s drug policies over time.7 The other familiar approach is granular and applied — asking whether the government has misclassified or misregulated particular substances, or whether a certain aspect of the CSA or related laws ought to be revised on one or another margin.8

Both strains of scholarship have generated crucial insights. All but absent from the literature, however, is theory in the “middle range”9 that interrogates the structure and assumptions of the CSA’s governance model, which assigns drugs to one of five “schedules” (or leaves them unscheduled) based on their potential for abuse and medical utility.10 More than five decades into its disastrous reign, as Professor Alex Kreit has noted, “almost nothing has been written about the classification and regulatory provisions” at the heart of the CSA.11 While drug law scholars have long debated the right schedule for marijuana12 and have recently begun to debate the right schedule for MDMA and other drugs,13 few have considered whether the CSA’s scheduling system is right in the first place or what a better designed system might look like.14 The regulatory regimes created by other super-statutes have been studied in depth.15 “Somehow, the underpinnings of our current drug policy have slipped through the cracks.”16

This Article begins to fill this gap by reconceptualizing drug policy as a question of institutional design and developing a pragmatic theory for regulating mind-altering drugs.17 We identify the CSA’s core design features and their underlying assumptions. We explain why these features have led to unintended consequences and will continue to do so unless changed. And, against the thrust of much drug scholarship and advocacy today, we suggest that reformers should seek to fix rather than abandon the law’s administrative framework for deciding how to regulate particular substances.

Foundational to our pragmatic theory of drug regulation are three features of psychoactive drugs that complicate institutional design.18 The prohibition problem is the best known: Most attempts to prohibit the sale or use of these drugs are bound to backfire, given both the inelasticity of consumer demand and the criminogenic, harm-enhancing effects of the prohibitions themselves. The “capital-P Prohibition”19 of alcohol is a canonical case in point.20 Yet, while the prohibition problem counsels a shift toward regulated access, the realities of drug misuse and addiction exacerbate the threat of private industry exploiting vulnerable parties and capturing the regulatory process — a threat that already looms large in the health care and consumer protection fields.21 Purdue Pharma’s role in driving the contemporary opioid crisis is illustrative.22 We call this the pharma problem. Administrative law’s go-to answer for capture concerns is to empower an independent agency to regulate with reduced political accountability.23 Whatever its merits in other contexts, however, this approach founders in the face of psychoactive drugs because of the pluralism problem. Politically insulated experts may be able to predict some of these drugs’ risks and benefits for some users. But their ability to set sociologically and normatively legitimate rules in the public interest is bedeviled by the radical epistemic uncertainty, value incommensurability, and cultural conflict associated with American drug debates.

On their own, the prohibition, pharma, and pluralism problems each make “ideal” drug regulation hard; collectively, they make it impossible. Small wonder, then, that drug policy remains stuck in a quagmire, with the CSA unable to curb dangerous drug behaviors and the federal marijuana rescheduling process unable to deliver a sustainable outcome.24 Sobering though this realization may be, it not only helps to clarify where the CSA went wrong but also offers lessons for redesigning the nation’s drug policy framework to better manage what cannot be solved. Taking seriously the regulatory challenges posed by the prohibition, pharma, and pluralism problems — and especially their interaction — yields a set of pragmatic imperatives. First, decisions about how to schedule drugs should be democratized through procedures that incorporate a wide range of interests and perspectives, including those of public health researchers and people who use or prescribe the drugs in question. Second, the scheduling system should include a means to legalize drugs while subjecting them to enhanced administrative controls that shield consumers from extractive capitalism.

These twinned imperatives provide cause for hesitation about the trend in drug policy and advocacy toward substance-specific legislative fixes, which satisfy neither of the two. Instead, the best path forward likely involves retaining the CSA’s categorical scheduling approach, which dilutes the influence of particular drug manufacturers and industries while promoting congressional and public engagement. Within this scaffolding, however, pragmatism counsels an array of changes, from revoking the Drug Enforcement Administration’s decisional authority and giving weight to “recreational” variables in the scheduling process to imposing new restrictions on lobbying and advertising by drug manufacturers and creating new schedules permitting but regulating nonmedical use. The details are complex and contestable, and we leave many for another day. More than anything else, we hope that the Article’s theory of drug regulation helps to stimulate and facilitate a comprehensive reassessment of the CSA’s institutional design, along with serious consideration of alternative models that would be far less punitive yet also far from laissez faire.25

The Article proceeds in four parts. Part I describes the regulatory theory embedded in the CSA’s scheduling scheme, which relies primarily on doctors and secondarily on law enforcement officers to manage the flow of potentially addictive drugs. Part II explicates the prohibition, pharma, and pluralism problems and the dilemmas they create for drug regulation. To navigate these problems, Part III suggests a range of reforms to the CSA’s scheduling scheme that would swap idealism for pragmatism, professional control for political accountability, exclusion for participation, and criminal sanctions for checks on capture and commercialism. Finally, Part IV addresses potential objections on grounds of feasibility and constitutionality.

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Footnotes
  1. ^ Pub. L. No. 91-513, tit. II, 84 Stat. 1242 (1970) (codified as amended at 21 U.S.C. §§ 801–904).

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  2. ^ William N. Eskridge, Jr., & Kevin S. Schwartz, Feature, Chevron and Agency Norm-Entrepreneurship, 115 Yale L.J. 2623, 2624 (2006) (describing the CSA as a “super-statute[]”).

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  3. ^ By “psychoactive drugs,” we refer broadly to nonfood “substances that, when taken in or administered into one’s system, affect mental processes” such as “perception, consciousness, cognition[,] or mood and emotions.” Drugs (Psychoactive), World Health Org., https://www.who.int/health-topics/drugs-psychoactive [https://perma.cc/5R6S-455W].

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  4. ^ See, e.g., David Pozen, The Constitution of the War on Drugs 14, 151–52 (2024) (explaining that marijuana alone generated over eight million arrests in the United States in the 2000s and that survey data from that decade indicated illegal drug use by over 100 million Americans); Brian Mann, More than a Million Americans Have Died from Overdoses During the Opioid Epidemic, NPR (Dec. 30, 2021, at 10:26 ET), https://www.npr.org/2021/12/30/1069062738/more-than-a-million-americans-have-died-from-overdoses-during-the-opioid-epidemi [https://perma.cc/2QJP-NFFB] (reporting opioid overdose death estimates); Ike Swetlitz, Adderall’s Disappearing Act Has Left Millions Without Treatment, Bloomberg (Feb. 16, 2023, at 09:00 ET), https://www.bloomberg.com/news/articles/2023-02-16/adderall-shortage-2023-teva-s-adhd-drug-is-missing-for-millions-of-americans [https://perma.cc/P4TK-K82F] (discussing recent Adderall shortages).

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  5. ^ Vast literatures address these disappointments and disasters. For a cogent summary, see Jennifer D. Oliva & Taleed El-Sabawi, The “New” Drug War, 110 Va. L. Rev. 1103, 1118–26 (2024). See also Jeffrey Friedman, The Legitimacy Crisis, Niskanen Ctr. (Oct. 4, 2017), https://www.niskanencenter.org/the-legitimacy-crisis [https://perma.cc/WLP2-URC3] (linking the U.S. government’s “legitimacy crisis” to the “ignominious” track record of the war on drugs).

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  6. ^ John F. Galliher, David P. Keys & Michael Elsner, Lindesmith v. Anslinger: An Early Government Victory in the Failed War on Drugs, 88 J. Crim. L. & Criminology 661, 681 (1998) (“[W]hile drug policy researchers may disagree on the best method of dealing with drug abuse, they nearly all agree that the current policy is an abject failure.”); see also andré douglas pond cummings & Steven A. Ramirez, The Racist Roots of the War on Drugs & the Myth of Equal Protection for People of Color, 44 U. Ark. Little Rock L. Rev. 453, 457–58 & nn.19–22 (2022) (collecting sources depicting U.S. drug policy as an “epic failure,” id. at 457).

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  7. ^ See generally, e.g., Michelle Alexander, The New Jim Crow: Mass Incarceration in the Age of Colorblindness (2010) (arguing famously that the drug war amounts to “[t]he New Jim Crow,” id. at 58); Bernard E. Harcourt, The Illusion of Free Markets: Punishment and the Myth of Natural Order 40–43, 202–08 (2011) (arguing that U.S. drug policy reflects a logic of “neoliberal penality,” id. at 41); David A. J. Richards, Sex, Drugs, Death, and the Law: An Essay on Human Rights and Overcriminalization 193 (1982) (arguing that “a formerly religious but now secular ideal of moral perfectionism” animates U.S. drug law).

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  8. ^ See, e.g., Barry Friedman & Genevieve Lakier, “To Regulate,” Not “to Prohibit”: Limiting the Commerce Power, 2012 Sup. Ct. Rev. 255, 286–320 (2013) (contending that the CSA should not apply to certain drug transactions that are permitted under state law); Erica Zunkel & Alison Siegler, The Federal Judiciary’s Role in Drug Law Reform in an Era of Congressional Dysfunction, 18 Ohio St. J. Crim. L. 283, 286–88 (2020) (reviewing criticisms of mandatory minimum penalties in federal drug laws that followed the CSA); Alyssa M. McClure, Note, Illegitimate Overprescription: How Burrage v. United States Is Hindering Punishment of Physicians and Bolstering the Opioid Epidemic, 93 Notre Dame L. Rev. 1747, 1766–70 (2018) (proposing that the CSA be amended to permit greater punishment of doctors with unsafe opioid prescribing practices).

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  9. ^ Robert K. Merton, Social Theory and Social Structure 39–40 (enlarged ed. 1968) (describing middle-range theories and noting that their “seminal ideas . . . are characteristically simple,” id. at 40).

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  10. ^ See Joanna R. Lampe, Cong. Rsch. Serv., R45948, The Controlled Substances Act (CSA): A Legal Overview for the 118th Congress 5–6 (2023) (“The heart of the CSA is its system for classifying controlled substances, as nearly all the obligations and penalties that the Act establishes flow from the classification system.” Id. at 5.).

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  11. ^ Alex Kreit, Controlled Substances, Uncontrolled Law, 6 Alb. Gov’t L. Rev. 332, 333 (2013).

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  12. ^ Cf. Pozen, supra note 4, at 54–66 (reviewing decades of constitutional challenges to marijuana’s placement in Schedule I of the CSA and state-level counterparts). This Article uses “marijuana” and “cannabis” interchangeably to refer to cannabis plants or products that contain more than trace amounts of the psychoactive chemical tetrahydrocannabinol (THC). On the etymology of “marijuana” in U.S. drug policy discourse and reasons to continue using the term, at least for now, see John Hudak, Marijuana: A Short History 23–26 (2d ed. 2020). See also Robert A. Mikos & Cindy D. Kam, Has the “M” Word Been Framed? Marijuana, Cannabis, and Public Opinion, PLOS One (Oct. 31, 2019), https://doi.org/10.1371/journal.pone.0224289 [https://perma.cc/6BGP-R6RL] (finding “no support for the notion that changing the name of the drug from ‘marijuana’ to ‘cannabis’ affects public opinion”).

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  13. ^ See, e.g., Mason M. Marks, Recent Development, Controlled Substance Regulation for the COVID-19 Mental Health Crisis, 72 Admin. L. Rev. 649, 711–12 (2020) (urging that MDMA be moved to Schedule IV or Schedule V and that psilocybin be descheduled); Nabil Al-Khaled, Note, MDMA and Psilocybin for Mental Health: Deconstructing the Controlled Substances Act’s Usage of “Currently Accepted Medical Use, 99 Wash. U. L. Rev. 1023, 1050–52 (2021) (urging that MDMA and psilocybin be removed from Schedule I).

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  14. ^ For an important recent exception, albeit with a much narrower focus than this Article’s, see Robert A. Mikos, Marijuana and the Tyrannies of Scheduling, 93 Fordham L. Rev. 473, 475–76 (2024) (arguing that the DEA “should stop insisting that a drug must be placed on Schedule I if it has no [currently accepted medical use],” id. at 475, and “propos[ing] a more flexible approach for determining whether a drug belongs on Schedule I,” id. at 476).

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  15. ^ See generally, e.g., Mark Barenberg, The Political Economy of the Wagner Act: Power, Symbol, and Workplace Cooperation, 106 Harv. L. Rev. 1379 (1993) (National Labor Relations Act); William N. Eskridge Jr. & John Ferejohn, The APA as a Super-Statute: Deep Compromise and Judicial Review of Notice-and-Comment Rulemaking, 98 Notre Dame L. Rev. 1893 (2023) (Administrative Procedure Act); David Schoenbrod, Goals Statutes or Rules Statutes: The Case of the Clean Air Act, 30 UCLA L. Rev. 740 (1983) (Clean Air Act).

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  16. ^ Kreit, supra note 11, at 333.

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  17. ^ In taking this approach, we aim to follow in the footsteps of scholars who have generated novel insights and lines of inquiry, and in some cases spurred significant policy change, by reconceptualizing other fields of law from the standpoint of institutional design. See generally, e.g., Oren Bar-Gill & Elizabeth Warren, Making Credit Safer, 157 U. Pa. L. Rev. 1 (2008) (consumer credit); Anne Joseph O’Connell, The Architecture of Smart Intelligence: Structuring and Overseeing Agencies in the Post-9/11 World, 94 Calif. L. Rev. 1655 (2006) (national security); David A. Weisbach & Jacob Nussim, The Integration of Tax and Spending Programs, 113 Yale L.J. 955 (2004) (tax). In describing our theory of drug regulation as “pragmatic,” we mean, most simply, that it emphasizes practicality over principle in solving problems. We further contend that the distinctive challenges of drug regulation make it an especially apt field in which to apply the method of pragmatism, emphasizing “usefulness, fallibility, empirically based experimentalism, and pluralism” in the pursuit of sustainable solutions. Clare Huntington, Pragmatic Family Law, 136 Harv. L. Rev. 1501, 1538 (2023) (identifying these as “core tenets” of pragmatism); see infra section III.A, pp. 879–82.

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  18. ^ On all points in this paragraph, see infra Part II, pp. 863–79. While versions of these features appear in other regulatory fields, we argue that they take an especially acute and challenging form in the context of psychoactive drugs.

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  19. ^ Pozen, supra note 4, at 156.

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  20. ^ See Lisa McGirr, The War on Alcohol: Prohibition and the Rise of the American State 250 (2016) (discussing the “wide consensus that Prohibition of the liquor traffic was a fundamentally flawed crusade with devastating consequences”); Pozen, supra note 4, at 156 (characterizing Prohibition as having been “relegated to the constitutional anticanon”).

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  21. ^ See, e.g., Rachel E. Barkow, Insulating Agencies: Avoiding Capture Through Institutional Design, 89 Tex. L. Rev. 15, 65 (2010) (describing consumer protection regulation as “the ideal breeding ground for agency capture and one-sided political pressure”); Liza Vertinsky, Pharmaceutical (Re)Capture, 20 Yale J. Health Pol’y L. & Ethics 146, 223 (2021) (describing “the myriad ways in which pharmaceutical companies exert influence over the construction and regulation of pharmaceutical markets”).

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  22. ^ For leading accounts of Purdue Pharma’s role in driving the crisis and the FDA’s failures in regulating OxyContin, see generally Patrick Radden Keefe, Empire of Pain: The Secret History of the Sackler Dynasty (2021), and Beth Macy, Dopesick: Dealers, Doctors, and the Drug Company that Addicted America (2018).

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  23. ^ See, e.g., Barkow, supra note 21, at 17 (“[T]he creation of an independent agency is often motivated by a concern with agency capture.”).

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  24. ^ As this Article was going to press, President Trump issued an executive order directing the Attorney General to “take all necessary steps to complete the rulemaking process related to rescheduling marijuana to Schedule III of the CSA in the most expeditious manner in accordance with Federal law, including 21 U.S.C. 811.” Exec. Order No. 14,370, 90 Fed. Reg. 60541, 60542 (Dec. 18, 2025). Prior to this intervention, the previously noticed hearing on marijuana rescheduling had been canceled by the presiding administrative law judge, with no new date set, Order Regarding Vill. Farms Int’l, Hemp for Victory, & OCO, et al.’s Motion to Reconsider, In re Schedules of Controlled Substances: Proposed Rescheduling of Marijuana, DEA Dkt. No. 1362, Hearing Dkt. No. 24-44, at 5 (Jan. 13, 2025) (order canceling hearing on the merits that had been scheduled for January 21, 2025), amid growing complaints that the DEA had sought to bias the hearing and growing recognition that moving marijuana to Schedule III may accomplish little, see Robert A. Mikos, The False Promise of Rescheduling, 60 Tulsa L. Rev. 1, 19–24 (2024). We discuss the problems with this rescheduling process to date and the implications for drug policy design in section III.B.3, pp. 890–94. Although we are unable to address the just-issued executive order, nothing in the order alters the analysis offered in that section.

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  25. ^ At the same time, we hope that the Article contributes to a number of adjacent literatures. First, while our focus is on the federal level, our pragmatic theory of drug regulation has significant implications for the states, all of which “have their own mini-CSAs that are pretty much lock-step with the federal CSA.” Marijuana as Schedule III: Woe Is Me?, Harris Sliwosky: Canna L. Blog (Sep. 6, 2023), https://harris-sliwoski.com/cannalawblog/marijuana-as-schedule-iii-woe-is-me [https://perma.cc/LYC6-5WEE]. Second, for those who lament that administrative law scholarship tends to privilege abstract, transsubstantive analyses, see, e.g., Sanne Knudsen, Sidestepping Substance: How Administrative Law Plays an Outsized Role in Shaping Environmental Policy and Why Recalibration Is Necessary, 76 Admin. L. Rev. 519, 531–36 (2024), this Article offers a relatively rare illustration of the value and methodology of applied institutional design. Third, and speaking to the transsubstantive strains of the public law literature, we explain ways in which scheduling regimes may offer an attractive hybrid of legislative delineation and administrative delegation. Further work might elaborate this claim and explore its relevance beyond drug policy, bringing “scheduling” fully alongside “big waiver,” David J. Barron & Todd D. Rakoff, In Defense of Big Waiver, 113 Colum. L. Rev. 265, 272–91 (2013), as a distinctive tool of regulation. Fourth and most broadly, in highlighting downsides to the current trend away from administrative processes for making drug policy, see infra section III.B.1, pp. 883–87, our project fits within an emerging body of law-and-political-economy scholarship that defends the administrative state after years of mounting attacks, see, e.g., Blake Emerson, The Existential Challenge to the Administrative State, 113 Geo. L.J. 1263, 1306–25 (2025); Gillian E. Metzger, The Supreme Court, 2016 Term — Foreword: 1930s Redux: The Administrative State Under Siege, 131 Harv. L. Rev. 1, 87–91 (2017).

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