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.
Continue Reading in the Full PDF
https://harvardlawreview.org/print/vol-139/drug-scheduling-as-institutional-design/
