Response To:
Introduction
Professors Matthew Lawrence and David Pozen’s Drug Scheduling as Institutional Design is an ambitious and welcome intervention in the long-running debate over U.S. drug policy. The authors reconceptualize the Controlled Substances Act (CSA) as a problem of institutional design. This shift in analytic frame is timely and valuable. It invites scholars and policymakers to ask not merely where and how American drug law and policy have failed, but why its governing structures have proven persistently unable to successfully manage the complex, recurring tradeoffs inherent in regulating controlled substances.
The Article’s core contribution lies in its effort to synthesize public law theory, administrative design, and contemporary drug policy reform into a single account. The authors’ identification of three persistent obstacles — the prohibition problem, the pharma problem, and the pluralism problem — offers a useful vocabulary for understanding why drug regulation has resisted durable solutions despite decades of reform efforts. Their call for “democratization without domination” in scheduling decisions and “legalization without laissez faire” in drug markets is an important corrective to reform movements that oscillate between punitive prohibition and unregulated commercialization.
This Response proceeds in a spirit of engagement rather than opposition. Lawrence and Pozen are to be commended for their scholarly framing. We share the authors’ view that the CSA’s failures cannot be explained solely by moral panics, bad science, punitive intent, or political opportunism, and that institutional design deserves far more sustained attention than it has historically received. At the same time, the Article’s proposed scheduling interventions invite deeper consideration of multifactorial realities that shape drug regulation and resulting practices on the ground. Workable pragmatic reform, as the authors note, is “problem-oriented [and] context-sensitive.” It requires a comprehensive understanding of downstream realities and the experiences of those most affected.
Engagement with existing interdisciplinary scholarship on clinical care under federal drug control regimes is warranted. This includes scholarship on pharmaceutical regulation; practitioner regulation (including prescribing, ordering, dispensing, and administering practitioners and entities); the segregated, triple-regulated federal regime governing opioid use disorder treatment; and clinical care more broadly. So too, engagement with the experiences of people who use drugs, including attention to the harmful effects of stigmatizing language, would enrich any such reform. A more robust exploration of harm reduction and agency authority in these contexts could further sharpen the focus on the institutional dynamics that bear on the persuasiveness of the authors’ reform proposals.
Our aim here is not to contest the Article’s central framework. Rather, we seek to identify several context-dependent areas that bear on the ultimate success of the suggested reforms and the Article’s institutional account — especially for readers less familiar with the operational details at the intersection of drug law and health regulation. The Parts that follow elaborate these considerations.
Part I situates the Article’s institutional design framework within a broader interdisciplinary literature and examines the demands that a pragmatic institutional approach imposes, emphasizing the need for grounding in the operational complexity of contemporary drug regulation. Part II clarifies the distribution of authority among federal agencies and why those allocations matter for scheduling reform. Part III turns to practitioners and enforcement dynamics, exploring how prescribing regulation and criminal enforcement shape the institutional environment in which reform would operate. Part IV considers opioid treatment programs and harm reduction as institutional case studies, particularly regarding proposed Schedule A, and Part V assesses whether the Article’s proposed reforms constitute structural redesign or incremental layering within the CSA framework.
I. Institutional Design as a Frame and the Demands of Pragmatism
The Article’s reconceptualization of drug policy as a failure of institutional design is both productive and overdue. By treating the CSA as a governance architecture rather than just a classificatory regime, Lawrence and Pozen help shift the conversation away from substance-specific debates and toward structural questions about authority, accountability, and regulatory capacity. This move is particularly valuable in a policy domain where repeated reform efforts often focus on correcting individual scheduling decisions without interrogating the institutional machinery that produces them. Lawrence and Pozen’s approach is admirable. At the same time, additional institutional dynamics complicate their conclusions and deserve sustained attention, including the operational realities in areas such as prescribing regulation, harm reduction, and pharmaceutical oversight. This would clarify how the Article’s institutional design proposals would interact with entrenched systems rather than sit alongside them in abstraction.
The institutional design lens has a longer and broader lineage than the Article’s framing sometimes suggests. Scholars in public policy, public health, history, criminology, sociology, and related fields have examined how institutional arrangements shape drug policy outcomes. Along with interdisciplinary legal scholars, this work interrogates the CSA’s scheduling framework as an institutional mechanism rather than a neutral scientific taxonomy and the interactions between enforcement dynamics, professional regulation, prescribing law, reimbursement structures, and public health interventions. Admittedly, many of these scholars have not used the “institutional design” or institutionalism label, but have nonetheless explored precisely the kinds of questions the Article raises: how regulatory authority is allocated, how agencies interact, and how institutional incentives shape behavior across markets and professions.
Greater engagement with this work would strengthen the Article’s claim to offer a “middle range” theory of drug regulation by situating it within an already robust, if fragmented, body of institutional analysis. Recognizing this broader scholarly landscape would not diminish the Article’s originality. Instead, it would underscore the distinctive contribution that public law analysis brings to an interdisciplinary conversation that has often proceeded without sustained engagement from constitutional and administrative law scholars.
Additionally, the authors describe their approach as pragmatic, emphasizing practicality, pluralism, and empirically informed experimentation over abstract principles. This orientation is especially appealing in the drug policy context, where moral absolutism and technocratic overconfidence have produced significant harms. The Article’s resistance to both prohibitionist idealism and deregulatory fatalism is among its most important contributions.
Pragmatism, however, imposes demanding obligations on institutional analysis. It demands attention not only to normative coherence but also to implementation pathways, bureaucratic incentives, and political durability. Reform proposals must be evaluated not only for conceptual coherence, but also for how they would operate within the existing legal, clinical, and political landscape. That landscape spans federal, state, and even local law; deploys criminal, administrative, and civil enforcement mechanisms; and encompasses pharmaceutical regulation, health care delivery, professional oversight, consumer protection, and public health promotion. These overlapping domains are further shaped by market incentives, enforcement cultures, and social norms that vary widely across substances and settings.
Because the Article seeks to address these domains simultaneously, it necessarily moves quickly across them, at times leaving key institutional dynamics underdeveloped. This is not a critique of ambition — indeed, the project’s breadth is one of its strengths. But some of the proposed reforms would be more persuasive if the analysis more precisely drew on existing research and practice to demonstrate concretely how existing and proposed regulatory structures function.
II. Agency Roles and the Architecture of Drug Regulation
“Effective institutional design requires an understanding of how bureaucracies operate and why they act,” and additional specificity in several interagency dynamics is useful in considering Lawrence and Pozen’s institutional design lens. First, drug regulation reaches beyond scheduling, and substantial regulatory authority over both scheduled and unscheduled substances resides outside the Drug Enforcement Agency (DEA). Additional attention to the respective roles of the DEA, the DOJ, Health and Human Services (HHS), the FDA, and the FTC would significantly bolster the Article’s institutional analysis. Second, while the Article appropriately centers the CSA’s scheduling regime and the DEA’s authority within it, the degree and scope of the DEA’s expertise is overstated, and the extent to which scheduling criteria diverge from established scientific standards is understated. Third, greater precision is warranted in describing the joint DEA–HHS scheduling process, which bears directly on the Article’s claims about democratization, expertise, and political accountability. Clarifying how authority is allocated — and contested — across agencies would not weaken the Article’s critique. Instead, it would sharpen the institutional account by situating reform proposals within the actual architecture of interagency power.
A. Overlapping Federal Authority and the Centrality of the FDA
The FDA plays the primary regulatory role in drug approval, labeling, marketing, and post-market surveillance in enforcing the Federal Food, Drug, and Cosmetic Act (FDCA). Its authority extends to many (if not most) of the market practices that the Article seeks to regulate more aggressively, including advertising and detailing by pharmaceutical manufacturers. In that area, the FDA shares authority with the FTC, which exercises consumer protection and competition authority relevant to drug markets, including deceptive marketing and unfair trade practices. Subject to evolving First Amendment constraints on commercial speech, the FDA — together with the FTC — are institutionally better positioned to address the pharmaceutical marketing dynamics at the core of the pharma problem. A more sustained engagement with these agencies’ existing powers — and with the administrative and constitutional law governing their actions — would clarify the promise and the limits of the Article’s proposed reforms, especially in addressing the pharma problem.
The FDA likewise shares authority with the DEA over pharmaceutical products that are controlled substances. The FDA determines — subject to established safety and effectiveness standards and ongoing post-market review — whether such products enter or remain on the market and under what conditions. In exercising that authority, the FDA establishes the scientific criteria for and conditions of continued approval. These include whether a drug is limited to “prescription only” status; the content and form of the drug’s label and labeling; required warnings; and the imposition of risk evaluation and mitigation strategies (REMS). Many controlled substances are subject to REMS, which require additional assessments of potential risks and benefits and impose additional conditions, such as practitioner and pharmacy certification and training, manufacturer obligations, restricted dispensing settings, and patient monitoring and tracking.
Although not without shortcomings, the FDA’s legal requirements and regulatory standards are generally grounded in data-driven scientific criteria. The agency is staffed by highly credentialed scientific and medical experts — which the Article may be too quick to characterize as too insulated from practical experience to address the pluralism problem. Particularly in the context of controlled substances policy, some isolation from the effects of entrenched structural discrimination against people who use drugs might be beneficial — especially when combined with expertise in considering many kinds of evidence.
In fact, the FDA (along with other entities within HHS) has the capacity to address the authors’ concerns around rigid empiricism. Unlike the DEA, the FDA already considers less easily quantifiable data — in other words, “real world evidence.” The agency has done so under complex conditions, including its consideration of controlled substances. Similarly, the FDA and other HHS entities have specifically considered evidence beyond what is required for drug approval, including in scheduling decisions. By contrast, the DOJ and the DEA possess comparatively limited scientific and health-focused infrastructure — understandably so for institutions designed for law enforcement narrowly focused on market controls, often at the expense of population health and other benefits. Yet, despite the breadth of the FDA’s scientific expertise and public health mandate, the DEA controls ultimate scheduling determinations. This is the principal exception to the FDA’s regulatory authority over drug products, and it is consequential, in part, because unlike the DEA, the FDA considers both benefits and harms of drugs — including many kinds of evidence that the authors worry go unaddressed and contribute to the pluralism problem.
We also question whether the health risks of controlled substances are uniquely difficult to evaluate or whether such a suggestion is merely another form of drug exceptionalism. While some drugs, especially botanicals and drugs not legally manufactured, have variable effects, this does not render them insusceptible to systematic evaluation. All drugs, controlled and uncontrolled, have effects that vary by person, place, and setting. That psychedelics, for example, have a broad range of variability, does not make their effects impenetrable by the FDA — in fact, the FDA has provided express guidance on this issue. And the idea that some drugs currently in use are too dangerous to evaluate is unpersuasive as well. Of the available options, a health agency is better suited than a law enforcement agency to supervise scheduling. As other scholars have noted, there are compelling reasons to consider expanding — rather than diminishing — the FDA’s role in this domain, including its institutional orientation toward comprehensive evaluations and health-risk assessments.
B. Irrational Scheduling System and Processes
While health agencies are well equipped to evaluate drug benefits and risks, the scheduling criteria themselves are so problematic that any scheduling authority may struggle to make sense of them without institutional reform to those criteria. While the authors note that scheduling criteria are “specifie[d] in some detail,” they do not fully engage with the system’s irrationality. In fact, the current distribution of scheduling authority consistently “produces . . . unscientific scheduling actions that contradict the CSA text, purpose, and history.”
Read the full article