Introduction
Professors Matthew Lawrence and David Pozen’s Drug Scheduling as Institutional Design1 is an ambitious and welcome intervention in the long-running debate over U.S. drug policy. The authors reconceptualize the Controlled Substances Act2 (CSA) as a problem of institutional design.3 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.4 Their call for “democratization without domination” in scheduling decisions5 and “legalization without laissez faire” in drug markets6 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.”7 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.8 So too, engagement with the experiences of people who use drugs, including attention to the harmful effects of stigmatizing language,9 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.10 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.11 Scholars in public policy,12 public health,13 history,14 criminology,15 sociology,16 and related fields have examined how institutional arrangements shape drug policy outcomes.17 Along with interdisciplinary legal scholars,18 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.19
Greater engagement with this work would strengthen the Article’s claim to offer a “middle range” theory of drug regulation20 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.21 This orientation is especially appealing in the drug policy context, where moral absolutism and technocratic overconfidence have produced significant harms.22 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;23 deploys criminal, administrative, and civil enforcement mechanisms;24 and encompasses pharmaceutical regulation, health care delivery,25 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.26
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,”27 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 Act28 (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.29 Subject to evolving First Amendment constraints on commercial speech,30 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 actions31 — 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.32 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.33 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;34 the content and form of the drug’s label and labeling;35 required warnings;36 and the imposition of risk evaluation and mitigation strategies (REMS).37 Many controlled substances are subject to REMS,38 which require additional assessments of potential risks and benefits and impose additional conditions, such as practitioner and pharmacy certification and training,39 manufacturer obligations,40 restricted dispensing settings,41 and patient monitoring and tracking.42
Although not without shortcomings, the FDA’s legal requirements and regulatory standards are generally grounded in data-driven scientific criteria.43 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.44 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.45
In fact, the FDA (along with other entities within HHS) has the capacity to address the authors’ concerns around rigid empiricism.46 Unlike the DEA, the FDA already considers less easily quantifiable data — in other words, “real world evidence.”47 The agency has done so under complex conditions, including its consideration of controlled substances.48 Similarly, the FDA and other HHS entities have specifically considered evidence beyond what is required for drug approval, including in scheduling decisions.49 By contrast, the DOJ and the DEA possess comparatively limited scientific and health-focused infrastructure50 — understandably so for institutions designed for law enforcement narrowly focused on market controls, often at the expense of population health and other benefits.51 Yet, despite the breadth of the FDA’s scientific expertise and public health mandate,52 the DEA controls ultimate scheduling determinations.53 This is the principal exception to the FDA’s regulatory authority over drug products,54 and it is consequential, in part, because unlike the DEA, the FDA considers both benefits and harms of drugs55 — including many kinds of evidence that the authors worry go unaddressed and contribute to the pluralism problem.56
We also question whether the health risks of controlled substances are uniquely difficult to evaluate57 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,58 this does not render them insusceptible to systematic evaluation.59 All drugs, controlled and uncontrolled, have effects that vary by person, place, and setting.60 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.61 And the idea that some drugs currently in use are too dangerous to evaluate is unpersuasive as well.62 Of the available options, a health agency is better suited than a law enforcement agency to supervise scheduling. As other scholars have noted,63 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.64 While the authors note that scheduling criteria are “specifie[d] in some detail,”65 they do not fully engage with the system’s irrationality.66 In fact, the current distribution of scheduling authority consistently “produces . . . unscientific scheduling actions that contradict the CSA text, purpose, and history.”67
The process is also self-reinforcing.68 For example, in large part, scheduling decisions depend on the concept of “abuse,”69 but abuse is not defined in the statute or regulations, and its meaning and the weight afforded to it vary widely in practice.70 Two “indicators that a drug . . . has a potential for abuse,” according to the DEA, are (1) “significant diversion . . . from legitimate drug channels” and (2) that “[i]ndividuals are taking the drug . . . on their own initiative rather than on the basis of medical advice.”71 Both are created by scheduling, which constricts access and predictably increases reliance on informal or “illicit” markets, including for therapeutic use. The foreseeable result — that individuals obtain substances without prescriptions or outside regulated supply chains — indicates “abuse” is a self-reinforcing loop justifying continued control, even when use is beneficial.72 Because scheduling incentivizes behavior the DEA considers “abuse,” a scheduled drug is rarely downscheduled or descheduled.73 Upscheduling is far more common and usually privileges law enforcement goals of more control and less access to substances74 — even those with proven benefits.75
And, as the authors note,76 the scheduling framework excludes explicit consideration of benefits, much less any balancing of benefits against harms that might disrupt the cycle. Although there is potential to afford more weight to benefits, that potential is unrealized. Given the irrationality and one-sidedness of scheduling criteria and practices under the final control of the DEA, the idea of adding additional schedules gives us pause — especially in the absence of other significant reforms.
Relatedly, the Article’s account of the joint DEA–HHS scheduling process77 would be strengthened by greater institutional specificity. Although HHS’s scientific and medical recommendations play a critical role,78 they are binding on the DOJ only prior to the initiation of formal rulemaking.79 Thereafter, those recommendations are entitled only to deference.80 This distinction has proved consequential in recent rescheduling debates involving cannabis81 and bears directly on the Article’s claims regarding democratization, expertise, and political accountability. Clarifying these institutional relationships would not dilute the Article’s critique of the current system. Rather, it would sharpen the analysis by demonstrating how authority is distributed — and contested — across agencies, and why institutional design reform must account for that distribution.
The authors propose shifting scheduling authority from the DEA back to the Attorney General.82 In practical terms, this would relocate technical classification decisions from policing personnel to prosecutorial leadership — shifting authority within law enforcement rather than outside it.83 They further characterize the relative political insulation of health agencies as a liability.84 We are unpersuaded.
That argument insufficiently accounts for the long-standing structural project of stigmatizing certain drugs and the people who use — or are perceived to use — them,85 and the degree to which this stigmatization continues to influence public perceptions and political motivations.86 The Attorney General has historically been a central power broker in that project, and the DOJ and DEA occupy leadership roles within the institutional architecture of criminalization that not only establishes a self-justifying feedback loop for the agency,87 but further constructs drugs and drug users as dangerous and deviant, often leveraging existing racial, disability, and other biases in framing and enforcing the CSA.88 In turn, this structure reinforces discriminatory preferences that infect public attitudes and political will.89 These attitudes shape decisionmaking across individual, institutional, and structural domains, fueling harmful — and at times deadly — laws, policies, and practices not only within the criminal legal system but also in health care, housing, employment, and other settings.90 For the foreseeable future, political actors most responsive to public pressure are therefore more likely to reinforce, rather than dismantle, these dynamics. The DEA, in particular, has a pattern and practice of repeating and endorsing many long-standing punitive and stigmatizing approaches.91 For these reasons, we do not believe reallocating authority to the Attorney General offers a meaningful corrective.
Of course, the status quo is likewise unsatisfactory, as the authors persuasively demonstrate. We commend them for looking beyond the binary of DEA versus FDA control.92 Additional institutional configurations warrant consideration, including those suggested by other scholars.93 As one illustration, recent rulemakings jointly issued by the DEA and HHS — or by divisions such as the Substance Abuse and Mental Health Services Administration — have resulted in final regulations reflecting greater attention to benefits and harm reduction than rules promulgated by the DEA alone.94 These processes have also generated substantial public engagement and, in some instances, delayed implementation of enforcement-leaning regulations in ways that have benefited patients who rely on controlled substances for medical care.95 The causal dynamics are complex and extend beyond dual-agency involvement. We offer this example simply as a starting point for the broader institutional inquiry that Lawrence and Pozen have helpfully initiated.
III. Practitioners, Prescribing, and Enforcement Dynamics
The Article’s discussion of practitioners as gatekeepers within the CSA’s regulatory scheme raises related issues where deeper engagement would strengthen the institutional account. Controlled substance prescribing is governed by a dense web of federal and state law, professional regulation, and enforcement practices. There is also a substantial interdisciplinary literature examining how these legal structures shape clinician behavior, patient access, and public health outcomes.
Several points about practitioners merit particular attention. Centering physicians as the primary gatekeepers of the “flow of potentially addictive drugs”96 both overstates their role and lacks important specificity for evaluating institutional design in this context. First, it underestimates the role of the DEA,97 state law enforcement actors,98 and an ecosystem of other gatekeepers (for example, manufacturers, distributors, third-party payors, health care institutions, and state-level cannabis markets) in managing the flow of drugs (both those within and outside of the pharmaceutical market).99 Second, even at the practitioner-patient level, centering physicians ignores the significant role of other institutional forces and individuals in prescribing, dispensing, administering, and filling prescriptions for pharmaceutical controlled substances.100 Two examples are illustrative: (1) pharmacists and pharmacies,101 and (2) third-party payors,102 both of whom can and often do render meaningless the order or prescription by gatekeeping access.
Third, even as restricted to prescribing (or ordering) practitioners,103 it fails to account for the many other practitioners with prescriptive authority and the practice settings for which the DEA’s requirements are far from “ministerial” but instead require multiple registrations, heightened surveillance, tracking, and documentation that disincentivize appropriate care.104 Physicians are but one of many practitioners (in the language of the CSA) authorized to prescribe or dispense controlled substances.105 Physicians, dentists, veterinarians, podiatrists, advanced practice registered nurses (APRNs),106 physician assistants/associates (PAs),107 pharmacists,108 and many others play critical roles,109 often under distinct and more complex regulatory constraints. This is not a matter of minutia — each year, nonphysician practitioners with prescriptive authority occupy a larger slice of the workforce and fill important gaps in access to and quality of care across geographic regions and practice areas,110 including the myriad conditions for which controlled substances are part of everyday standard-of-care practice.111 But the state-level requirements and restrictions that apply to these prescribers are often more stringent and more variable by state than for their physician colleagues.112 Any institutional design proposal that relies on professional gatekeeping would be more persuasive if it explicitly accounted for these differences and for the varied ways in which regulatory pressure is experienced across professional categories.
Fourth, the Article’s suggestion that the DEA plays a limited role in shaping practitioner behavior is difficult to reconcile with enforcement patterns over the past several decades and empirical evidence of practitioner behavior.113 DEA investigations, registrant revocations, and high-profile prosecutions have had a significant chilling effect on prescribing practices, particularly in pain management and addiction treatment.114 Over many decades, the federal government investigated, charged, tried, and convicted prescribers under the CSA’s felony drug distribution provision based on no more, and sometimes less, than a mental state of negligence.115 The mere threat of legal sanction significantly shapes practice behavior and can lead to serious patient harms.116 These enforcement dynamics complicate the Article’s portrayal of medical discretion and underscore the need to integrate criminal enforcement realities into institutional design analysis.
IV. Models of Reform, Layering, and the Meaning of “Fundamental Reassessment”
The Article’s treatment of opioid treatment programs (OTPs) and harm reduction services illustrates the difficulty of using existing institutions as both cautionary examples and affirmative models. OTPs are described in opaque terms, and it is difficult to determine if the authors see them as access barriers, sites of regulatory capture resistant to reform, or otherwise.117 They are, however, used as potential templates for newly proposed schedules permitting nonmedical use under tight controls,118 which is difficult to square with the evidence of harms that have resulted from the overregulation of medical care (OTPs)119 and the overcriminalization of drug use (harm reduction) in this context.120
OTPs operate at the intersection of medicine, criminal law, and administrative oversight, subject to extensive federal and state controls that exceed those applied to most other forms of health care delivery.121 As a result, they provide a vivid example of how a health intervention can be nested within an enforcement-centered framework.122 At the same time, they demonstrate that tightly regulated medicalization does not necessarily displace law enforcement authority; rather, it can institutionalize surveillance, gatekeeping, and access constraints within a clinical setting.123
Taken together, these features complicate the institutional lessons OTPs offer. If OTPs are understood primarily as examples of excessive medicalization, they caution against embedding nonmedical use within highly restrictive clinical regimes. If they are viewed as instances of market capture, they illustrate the risk that specialized regulatory niches may become insulated from broader reform. And, if they are framed as harm reduction operating under severe legal constraints, they underscore how institutional design choices shape who may (and who cannot) access care, under what conditions, and with what degree of state supervision. Clarifying which of these institutional dynamics the Article seeks to replicate — or avoid — would sharpen its use of OTPs as an analogue for new scheduling categories.
The Article appears to draw inspiration from overdose prevention sites and other harm reduction models,124 but using them as a model for Schedule A drugs raises issues of institutional specificity. The few openly operating existing U.S. overdose prevention sites do not function within a federal scheduling framework or a health care delivery model — for example, they do not and cannot dispense federally authorized controlled substances and often operate without licensed medical personnel on site. Instead, they are community-based and grounded in mutual aid. Their operational models differ in significant respects from the tightly medicalized and federally supervised OTP framework.125 Their legal status remains contested, and their operation depends on complex intergovernmental dynamics,126 shaped by federal criminal law, state experimentation, and ongoing litigation.127 Translating such models into a formal federal schedule would fundamentally alter the notion of overdose prevention sites and would require widespread statutory and regulatory changes,128 far beyond creating a special registration category.129 It would also require specification regarding supply chains, liability protections, practitioner involvement, enforcement safe harbors, and coordination among federal, state, and local actors.130 In essence, it would require a separate regulatory scheme akin to but more complicated than the current OTP regulatory framework (with no protections from the probable attendant surveillance structures that undermine the core tenets of harm reduction in the first instance).131
Without clarity on these institutional mechanics, it is difficult to determine whether Schedule A represents structural redesign or an administratively intricate overlay within the existing regime. Any proposal to formalize similar practices within a federal schedule would require careful attention to these institutional differences and the many existing — but unaddressed — regulatory constraints132 on the execution and implementation of Schedule A as described in the Article. Without such clarification, it is difficult to assess whether the Article envisions extending a medicalized gatekeeping model,133 constructing a parallel harm reduction track,134 or developing a distinct governance structure altogether with new forms of market entry, manufacturing, distributing, ordering, administering, and dispensing for certain drugs.
These tensions point to a broader institutional question: whether reform should aim to relax constraints within existing structures, to relocate authority from enforcement agencies to health agencies, or to create genuinely hybrid models that redistribute decision-making power. OTPs and harm reduction programs illuminate the stakes of those choices. They show that institutional form — not merely regulatory category — shapes access, autonomy, oversight, and enforcement exposure. A more explicit engagement with these structural tradeoffs would strengthen the Article’s institutional design analysis and clarify how its proposals would function in practice.
Finally, the Article’s call for a “fundamental reassessment of drug law structures and procedures”135 raises an antecedent question: What, in this domain, counts as structural reform? The proposed creation of additional schedules for nonmedical use reflects a thoughtful and serious effort to move beyond the familiar binary of prohibition and laissez-faire.136 It is not clear, however, that the addition of new schedules necessarily departs from the CSA’s longstanding pattern of institutional layering — addressing perceived shortcomings through carve-outs, parallel regimes, and specialized exceptions while leaving the underlying allocation of authority largely intact.
Drug policy in the United States has historically evolved through recalibration rather than reconstruction.137 As drug governance scholarship has observed, reform frequently proceeds by grafting new regulatory mechanisms onto existing enforcement-centered frameworks rather than displacing them.138 The emergence of opioid treatment programs, research exceptions, risk evaluation and mitigation strategies, and enhanced surveillance systems illustrates this dynamic: Each introduced additional nuance and administrative sophistication, but none fundamentally altered the statute’s core allocation of power between health and law enforcement institutions.139 In this sense, drug policy reform often operates through layering — adding institutional complexity without shifting the system’s center of gravity.140 By most health and equity metrics, this has not been a story of success, at least insofar as success is measured in health, life, and opportunity for people who use drugs.141
The central question, then, is whether the proposed new schedules would constitute transformation in kind or refinement in degree. Structural reassessment would require more than additional regulatory categories; it would entail a meaningful reallocation of authority, a recalibration of evidentiary standards, or a reorientation of default enforcement postures (and likely all three). By “structural reform,” we mean reform that alters the locus of final decisionmaking authority, the governing evidentiary standards, or the institutional default toward enforcement. Institutional layering, by contrast, preserves those foundations while adding new regulatory categories or procedural refinements within them. If final classification authority, enforcement discretion, and core gatekeeping functions remain vested in the same institutions and shaped by the same incentive structures, new schedules may increase regulatory granularity without reconfiguring the institutional architecture itself.
A similar caution applies to the broader reform project. As other scholarship has emphasized, drug governance is shaped not only by statutory design but also by institutional incentives, bureaucratic identity,142 and prevailing “governing images” that frame drugs alternately as crime problems, health issues, or economic goods.143 Reforms that do not address these deeper incentive structures risk being absorbed into existing enforcement logics even when rhetorically framed as health-centered innovation. The history of drug policy demonstrates a persistent capacity to incorporate public health language while preserving enforcement authority — a dynamic that underscores the importance of attending to political economy alongside formal institutional design.144
None of this diminishes the Article’s contribution in reframing scheduling as a question of institutional architecture rather than moral valence.145 To the contrary, it follows directly from the authors’ analytic commitments. If institutional design is the core lens, then “fundamental reassessment”146 must be evaluated in structural terms: who holds decisionmaking authority, under what standards, and subject to which incentives. Clarifying whether the proposed reforms meaningfully redistribute those foundations — or instead refine them — would further strengthen the Article’s institutional account and sharpen its reform agenda.
Conclusion
Drug Scheduling as Institutional Design makes a substantial and important contribution to drug law scholarship. Its institutional framing, analytic clarity, and willingness to engage hard tradeoffs mark it as a significant intervention. The Article’s contributions are most fully realized when read in conversation with interdisciplinary scholarship, with careful attention to agency roles, and with sustained engagement with the legal and clinical realities that shape drug regulation in practice. By foregrounding institutional design, Lawrence and Pozen have opened a conversation that legal scholars, policymakers, and practitioners alike should welcome. Our hope is that this Response contributes to that conversation by highlighting areas where additional grounding and specification can further enhance the Article’s impact — and help move drug policy debates toward more durable, humane, and effective solutions. Institutional design offers a powerful analytic lens — but its promise depends on grounding theory in institutional reality.