Administrative agencies regulate a wide range of domains: environmental hazards, public health, immigration, national security, and sundry other topics. Yet the law that governs these diverse areas is often said to be “transsubstantive”—that is, in understanding, evaluating, and articulating the rules that govern federal agency action, administrative law lumps these disparate fields together. This one-size-fits-all approach has recently come under attack, but its critics face a challenge: It is one thing to suggest that administrative law should be sensitive to context; it is another to do that in practice. What contexts should administrative law be sensitive to, and will substance-specificity sacrifice the cross-cutting procedural values and considerations that are so central to administrative law?
After introducing the recent critique of transsubstantivity, I will explain one effort that a coauthor and I recently undertook to bridge substance specificity with cross-cutting procedural values and considerations. That project—which became a law review article with Dave Pozen, “Drug Scheduling as Institutional Design“—forced us into applied institutional design, though with a specific focus on substantive drug policy. My hope here is to offer some reflections on how the pragmatic approach we took to applied institutional design—one that centers the problems that make regulation so hard when it comes to addictive drugs—might be useful for doing applied administrative law in other contexts as well.
The Critique of Transsubstantivity
In practice, administrative law has never been context independent. Administration is necessarily focused on real-world problems, and the problems posed by environmental pollution are different than the challenges posed by livestock auctions, which are different than the problems posed by Medicare fraud, and so on. Agencies center the problems specific to their industry while bringing in cross-cutting issues at the margins. Although some statutes, like the Administrative Procedure Act, and some issues, like the challenge of AI comments, cut across regulatory fields, agencies devote the bulk of their attention to the practical realities of their subject matters.
However, in law schools, legal scholarship, and some administrative law doctrine, the story can be different. Rather than centering the substantive problems that agencies confront, administrative law classes and scholarship often foreground cross-cutting statutes and policies (the APA, FOIA, and EO 12866) and broad institutional concerns (capture, efficiency, transparency, presidential control, and so on).
The transsubstantive approach to administrative law is increasingly subject to serious criticism. In 2012, Jerry Mashaw explained that centering cross-cutting laws governing agencies—which tend to be the constraining statutes rather than the enabling ones—contributes to what Nicholas Bagley would call a “procedure fetish.” As Mashaw wrote, “in our world of multiple transsubstantive statutes and ubiquitous judicial review, we tend to think of our administrative constitution as a set of external constraints upon agencies.” Picking up this theme, Peter Strauss explained that transsubstantivity forces students to “encounter . . . agencies through the eyes of the possibly censorious, and inevitably retrospective and incidental-litigation-oriented courts.”
More recent critiques of transsubstantivity have noted additional problems. Sanne Knudsen traces courts’ “puzzling disregard for laws meant to enhance quality of life and human survival” to the transsubstantive “nature of administrative law.” In a forthcoming edited volume, three separate chapters—one by Ganesh Sitaraman (on “the Mission State”), another by Noah Rosenblum & Lev Menand (“The Case for Administrative Law Pluralism”), and my own (“Antifragile Administrative Law”)—note a litany of additional problems with transsubstantivity that I will not try to repeat here (you’ll have to read the chapters!).
For a flavor of the case, however, consider a workforce and capacity argument that I make in my own critique: transsubstantive administrative law courses and scholarship create a fertile intellectual environment for attacks on the administrative state and skepticism about its benefits, because the “costs” of administration (arbitrariness, capture, etc.) are visible at a transsubstantive level but the benefits (things like better health and cleaner air) are visible only at the level of particular agencies and programs.
It is one thing to critique transsubstantivity, however, and another to supplement it or even replace it. There are, indeed, cross-cutting issues and cross-cutting laws and policies that most or all agencies face. If we shift to centering substantive issues rather than transsubstantive ones, would we simply trade the downsides of one-size-fits-all approaches that shoehorn in substance for the downsides of substance-specific approaches that shoehorn in cross-cutting issues? And would we wind up focusing on “real world” goals like better health or environmental protection (a good thing) but forgetting about important process values like accountability, nonarbitrariness, and antisubordination?
A Pragmatic Approach
To bridge cross-cutting insights about institutional design into agency-specific contexts, we should adopt a pragmatic approach. Pragmatism focuses on “what works,” emphasizing problem identification, the use of diverse sources of evidence, and dynamic ongoing reassessment. In a recent article, David Pozen and I employed this approach to analyze drug scheduling, and we found it particularly useful to examine how regulation operates in practice and identify problems that require contextually tailored institutional design.
Some necessary background: the Controlled Substances Act creates five “schedules” of regulatory controls for psychoactive substances, specifies the factors that the Department of Justice must consider when determining whether to place a drug on a schedule, and prescribes the procedures—including formal rulemaking and HHS consultation—that the Department of Justice must follow in making those determinations. U.S. drug policy under this framework has, by most measures (including mortality, mass incarceration, and access barriers), been unsuccessful during the more than fifty years since its enactment. We therefore focused on understanding how the CSA administrative framework has contributed to this failure and how it might be reformed to yield better results in the future.
Addictive drugs are hard to regulate for three reasons: the prohibition problem (inelasticity of demand due to addiction means that bans often backfire), the pharma problem (manufacturers of addictive products have super-charged incentives to manipulate consumers, science, and policy processes), and the pluralism problem (while decisions about drug regulation must be informed by expertise, they often ultimately require political judgments).
Centering the complications that arise in regulating addictive drugs helps answer questions about the drug scheduling system that neither a transsubstantive approach nor a pure drug policy lens (which might focus on access, equity, and harm reduction) could do alone. For example, this framework helped reveal that the existing scheduling system blends legislative direction with administrative discretion. Congress articulates drug-agnostic packages of control, factors, and processes, and the agency is charged with making judgments about scheduling for specific drugs and elaborating on Congress’ regulatory packages and factors.
Existing policy proposals would depart from this blend of legislative direction with regulatory discretion. Under some proposals, Congress directly legislates regulatory approaches for particular drugs—as it does for tobacco. One can also imagine the possibility of letting agencies regulate drugs subject to a broad “public interest” delegation. However, these approaches forfeit a key benefit of the current scheduling system, which heightens the salience and public understanding of drug policy choices, thereby both mitigating industry influence and facilitating public political engagement. In short, the current scheduling system’s blend of legislative direction and regulatory discretion mitigates the pharma problem without creating a pluralism problem.
This pragmatic approach yields lessons that might generalize to administration in other domains. A robust literature studies the pros and cons of “waivers,” which combine a regulatory default with the possibility of agency divergence. Drug scheduling offers a different but analogous model—a legislatively set menu with decision criteria to guide agency decision-making in practice among the menu of choices set by Congress. This institutional design approach may be valuable in other contexts that also combine a heightened risk of industry capture with an inevitable need for political judgments that precludes resort to independent experts to prevent such manipulation.
How Generalizable?
I do not mean to suggest that Pozen and I are the first or only scholars to use a pragmatic focus on the problems that make regulation in a particular domain difficult as a way to bridge cross-cutting institutional design insights into that domain. Nor do I think our approach necessarily generalizes to other fields and contexts. Our focus was on addressing drug scheduling, not fixing the analytical technologies of administrative law. Indeed, if I had a clearer sense of the lessons of our effort for that more abstract question, I would be writing an essay or article fully elaborating the argument, not a blog post! But I do hope these reflections and the drug scheduling example are useful to others thinking about whether and how to do administrative law after transsubstantivity. Perhaps other administrative law domains come with distinctive challenges of their own that ought to be identified and distinguished to inform applied institutional design.
