Notice & Comment

Symposia

Notice & Comment

Beyond Psychedelics—What Executive Order 14401 Signals for Drug Regulation and Innovation

This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. On April 18, 2026, President Trump issued Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” with the purpose of “increase[ing] access to psychedelic drugs that could save lives and reverse the crisis of […]

Notice & Comment

Super Placebo Psychedelics: How Might FDA Evaluate Blinding Failure?

This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. The expansion of psychedelic medicine has brought neuropsychiatry and pharmaceutical law to a structural, methodological, and institutional crossroads. Federal law requires “substantial evidence of efficacy” (FDA Act §505(d)) and regulations (21 CFR 314.126) mandate that […]

Notice & Comment

Justifying Autonomy Interference via Psychedelic Regulation

This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. Imagine two competent adult patients, each of whom is living with treatment-resistant major depressive disorder (MDD) and struggling with suicidal ideation. Patient A asks her doctor about Pretendazine®, an (imaginary) injectable drug FDA-approved exclusively for […]

Notice & Comment

Law, Discretion, and Psychedelics

This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. Dr. Sunil Aggarwal runs an “integrative oncology clinic” in Seattle, Washington, where he treats patients with late-stage cancer. Some of those patients suffer from the anxiety and depression that often accompany a terminal diagnosis. Aggarwal […]

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Use Cases, Humans in the Loop, and Other Sleights of Hand, by Bridget C.E. Dooling

There are plenty of good use cases for AI in government decisionmaking, but sometimes we need to say no. It seems like it’s harder than it should be right now to say no. AI systems are truly remarkable but they are not capable of making values-laden policy decisions. We kid ourselves if we think that a “human in the loop” is more than an impoverished way to think about what agencies owe the public. We can likely make great progress in regulatory policy by letting algorithms into our loop, not the other way around.

Notice & Comment

Artificial Intelligence and Administrative Law: The UK’s Search for a New Framework, by Joe Tomlinson & Brendan McGurk

This post is the eleventh contribution to Notice & Comment’s symposium on AI and the APA. For other posts in the series, click here. The questions animating this symposium—how administrative law should adapt to the rise of artificial intelligence—are hardly confined to the United States. The United Kingdom, like many other jurisdictions, is grappling with the same […]

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Abdicated Judgment: AI Tools and the Future of Reasoned Decision-Making in Federal Procurement, by Jessica Tillipman

Federal agencies are rapidly expanding their use of artificial intelligence (AI) in government procurement. Much of the public discussion has centered on relatively narrow applications, such as tools that support market research or flag outdated contract clauses. When used to summarize or organize procurement-related information, these tools may pose manageable risks. More complex challenges arise when they extend into discretionary functions, including core evaluative tasks, that federal procurement doctrine presumes a human decision-maker will perform.

Notice & Comment

AI-Empowered Regulatory Reform: Spreading the Virginia Model, by Reeve T. Bull

As these federal efforts get underway, agencies in D.C. can draw on the successes of their counterparts in Richmond. Though federal regulations and state regulations differ in certain important respects, there are substantial similarities. Here are some of the possible components of a federal AI-empowered regulatory modernization initiative.

Notice & Comment

Determining the Reasonableness of Regulating with AI, by Gilbert Orbea & Emily Froude

This post is the fifth contribution to Notice & Comment’s symposium on AI and the APA. For other posts in the series, click here. Among the operative principles of administrative law is the requirement that agencies “examine the relevant data and articulate a satisfactory explanation” for their actions, commonly known as the reasoned decisionmaking requirement. What this […]

Notice & Comment

Do Large Language Models Dream of the Administrative Procedure Act?, by Jack Jones & Burçin Ünel

Nothing in the APA prohibits agencies from using computational tools to gather, synthesize, or even recommend policy choices—and agencies already often rely on modeling tools to inform regulatory standards. What the APA requires is that the final rule itself be the product of reasoned judgment—supported by evidence, responsive to significant comments, and explained in a coherent manner. If those conditions are satisfied on the face of the rule, it is unlikely that a court reviewing a challenge to the rule will examine how AI was used in the decisionmaking process, perhaps absent some external reason to suspect overreliance on AI. If, on the other hand, the rule ignores key evidence, fails to address major concerns or alternatives, or offers inconsistent reasoning, it will be struck down as arbitrary regardless of whether AI was used in its development.

Notice & Comment

Toward Minimum Administrative Law Standards for Agency Usage of AI, by Jordan Ascher & John Lewis

This post is the third contribution to Notice & Comment’s symposium on AI and the APA. For other posts in the series, click here. Much of the emerging thinking about the relationship between administrative law and generative artificial intelligence is premised, expressly or implicitly, on the assumption that AI systems might come to play a leading role […]