Digital Commons Network^™

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Visual Rulemaking, Elizabeth G. Porter, Kathryn A. Watts

Articles

Visual politics are seeping into the technocracy. Rulemaking stakeholders—including agencies, the President, and members of the public—are deploying politically tinged visuals to push their agendas at every stage of high-stakes, often virulently controversial, rulemakings. These images, GIFs, and videos usually do not make it into the official rulemaking record, so this new “visual rulemaking” world has not been discussed much by scholars or others.

In this article, we explore the new visual rulemaking culture that emerged in Obama’s presidency, providing examples and discussing relevant policy implications. Although we recognize some risks, we argue that, on balance, visual rulemaking is a …

Regulating By Example, Susan C. Morse, Leigh Osofsky

Articles

Agency regulations are full of examples. Regulated parties and their advisors parse the examples to develop an understanding of the applicable law and to determine how to conduct their affairs. However, the theoretical literature contains no study of regulatory examples or of how they might be interpreted. Courts differ about whether examples serve as an independent source of law. There is uncertainty about the proper role of this frequently used regulatory tool.

In this Article, we argue that regulatory examples make law. Our claim is that, as a default rule, the legal content offered by regulatory examples is coequal with, …

Pragmatism, Pragtivism, And Private Environmental Governance, Joshua Galperin

Articles

This essay is an edited version of a talk presented at the 2017 J.B. & Maurice C. Shapiro Environmental Law Symposium on Private Environmental Governance at the George Washington University. It is adapted from a longer article entitled Trust Me, I’m A Pragmatist: A Partially Pragmatic Critique of Pragmatic Activism, in 42 Colum. J. Envtl. L. 425 (2017).

Board Rooms And Jail Cells- Assessing Ngo Approaches To Private Environmental Governance, Joshua Galperin

Articles

Staff of the Nature Conservancy often find themselves in corporate board rooms. Staff of Greenpeace often find themselves in jail cells. The Nature Conservancy (TNC) prides itself on its non-confrontational, collaborative deal making, partnering closely with corporations like chemical giant Dow and agricultural lightning rod Monsanto. Both Dow and Monsanto, in fact, are members of TNC’s Business Council along with the likes of BP, Shell, and Cargill. Greenpeace, on the other hand, prides itself on direct action, civil disobedience, and non-violent confrontation. Greenpeace has launched combative operations against Dow, Monsanto, and other TNC collaborators. While business partners praise TNC’s cooperative …

Indeconstructible: The Triumph Of The Environmental “Administrative State”, Stephen M. Johnson

Articles

Shortly after the 2017 Presidential inauguration, a senior advisor to the President proclaimed that a top priority of the Administration would be the “deconstruction of the administrative state.” A primary target of the Administration’s deconstruction efforts was the U.S. Environmental Protection Agency (“EPA”) and federal environmental regulations.

While the President can use a variety of tools, including the appointment power, budget power, treaty power, and executive orders, to influence the manner in which the EPA and other agencies interpret and enforce laws, the President has very little power to unilaterally “deconstruct the administrative state.” The “administrative state” is a creation …