Law Commons^™

Rethinking Innovation At Fda, Rachel Sachs, W. Nicholson Price Ii, Patricia J. Zettler

Scholarship@WashULaw

In several controversial drug approval decisions in recent years, the Food & Drug Administration (FDA) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the agency has come to make many innovation-related judgments as part of …

Examining The Social Security Tribunal’S Navigator Service: Access To Administrative Justice For Marginalized Communities, Laverne Jacobs, Sule Tomkinson

Law Publications

An accessible MS Word version of this document is available for download at the bottom of this screen under "Additional files."

This report provides the findings, analysis and recommendations of a research study conducted on the federal Social Security Tribunal’s Navigator Service (SST Navigator Service). The SST Navigator Service was established in 2019 for tribunal users without a professional representative. The study examines the use of the Navigator Service for Canada Pension Plan–Disability (CPP–Disability) appeals heard by the Income Security - General Division of the Social Security Tribunal.

This research study focuses on access to administrative justice on the …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

All Faculty Scholarship

New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Foreword: Private, Environmental, Governance, Joshua Ulan Galperin

Elisabeth Haub School of Law Faculty Publications

This essay is the invited foreword to the 2017 J.B & Maurice C. Shapiro Environmental Law Symposium issue of the George Washington Journal of Energy and Environmental Law. The 2017 symposium was dedicated to the issue of private environmental governance. This essay recognizes the incredible growth of private environmental governance as an area of study in the legal academy. In addition to introducing the various contributions to the symposium issue, this essay proposes that rather than merely studying "private environmental governance" as an independent concept, scholars should look closely at the individual components, "private," "environmental," and "governance," to better understand …

Stock Market Futurism, Merritt Fox, Gabriel Rauterberg

Articles

The U.S. stock market is undergoing extraordinary upheaval. The approval of the application of the Investors Exchange (IEX) to become the nation's newest stock exchange, including its famous "speed bump," was one of the SEC's most controversial decisions in decades. Other exchanges have proposed a raft of new innovations in its wake. This evolving equity market is a critical piece of national infrastructure, but the regulatory scheme for its institutions is increasingly frayed. In particular, current regulation draws sharp distinctions among different kinds of markets for trading stocks, treating stock exchanges as self-regulatory organizations immune from private civil litigation, while …

Disruptive Platforms, Margot Kaminski

Publications

No abstract provided.

Overreach And Innovation In Equality Regulation, Olatunde C.A. Johnson

Faculty Scholarship

At a time of heightened concern about agency overreach, this Article highlights a less appreciated development in agency equality regulation. Moving beyond traditional bureaucratic forms of regulation, civil rights agencies in recent years have experimented with new forms of regulation to advance inclusion. This new "inclusive regulation" can be described as more open ended, less coercive, and more reliant on rewards, collaboration, flexibility, and interactive assessment than traditional modes of civil rights regulation. This Article examines the power and limits of this new inclusive regulation and suggests a framework for increasing the efficacy of these new modes of regulation.

Standing Voting Instructions: Empowering The Excluded Retail Investor, Jill E. Fisch

All Faculty Scholarship

Despite the increasing importance of shareholder voting, regulators have paid little attention to the rights of retail investors who own approximately 30% of publicly traded companies but who vote less than 30% of their shares. A substantial factor contributing to this low turnout is the antiquated mechanism by which retail investors vote. The federal proxy voting rules place primary responsibility for facilitating retail voting in the hands of custodial brokers who have limited incentives to develop workable procedures, and current regulatory restrictions impede market-based innovation that incorporate technological innovations.

One of the most promising such innovations is standing voting instructions …

Innovation Prizes In Practice And Theory, Michael J. Burstein, Fiona Murray

Faculty Articles

Innovation prizes in reality are significantly different from innovation prizes in theory. The former are familiar from popular accounts of historical prizes like the Longitude Prize: the government offers a set amount for a solution to a known problem, like £20,000 for a method of calculating longitude at sea. The latter are modeled as compensation to inventors in return for donating their inventions to the public domain. Neither the economic literature nor the policy literature that led to the 2010 America COMPETES Reauthorization Act — which made prizes a prominent tool of government innovation policy — provides a satisfying justification …

Optimizing Government For An Optimizing Economy, Cary Coglianese

All Faculty Scholarship

Much entrepreneurial growth in the United States today emanates from technological advances that optimize through contextualization. Innovations as varied as Airbnb and Uber, fintech firms and precision medicine, are transforming major sectors in the economy by customizing goods and services as well as refining matches between available resources and interested buyers. The technological advances that make up the optimizing economy create new challenges for government oversight of the economy. Traditionally, government has overseen economic activity through general regulations that aim to treat all individuals equally; however, in the optimizing economy, business is moving in the direction of greater individualization, not …

Motivating Without Mandates: The Role Of Voluntary Programs In Environmental Governance, Cary Coglianese, Jennifer Nash

All Faculty Scholarship

For the last several decades, governments around the world have tried to use so-called voluntary programs to motivate private firms to act proactively to protect the environment. Unlike conventional environmental regulation, voluntary programs offer businesses flexibility to adopt cost-effective measures to reduce environmental impacts. Rather than prodding firms to act through threats of enforcement, they aim to entice firms to move forward by offering various kinds of positive incentives, ranging from public recognition to limited forms of regulatory relief. Despite the theoretical appeal of voluntary programs, their proper role in government’s environmental toolkit depends on the empirical evidence of how …

Agenda: Innovations In Managing Western Water: New Approaches For Balancing Environmental, Social, And Economic Outcomes, University Of Colorado Boulder. Getches-Wilkinson Center For Natural Resources, Energy, And The Environment

Innovations in Managing Western Water: New Approaches for Balancing Environmental, Social and Economic Outcomes (Martz Summer Conference, June 11-12)

Many aspects of western water allocation and management are the product of independent and uncoordinated actions, several occurring a century or more ago. However, in this modern era of water scarcity, it is increasingly acknowledged that more coordinated and deliberate decision-making is necessary for effectively balancing environmental, social, and economic objectives. In recent years, a variety of forums, processes, and tools have emerged to better manage the connections between regions, sectors, and publics linked by shared water systems. In this event, we explore the cutting edge efforts, the latest points of contention, and the opportunities for further progress.

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Procedural Architecture Matters: Innovation Policy At The Federal Communications Commission, J. Brad Bernthal

Publications

This Article examines the puzzle of whether today's Federal Communications Commission ("FCC" or the "Agency") is institutionally suited to craft telecommunications innovation policy and, if not, what changes are needed to better equip the Agency to respond to twenty-first century realities. Evaluation of FCC innovation policy performance is stubbornly difficult. Some criticize the FCC as a brake on innovation yet, under the FCC's oversight, the United States' communications industry has become an innovative engine propelling the overall economy more than ever before. It is difficult to untangle whether the FCC deserves credit for helping usher in today's communications age, whether …

Slides: Drilling Waste, Blake Scott

Opportunities and Obstacles to Reducing the Environmental Footprint of Natural Gas Development in Uintah Basin (October 14)

Presenter: Blake Scott, Scott Environmental Services, Inc.

24 slides

Agenda: Best Practices For Community And Environmental Protection, University Of Colorado Boulder. Natural Resources Law Center. Intermountain Oil And Gas Bmp Project, Colorado. Oil And Gas Conservation Commission

Best Practices for Community and Environmental Protection (October 14)

The first Intermountain BMP Project workshop, sponsored by the Natural Resources Law Center and the Colorado Oil and Gas Conservation Commission, was held in Rifle, Colorado on October 14, 2009 at the Garfield County Fairground for over 170 participants.

Speakers from Federal, state and local governments, the community, industry and environmental consultants, and conservation groups focused presentations and discussion on a greater understanding of what Best Management Practices (BMPs) are appropriate to the western slope of Colorado and how they are integrated into developments.

Slides: Innovative Best Practices For The Western Slope: Stormwater Management Solutions And Philosophy For The Oil And Gas Industry, Kyle N. Schildt

Best Practices for Community and Environmental Protection (October 14)

Presenter: Kyle N. Schildt, P.E., LT Environmental, Inc.

12 slides

Slides: Bmp Project, Kent Kuster

Best Practices for Community and Environmental Protection (October 14)

Presenter: Kent Kuster, Consultation Coordinator, Colorado Department of Public Health and Environment (CDPHE)

17 slides

Slides: The Roadless Rules And The Roles Of States And Communities, Sharon Friedman

The Future of Natural Resources Law and Policy (Summer Conference, June 6-8)

Presenter: Sharon Friedman, Director of Planning, USDA Forest Service, Rocky Mountain Region

13 slides

Slides: Pinedale Anticline Project Area: The Adaptive Management Process, Prill Mecham

Best Management Practices and Adaptive Management in Oil and Gas Development (May 12-13)

Presenter: Prill Mecham, Pinedale BLM Field Manager

35 slides

Agenda: Innovation In Western Water Law And Management, University Of Colorado Boulder. Natural Resources Law Center

Innovation in Western Water Law and Management (Summer Conference, June 5-7)

Conference organizers and/or faculty included University of Colorado School of Law professors Lawrence J. MacDonnell, David H. Getches, Charles F. Wilkinson and Richard B. Collins.

Pressures of population, drought, and changing water use have provided the impetus for numerous innovations in water law and management in recent years. The Center's annual conference June 5-7, 1991, will look at innovation and change in five areas--water planning, special water management areas, negotiated settlements of tribal water rights, conjunctive use of ground and surface water, and public values in water decision making. Each session will begin with talks by experts from several western …

Agenda: Boundaries And Water: Allocation And Use Of A Shared Resource, University Of Colorado Boulder. Natural Resources Law Center

Boundaries and Water: Allocation and Use of a Shared Resource (Summer Conference, June 5-7)

Conference organizers and/or faculty included University of Colorado School of Law professors David H. Getches, Lawrence J. MacDonnell and Charles F. Wilkinson.

Boundaries and Water: Allocation and Use of a Shared Resource is the topic of the Center's annual summer program on water this June. Most of the major rivers in the western United States are shared between two or more states. Often tribal governments play an important role in water allocation and use decisions. International considerations also may be involved in some cases. These interjurisdictional issues extend to groundwater as well as surface water.

This conference will provide the …