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. …

Unplanned Obsolescence: Interpreting The Automatic Telephone Dialing System After The Smartphone Epoch, Walter Allison

Michigan Law Review

Technology regulations succeed or fail based upon their ability to regulate an idea. Constant innovation forces legislators to draft statutes aimed at prohibiting the idea of a device, rather than a specific device itself, because new devices with new capacities emerge every day. The Telephone Consumer Protection Act (TCPA) is a federal statute that imposes liability based on the idea of an automatic telephone dialing system (ATDS). But the statute’s definition of the device is ambiguous. The FCC struggles to coherently apply the definition to new technologies, and courts interpret the definition inconsistently. Federal circuit courts have split over these …

The International Intellectual Property Commercialization Council’S 3rd Annual U.S. Conference: The State Of Innovation In The Union, Jeffery P. Langer, Neel Sukhatme, Paul R. Zielinski, G. Nagesh Rao, Pj Bellomo, Matthew Byers, Meghan Gaffney Buck, Everardo Ruiz, Andrei Iancu, Patrick Kilbride, Carl J. Schramm, Colman Ragan, Ami Patel Shah, Randall R. Rader

Catholic University Journal of Law and Technology

The International Intellectual Property Commercialization Council (“IIPCC”) presented its third annual policy conference at the United States Capitol on May 6, 2019. The conference’s theme explored the question of “what is the state of innovation in the United States?” Panelists included The Honorable Andrei Iancu – Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office; Dr. Carl J. Schramm – University Professor, Syracuse University and Former President of the Ewing Marion Kauffman Foundation; Mr. Patrick Kilbride – Senior Vice President of the Global Innovation Policy Center (“GIPC”) at the U.S. Chamber of …

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 …

‘Airbnb’ In Western Australia: New Issues For Policy Makers Arising From A ‘Disruptive Innovatation', Bertus De Villiers

The University of Notre Dame Australia Law Review

The short terms rental market, colloquially referred to as ‘Airbnb’ accommodation, has proliferated the Australian (and international) accommodation market. The number of rooms being made available per nights in Australia via sort term rental websites runs into the hundreds of thousands. Policy makers have generally been slow to respond to this ‘disruptive innovation’. It is particularly in strata title schemes where the legality of short term rentals is being tested. In this article consideration is given to a recent judgement of the Supreme Court of Appeal in Western Australia to uphold a decision of the State Administrative Tribunal whereby a …

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah

Michigan Telecommunications & Technology Law Review

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …

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 …

Disrupting Immigration: How Administrative Rulemaking Could Transform The Landscape For Immigrant Entrepreneurs, Tess Douglas

Pepperdine Law Review

Immigrant entrepreneurs come to the United States and start thriving companies that create jobs, drive the economy, and facilitate innovation. However, U.S. laws do not provide a clear path for immigrant entrepreneurs to lawfully enter and work in America. Therefore, immigrant entrepreneurs must seek lawful status in the United States through unusual routes. While Congress, the President, and the United States Citizenship and Immigration Services (USCIS) recognize the need for clear and accessible immigration standards for immigrant entrepreneurs, the politicized nature of immigration law has impeded significant change. This Comment details how administrative rules could offer a less politicized and …

Disruptive Platforms, Margot Kaminski

Publications

No abstract provided.

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 …

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.

Economic Solutions To Nuclear Energy's Financial Challenges, Zachary Robock

Michigan Journal of Environmental & Administrative Law

This Note presents a legal, economic, and regulatory roadmap to drive long-term innovation in sustainable energy generation. Next-generation nuclear power, which fundamentally mitigates many safety and nuclear waste issues, is the focus of this Note; however, the economic concepts can be applied to encourage solar, wind, advanced battery, and other sustainable technologies with high upfront costs and low long-term variable costs. Advanced nuclear energy generation is economically competitive on a long-term levelized cost basis, but suffers from a timing issue—a large amount of capital is needed upfront, with repayment over several decades, during which time significant capital costs can accrue …

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

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 …

Arctic Justice: Addressing Persistent Organic Pollutants, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This article recommends enhanced governance of persistent organic pollutants through incentives to develop environmentally sound, climate friendly technologies as well as caution in developing the Arctic. It highlights the toxicity challenges presented by POPs to Arctic people and ecosystems.

Innovation Cooperation: Energy Biosciences And Law, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This Article analyzes the development and dissemination of environmentally sound technologies that can address climate change. Climate change poses catastrophic health and security risks on a global scale. Universities, individual innovators, private firms, civil society, governments, and the United Nations can unite in the common goal to address climate change. This Article recommends means by which legal, scientific, engineering, and a host of other public and private actors can bring environmentally sound innovation into widespread use to achieve sustainable development. In particular, universities can facilitate this collaboration by fostering global innovation and diffusion networks.

Energy Revolution And Disaster Response In The Face Of Climate Change, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

Nuclear meltdown in Japan and civil society strife across the Middle East highlight the degree to which resilience is core to international peace and security. This article considers the means by which communities can become increasingly resilient through shared best practices across a range of climate change measures.

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

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Michigan Telecommunications & Technology Law Review

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …