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Articles 1 - 22 of 22
Full-Text Articles in Law
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Michigan Telecommunications & Technology Law Review
Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
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 …
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
High-Frequency Trading: Should Regulators Do More, Matt Prewitt
High-Frequency Trading: Should Regulators Do More, Matt Prewitt
Michigan Telecommunications & Technology Law Review
High-Frequency Trading ("HFT") is a diverse set of algorithmic trading strategies characterized by fast order execution. Its importance in international markets has increased vastly in recent years. From a regulatory perspective, HFT presents difficult and partially unresolved questions. The difficulties stem partly from the fact that HFT encompasses a wide range of trading strategies, and partly from a dearth of unambiguous empirical findings about HFT's effects on markets. Yet certain important conclusions are broadly accepted. HFT can increase systemic risk by causing or exacerbating events like the "Flash Crash" of May 6, 2010. HFT can also enable market manipulators to …
Viewer Discretion Is Advised: Disconnects Between The Marketplace Of Ideas And Social Media Used To Communicate Information During Emergencies And Public Health Crises, Peter Maggiore
Michigan Telecommunications & Technology Law Review
In a sense, social media has become the ideal manifestation of the "Marketplace of Ideas" (hereinafter "Marketplace") that Chief Justice Oliver Wendell Holmes articulated. The Marketplace concept will be discussed in greater detail below, but in brief, it is the theory that truth will surface over falsehoods when all opinions and ideas are freely expressed, because the value or worth of that opinion or idea will be determined on the market of public opinion. Part I of this Note will examine the Marketplace concept through the works of various legal and philosophical theorists. Chief among them is Frederick Schauer's work …
Toward Legitimacy Through Collaborative Governance: An Analysis Of The Effect Of South Carolina's Office Of Regulatory Staff On Public Utility Regulation, William H. Ellerbe
Toward Legitimacy Through Collaborative Governance: An Analysis Of The Effect Of South Carolina's Office Of Regulatory Staff On Public Utility Regulation, William H. Ellerbe
Michigan Telecommunications & Technology Law Review
In 2004 the South Carolina General Assembly instituted a major reform to its system of public utility regulation. Previously, the Public Service Commission, the administrative agency in charge of regulating public utilities, both adjudicated utility proceedings and, through its staff,a advocated for the public interest. A scandal concerning revelations of extensive ex parte communications between regulated utilities and members of the Public Service Commission led to the 2004 reform, which created the Office of Regulatory Staff (ORS) as a separate agency to perform the Commission's advocative functions. In my research, I use data on fuel factor proceedings before and after …
Does Law Matter Online - Empirical Evidence On Privacy Law Compliance, Michael Birnhack, Niva Elkin-Koren
Does Law Matter Online - Empirical Evidence On Privacy Law Compliance, Michael Birnhack, Niva Elkin-Koren
Michigan Telecommunications & Technology Law Review
Does law matter in the information environment? What can we learn from the experience of applying a particular legal regime to the online environment? Informational privacy (or to use the European term, data protection) provides an excellent illustration of the challenges faced by regulators who seek to secure user rights and shape online behavior. A comprehensive study of Israeli website compliance with information privacy regulation in 2003 and 2006 provides insights for understanding these challenges. The study examined the information privacy practices of 1360 active websites, determining the extent to which these sites comply with applicable legal requirements related to …
Wireless Net Neutrality Regulation And The Problem With Pricing: An Empirical, Cautionary Tale, Babette E.L. Boliek
Wireless Net Neutrality Regulation And The Problem With Pricing: An Empirical, Cautionary Tale, Babette E.L. Boliek
Michigan Telecommunications & Technology Law Review
I present here a unique empirical analysis of the consumer welfare benefits of prior regulation in the mobile telecommunications industry. In particular, I analyze the relative consumer benefits of state rate regulation and federal entry regulation. The institution of filing requirements and FTC review and approval of various consumer pricing regimes is highly analogous to the consumer price controls imposed by various state level public utility commissions in the past. Furthermore, the imposition of a zero-price rule is analogous to past rate regulation; in particular it is similar to past wholesale regulation with its underlying principles of open access and …
Regulating Robocalls: Are Automated Calls The Sound Of, Or A Threat To, Democracy, Jason C. Miller
Regulating Robocalls: Are Automated Calls The Sound Of, Or A Threat To, Democracy, Jason C. Miller
Michigan Telecommunications & Technology Law Review
African-American voters receive a phone message implying that they are not registered to vote. Others hear "an almost threatening male voice," a "fake New York accent," factual distortions about legislation, false endorsements from controversial groups, calls promoting one candidate claiming to be from his opponent, and a constant barrage of annoying phone calls designed to make voters think a different candidate was sponsoring them. These messages were delivered through automated political telephone calls, also known as robocalls. Robocalls are cheap and efficient--one can deliver a pre-recorded message through 100,000 automated phone calls in one hour for only $2000. Consequently, robocalls …
The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang
The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang
Michigan Telecommunications & Technology Law Review
China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to be met …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
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 …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …
A Shadow Government: Private Regulation, Free Speech, And Lessons From The Sinclair Blogstorm, Marvin Ammori
A Shadow Government: Private Regulation, Free Speech, And Lessons From The Sinclair Blogstorm, Marvin Ammori
Michigan Telecommunications & Technology Law Review
Because of the economics of online information, thousands who do not know each other can band together in hours, without previous organizational coordination or any persistent central coordination, to affect others and conform society to their idea of the social good. This changes the dynamic of political action and the ability of unaffiliated, lone individuals to respond to social acts where government and the market have not. Through ad hoc volunteerism, the Sinclair participants produced regulatory action against a private party with whom they were not transacting--because they believed government failed to do so. Although ad hoc volunteerism has received …
Technology Wars: The Failure Of Democratic Discourse, Gregory N. Mandel
Technology Wars: The Failure Of Democratic Discourse, Gregory N. Mandel
Michigan Telecommunications & Technology Law Review
Conflicts over the use and regulation of various technologies pervade public discourse and have dramatic implications for the public interest. Controversies over the regulation of genetically modified products, nuclear power, and nanotechnology, among others, provoke some of the most socially and politically volatile debates of our time. These technology conflicts extract a substantial price from society--they create costly inefficiencies, prevent society from optimally managing new technologies, consume vast resources, and retard technological growth. This Article develops a framework for understanding technology controversies, and consequently proposes new means for resolving or ameliorating a variety of seemingly intractable legal and regulatory standoffs. …
Application Of The Public-Trust Doctrine And Principles Of Natural Resource Management To Electromagnetic Spectrum, Patrick S. Ryan
Application Of The Public-Trust Doctrine And Principles Of Natural Resource Management To Electromagnetic Spectrum, Patrick S. Ryan
Michigan Telecommunications & Technology Law Review
The Electromagnetic spectrum is among our most valuable natural resources. Yet while the past few decades have seen a rich body of environmental law develop for other natural resources, this movement has largely passed over the electromagnetic spectrum. This Article argues that to remedy that situation, the public-trust doctrine, which is now a cornerstone of modern environmental law, should be extended to the electromagnetic spectrum. This extension would not be a leap: the public-trust doctrine has already been used to guarantee the public access to various bodies of water (not just navigable water), and to protect recreational lakes and beaches, …
Regulating Speech Across Borders: Technology Vs. Values, Matthew Fagin
Regulating Speech Across Borders: Technology Vs. Values, Matthew Fagin
Michigan Telecommunications & Technology Law Review
The disfavored status within international law of unilateral state-based regulations that target extraterritorial actors arises from the inherent challenges such actions represent to state sovereignty. In the context of the Internet, the complexity of choice-of-law analysis is heightened: regulations imposed by one state have the potential to effectively block communications to citizens of all states and undermine the conflicting regulatory aims of neighboring states. Early legal commentators built upon this cascading chilling effect of state-based regulation to proclaim both the futility and illegitimacy of state-based action in the online environment. Subsequent scholars have demonstrated the commensurability of state-based online regulation …
Telemedicine: Rx For The Future Of Health Care, Susan E. Volkert
Telemedicine: Rx For The Future Of Health Care, Susan E. Volkert
Michigan Telecommunications & Technology Law Review
Quite simply, telemedicine symbolizes and catalyzes the clash between the reality of our legal and political approach to health care and the American dream of bringing health care to all patients. Telemedicine, like our health care delivery systems, is regulated by many layers of government. Unlike other issues, telemedicine cuts through and challenges the traditional controls of access and cost. As such, telemedicine is a microcosm of our health care delivery system and a lens through which one may analyze the obstacles to access in the current system. This article examines these issues, proposes that telemedicine's goal should be to …
Schizophrenia Among Carriers: How Common And Private Carriers Trade Places, Rob Frieden
Schizophrenia Among Carriers: How Common And Private Carriers Trade Places, Rob Frieden
Michigan Telecommunications & Technology Law Review
This article will examine court cases and actions by the Federal Communications Commission (FCC) that distort the traditional concepts of common and private carriage by establishing new rights and responsibilities previously applicable to the other category of carrier. This article will also consider the feasibility of (a) maintaining the traditional common carrier regulatory model and (b) continuing the application of that model to basic services provided by local exchange carriers (LECs). This is especially important as LECs qualify to become private carriers tapping new market opportunities, even within the same geographical region where they provide basic services. Finally, this article …
The Information Highway Must Pay Its Way Through Cities: A Discussion Of The Authority Of State And Local Governments To Be Compensated For The Use Of Public Rights-Of-Way, Clarence A. West
Michigan Telecommunications & Technology Law Review
In the ever-changing telecommunications industry there appears to be an enormous amount of confusion not only as to the appropriate amount of compensation chargeable to the users of public rights-of-way, but also as to the very authority of state and local governments to require compensation. This was not always the case. It has long been a well-settled legal principle that local governments may receive reasonable "rental" compensation from private commercial entities for their use of local public property for private economic gain, even where federal statutory law restricts local governments from denying access to rights-of-way for telecommunications services. For example, …
Telecommunications In Transition: Unbundling, Reintegration, And Competition, David J. Teece
Telecommunications In Transition: Unbundling, Reintegration, And Competition, David J. Teece
Michigan Telecommunications & Technology Law Review
The world economy is experiencing a technological revolution, fueled by rapid advances in microelectronics, optics, and computer science, that in the 1990s and beyond will dramatically change the way people everywhere communicate, learn, and access information and entertainment. This technological revolution has been underway for about a decade. The emergence of a fully-interactive communications network, sometimes referred to as the "Information Superhighway," is now upon us. This highway, made possible by fiber optics and the convergence of several different technologies, is capable of delivering a plethora of new interactive entertainment, informational, and instructional services that are powerful and user-friendly. The …
Turner Broadcasting, The First Amendment , And The New Electronic Delivery Systems, Henry Geller
Turner Broadcasting, The First Amendment , And The New Electronic Delivery Systems, Henry Geller
Michigan Telecommunications & Technology Law Review
After ducking the issue of the First Amendment status of cable television for years, the United States Supreme Court rendered its most important decision concerning the regulation of the new electronic media in Turner Broadcasting, Inc. v. FCC. Turner involved the constitutionality of the "must-carry" provisions of the 1992 Cable Act (the "Act" or "Cable Act") which require cable systems to carry specified local broadcast television stations. While cable television began over four decades ago as a community antenna service, it changed drastically after the advent of satellite in the mid-1970's to also provide scores of satellite-delivered programs and to …
Unconstitutional Telco-Cable Cross-Ownership Ban: It Seemed Like A Good Idea At The Time, Arthur Bresnahan
Unconstitutional Telco-Cable Cross-Ownership Ban: It Seemed Like A Good Idea At The Time, Arthur Bresnahan
Michigan Telecommunications & Technology Law Review
This article is a survey of the law regarding the federal government's ability to regulate a telephone company's provision of video programming to subscribers in its service area. Part I of the article is a history of the telco-cable cross-ownership ban. Part II is an analysis of the cases striking down the ban, exploring the rationale of these cases on a consolidated basis. Part III is a summary of the applicable standards by which to evaluate future attempts by Congress or the FCC to regulate telephone companies' provision of video programming.