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Articles 1 - 9 of 9

Full-Text Articles in Law

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz Jan 2007

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 Jan 2007

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 ...


Compulsory Patent Licensing: Is It A Viable Solution In The United States, Carol M. Nielsen, Michael R. Samardzija Jan 2007

Compulsory Patent Licensing: Is It A Viable Solution In The United States, Carol M. Nielsen, Michael R. Samardzija

Michigan Telecommunications & Technology Law Review

As technology continues to advance at a rapid pace, so do the number of patents that cover every aspect of making, using, and selling these innovations. In 1996, to compound the rapid change of technology, the U.S. Supreme Court affirmed that business methods are also patentable. Hence in the current environment, scores of patents, assigned to many different parties, may cover a single electronic device or software--making it increasingly impossible to manufacture an electronic device without receiving a cease and desist letter or other notice from a patentee demanding a large royalty or threatening an injunction. Companies, particularly those ...


The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh Jan 2007

The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh

Michigan Telecommunications & Technology Law Review

Gaps within the drug distribution system make it increasingly vulnerable to bad actors, such as counterfeiters and terrorists. Congress intended the Prescription Drug Marketing Act (PDMA) of 1987 to close these gaps, but the PDMA has not fully succeeded. Important PDMA provisions that require tracking of drugs throughout the distribution chain in the form of "pedigrees" were set to be implemented as of Dec. 1, 2006, although a recent court order has stayed complete implementation. However, these PDMA requirements do not apply uniformly to all drug distributors in the United States. Moreover, since paper pedigrees can be forged, the pedigree ...


The Fcc Complaint Process And Increasing Public Unease: Toward An Apolitical Broadcast Indecency Regime, Kurt Hunt Jan 2007

The Fcc Complaint Process And Increasing Public Unease: Toward An Apolitical Broadcast Indecency Regime, Kurt Hunt

Michigan Telecommunications & Technology Law Review

[...]I propose depoliticizing the broadcast indecency regime by utilizing polling to determine the average broadcast viewer's opinion, divorced from all the pressures inherent in relying on the complaint process as a proxy. In section II, I will discuss the background and development of the broadcast indecency doctrine from the days of the Federal Radio Commission in the 1920s through the present day. I will also explain why the apparent increasing public unease is misleading, and why valid First Amendment concerns are steamrolled by the fiery nature of the debate. In section III, I will explain why the FCC's ...


Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher Jan 2007

Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher

Michigan Telecommunications & Technology Law Review

Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a ...


The New United States Model Income Tax Convention, Reuven S. Avi-Yonah, Martin B. Tittle Jan 2007

The New United States Model Income Tax Convention, Reuven S. Avi-Yonah, Martin B. Tittle

Articles

On 15 November 2006, the United States Treasury released its long-awaited new Model Income Tax Convention (“New Model”), which replaced the 1996 US Model (“Old Model”). This article reviews some of the major differences between the New and Old Models, as well as some of the major differences between the New Model and the current (2005) OECD Model Tax Convention. The article also discusses some new trends in US treaty policy which are not reflected in the New Model. The article concludes by evaluating the New Model in light of the emerging trend to use tax treaties not just to ...


Regulatory Beneficiaries And Informal Agency Policymaking, Nina A. Mendelson Jan 2007

Regulatory Beneficiaries And Informal Agency Policymaking, Nina A. Mendelson

Articles

Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to-consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise ...


Nsf Fees, James J. White Jan 2007

Nsf Fees, James J. White

Articles

Overdraft fees now make up more than half of banks' earnings on consumer checking accounts. In the past century, overdrafts have gone from the banker's scourge to the banker's profit center as bankers have learned that there is much to be made on these short term loans at breathtaking interest rates. I note that the federal agencies have been complicit in the growth of this form of lending. I propose that the banks and the agencies recognize the reality and attempt to mitigate these rates by encouraging the development of a competitive market.