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Full-Text Articles in Law

The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew Dec 2007

The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew

University of Michigan Journal of Law Reform

This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so ...


The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm Jan 2007

The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm

Michigan Telecommunications & Technology Law Review

Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free ...


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 ...


Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss Jan 2007

Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss

Michigan Telecommunications & Technology Law Review

Since the Patent Act was revised in 1952, patent law has expanded to cover an array of novel endeavors--new fields of technology (notably computer science and business methods) as well as the activities of researchers engaged in fundamental scientific discovery. These changes have been accompanied by shifts in the organizational structure of the technological community, with smaller firms and universities emerging as important players in the patent system, and by new marketplace expectations arising from consumer demand for interoperable technology and converging functionality. As a result of these developments, structural flaws in the legal order have become evident. Although the ...


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 ...


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 ...


Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann Jan 2007

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit'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 Use Of Drug Testing To Police Sex And Gender In The Olympic Games, Haley K. Olsen-Acre Jan 2007

The Use Of Drug Testing To Police Sex And Gender In The Olympic Games, Haley K. Olsen-Acre

Michigan Journal of Gender & Law

Part I of this Article discusses the history and development of sex testing and drug testing and argues that the two are both historically and ideologically linked. Part II examines the current Code in detail and argues that the Code's focus on hormone-based controls acts to police sex and gender in Olympic athletes, thereby extending historical sex testing practices to a new era. This Article ultimately concludes that without recognizing and addressing the need for further research into the role of "sex" hormones in the body and the interplay of social context and biological circumstances, the IOC cannot maintain ...


Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman Jan 2007

Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman

Michigan Journal of Gender & Law

This Article will demonstrate that a pharmacist's refusal to fill a valid prescription for emergency contraception constitutes sex discrimination and violates the WLAD. Part I explains the nature and function of emergency contraceptive pills (ECPs) as well as their role in basic health care for women and the importance of their accessibility. Part II addresses federal civil rights protections and the failure of these protections to provide relief for women facing refusals. Focusing on the WLAD, Part II also explains how state public accommodation statutes protect women from discrimination in places of public accommodation. It further sets forth the ...