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Full-Text Articles in Law
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 …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Ariel Katz
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 and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …
Rational Risk/Benefit Analysis Of Genetically Modified Crops, Stanley P. Kowalski
Rational Risk/Benefit Analysis Of Genetically Modified Crops, Stanley P. Kowalski
Law Faculty Scholarship
Safety concerns over the use of molecular biotechnology in the improvement of crops has generated substantial, heated and confusing debates, often driven by ideology and hysterics. Modification of crops is not new, and biotechnology (in its broadest sense) has been used for over a century to accelerate the development of new crops for food, feed and fibre, so as to meet the demands of a growing global community. The introduction of crops developed via molecular biotechnology [Genetically Modified Crops (GMCs)] represents the latest step in this inexorable innovative progression of technology. However, misinformed concern has led to a broad embrace …
National Cable & Telecommunications Association V. Brand X Internet Services: Resolving Irregularities In Regulation?, Amy L. Signaigo
National Cable & Telecommunications Association V. Brand X Internet Services: Resolving Irregularities In Regulation?, Amy L. Signaigo
Northwestern Journal of Technology and Intellectual Property
No abstract provided.
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 …
Structural Rights In Privacy, Harry Surden
Structural Rights In Privacy, Harry Surden
Publications
This Essay challenges the view that privacy interests are protected primarily by law. Based upon the understanding that society relies upon nonlegal devices such as markets, norms, and structure to regulate human behavior, this Essay calls attention to a class of regulatory devices known as latent structural constraints and provides a positive account of their role in regulating privacy. Structural constraints are physical or technological barriers which regulate conduct; they can be either explicit or latent. An example of an explicit structural constraint is a fence which is designed to prevent entry onto real property, thereby effectively enforcing property rights. …