Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 4 of 4
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 …
Food Safety, South-North Asymmetries, And The Clash Of Regulatory Regimes, Obijiofor Aginam
Food Safety, South-North Asymmetries, And The Clash Of Regulatory Regimes, Obijiofor Aginam
Vanderbilt Journal of Transnational Law
This Article explores the globalization of food safety concerns driven by the phenomenon of economic globalization, and the "legalization" of food safety disputes within the rules-based architecture of the World Trade Organization (WTO). Focusing on the interaction between WTO norms and the treaties of other multilateral organizations, the Article discusses the implications of the "clash of food safety regulatory regimes" for South-North asymmetrical relations between the rich and poor countries. The Article also discusses global economic diplomacy and the emerging WTO jurisprudence on the Agreement on Sanitary and Phyto-Sanitary Measures (SPS) disputes. This Article explores both the perceived and actual …
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 …