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http://ssrn.com/abstract=1632528
 
 

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Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology


Jordan Paradise


Seton Hall University - School of Law

Alison Tisdale


University of Minnesota - Twin Cities - Dept of Sociology

Ralph Hall, JD


University of Minnesota, Twin Cities - School of Law

Efrosini Kokkoli, PhD


University of Minnesota, Twin Cities

December 2009

Journal of Law, Medicine & Ethics, Vol. 37, No. 4, pp. 598-624, Winter 2009

Abstract:     
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. The criteria we use for the assessment of oversight were developed through a multi-stage process. The first stage involved consultation of the legal, ethics, and public policy literature regarding oversight and collection of relevant written materials that address criteria utilized in oversight analysis. Searches were conducted using a variety of databases and resources. We refined these criteria and our vision of their relationships by consulting the literature on oversight analysis, through an expert elicitation process described elsewhere, and by consensus among the project investigators. The criteria chosen fell into four groups: (1) those associated with the development of an oversight system (e.g., establishment of policies, procedures, or regulations); (2) the attributes of an oversight system (e.g., how the system operates for particular processes or decisions); (3) the outcomes of an oversight system (e.g., economic, health, safety, and environmental impacts); (4) and the evolution of an oversight system (i.e., changes to the development, attributes, or outcomes over time). This article uses the assessment criteria and expert elicitation findings as tools to assess FDA oversight of drugs and devices and to derive lessons for effective oversight and regulatory mechanisms for nanotechnology. Section I describes nanotechnology in human drugs and medical devices and the state of oversight for those products regulated by the FDA. Section II describes the results of our expert elicitation research. Section III focuses on key criteria and ties them to the current literature and larger debate regarding regulation of human drugs and medical devices. We conclude with lessons for the oversight of nanobiotechnology.

Number of Pages in PDF File: 27

Keywords: Food and Drug Administration, nanotechnology, nanobiotechnology, drugs, medical devices, oversight

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Date posted: June 30, 2010  

Suggested Citation

Paradise, Jordan and Tisdale, Alison and Hall, JD, Ralph and Kokkoli, PhD, Efrosini, Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology (December 2009). Journal of Law, Medicine & Ethics, Vol. 37, No. 4, pp. 598-624, Winter 2009. Available at SSRN: http://ssrn.com/abstract=1632528

Contact Information

Jordan K. Paradise (Contact Author)
Seton Hall University - School of Law ( email )
One Newark Center
Newark, NJ 07102-5210
United States
Alison Tisdale
University of Minnesota - Twin Cities - Dept of Sociology ( email )
Minneapolis, MN 55455
United States
Ralph Hall, JD
University of Minnesota, Twin Cities - School of Law ( email )
229 19th Avenue South
Minneapolis, MN 55455
United States
Efrosini Kokkoli, PhD
University of Minnesota, Twin Cities ( email )
420 Delaware St. SE
Minneapolis, MN 55455
United States
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