Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology
Journal of Law, Medicine & Ethics, Vol. 37, No. 4, pp. 598-624, Winter 2009
27 Pages Posted: 30 Jun 2010
Date Written: December 2009
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.
Keywords: Food and Drug Administration, nanotechnology, nanobiotechnology, drugs, medical devices, oversight
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