The Genetic Age promises another exponential increase in human knowledge and potential. ... This article describes three frameworks the law uses to regulate genetic technology: (1) Individual Rights and Duties; (2) Scientific Regulation by Administrative Agencies; and (3) Legislative Preemption. ... This framework involves the lowest level of government oversight over genetic technology. ... At present, the FDA and National Institutes of Health (NIH) administer regulatory control of genetic technology as applied to human beings, but the jurisdiction of these agencies is limited. ... Attorney Judith Cregan has recorded a number of "serious problems" with FDA and NIH regulation of human gene therapy, including "concerns about patient safety, confidentiality of patient information, agency effectiveness, a lack of clear, adequate oversight for the industry, and a need for protection of proprietary information." ... Because genetic engineering of plants and animals has proceeded much further than human genetic engineering -- a number of genetically engineered crops have already come to market, while no human gene therapy treatments have been approved -- it is appropriate to consider, by analogy, legislative reaction to these agricultural products.
Journal of Contemporary Health Law and Policy
Wilson R. Huhn, Three Legal Frameworks for Regulating Genetic Technology, 19 Journal of Contemporary Health Law and Policy 1 (2003).