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Abstract

This Note examines the existing gaps in regulating genetic tests that are sold directly to consumers and the arguments for and against greater regulation. It advocates adopting an approach that shores up existing regulation of the accuracy of genetic tests under the Food and Drug Administration and Clinical Laboratory Improvement Amendment, while continuing to promote an open market for selling tests directly to consumers. The Note looks to a variety of additional mechanisms for providing further consumer protections such as incentives for voluntary participation in the Food and Drug Administration approval process, an expanded watchdog role for professional organizations, and education programs for consumers and physicians.

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