Regulatory and Medical Aspects of DTC Genetic Testing
Consumer Genetic Technologies: Ethical and Legal Considerations (Cambridge Univ. Press 2021)
17 Pages Posted: 20 May 2022 Last revised: 19 Sep 2022
Date Written: August 21, 2021
Abstract
The recent Food and Drug Administration (FDA) marketing authorizations granted for testing mutations associated with hereditary breast and colon cancer, as well as pharmacogenomic susceptibilities, provide an opportunity to reexamine the medical as well as regulatory underpinnings of direct-to-consumer genetic testing (DTC-GT). In this chapter, we make the case for federal regulation of DTC-GT at two levels: protecting consumers/patients who access particular tests and building an informational environment for genetic testing that supports innovation in the aggregate.
Keywords: FDA, DTC genetic testing, DAIA, VALID Act, precertification, de novo, third-party accreditation, big data, information aggregator
JEL Classification: I18, K23
Suggested Citation: Suggested Citation