Regulatory and Medical Aspects of DTC Genetic Testing

Consumer Genetic Technologies: Ethical and Legal Considerations (Cambridge Univ. Press 2021)

NYU School of Law, Public Law Research Paper No. 22-31

17 Pages Posted: 20 May 2022 Last revised: 19 Sep 2022

See all articles by Catherine M. Sharkey

Catherine M. Sharkey

New York University School of Law

Xiaohan Wu

University of California, San Diego (UCSD)

Michael F. Walsh

affiliation not provided to SSRN

Kenneth Offit

affiliation not provided to SSRN

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

Sharkey, Catherine M. and Wu, Xiaohan and Walsh, Michael F. and Offit, Kenneth, Regulatory and Medical Aspects of DTC Genetic Testing (August 21, 2021). Consumer Genetic Technologies: Ethical and Legal Considerations (Cambridge Univ. Press 2021), NYU School of Law, Public Law Research Paper No. 22-31, Available at SSRN: https://ssrn.com/abstract=4108020

Catherine M. Sharkey (Contact Author)

New York University School of Law ( email )

40 Washington Square South
New York, NY 10012-1099
United States
212-998-6729 (Phone)

Xiaohan Wu

University of California, San Diego (UCSD)

9500 Gilman Drive
Mail Code 0502
La Jolla, CA 92093-0112
United States

Michael F. Walsh

affiliation not provided to SSRN ( email )

Kenneth Offit

affiliation not provided to SSRN

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