Loyola University Chicago, School of Law LAW eCommons Faculty Publications & Other Works 2018 Exploring Precision FDA, an Online Platform for Crowdsourcing Genomics Jordan Paradise Loyola University Chicago, School of Law,
[email protected] Follow this and additional works at: https://lawecommons.luc.edu/facpubs Part of the Administrative Law Commons, and the Food and Drug Law Commons Recommended Citation Jordan Paradise, Exploring Precision FDA, an Online Platform for Crowdsourcing Genomics, 58 Jurimetrics J. 267-282 (2018) This Article is brought to you for free and open access by LAW eCommons. It has been accepted for inclusion in Faculty Publications & Other Works by an authorized administrator of LAW eCommons. For more information, please contact
[email protected]. EXPLORING PRECISION FDA, AN ONLINE PLATFORM FOR CROWDSOURCING GENOMICS Jordan Paradise* ABSTRACT: The U.S. Food and Drug Administration has created an online platform for the next generation sequencing community, enabling users to evaluate biomarker in- formation and share resources. This article examines this online platform and offers sev- eral observations about potential legal and regulatory implications. CITATION: Jordan Paradise, Exploring PrecisionFDA, an Online Platform for CrowdsourcingGenomics, 58 JuRIMETRIcS J. 267-282 (2018). Precision medicine is here, with rapid advancements in the technologies, tools, and life-saving products entering the market for the treatment of serious and life-threatening disease. In May 2017, the United States Food and Drug Ad- ministration (FDA) approved the first cancer treatment for solid tumors based on a genetic biomarker rather than the tissue of origin.1 One month later, the agency approved a companion diagnostic panel that uses next generation se- quencing (NGS) to simultaneously screen a genetic sample for 23 cancer genes, three of which have FDA-approved therapies for non-small cell lung cancer.2 *Georgia Reithal Professor of Law, Loyola University Chicago School of Law.