Is FDA’s Crackdown on Direct-to-Consumer Genetic Testing a Violation of the First Amendment?
Association for Diagnostic and Laboratory Medicine (ADLM (formerly AACC))In November 2013, the U.S. Food and Drug Administration (FDA) ordered the company 23andMe to stop offering its direct-to-consumer DNA testing service, which provided individuals with $99 assessments of their genetic risk for almost 200 disorders. A thought-stimulating opinion piece published in Clinical Chemistry, the journal of AACC, now examines whether this move by FDA is a violation of the First Amendment, or a necessary step to protect consumers.