The FDA and 23andMe: Violating the First Amendment or Protecting the Rights of Consumers?
Clinical Chemistry Podcast · Association for Diagnostics and Laboratory Medicine
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Show Notes
One of the largest direct consumer genetic testing facilities, 23andMe, was ordered by the US Food and Drug Administration to cease marketing its Personal Genome Service test in late 2013. This occurred after 23andMe failed to respond to questions that the FDA had about the analytical and clinical validity of this test. While some support the FDA's actions because of the test potential for harm to consumers, some advocates of the technology fault the FDA for being overly paternalistic and impeding medical advances.