FDA Inching Closer to Regulating Home Genetic Tests

The Molecular and Clinical Genetics Panel of the Food and Drug Administration’s (FDA) Medical Devices Advisory Committee met earlier this week to consider Direct to Consumer Genetic tests.  This is consistent with previous FDA actions that suggested the agency would consider such tests as needing FDA approval.  Currently the FDA only regulates prescription genetic tests, not those that you can order without intervention by a medical professional.  The Panel recommended during its meeting (H/T The Scientist) that genetic tests should only be allowed when a doctor helps the patient interpret the results.

The recommendation is not binding on the FDA.  However, activity last summer suggested that the FDA is sympathetic to such a recommendation.  And the FDA is not alone in its skepticism of how effectively genetic test results can be assessed by consumers.  The Presidential Commission for the Study of Bioethical Issues spent part of its recent meeting on genetic testing issues and will likely study it further.  The U.K. recently offered guidelines for how to market and use direct to consumer tests.  It seems unlikely that the FDA won’t offer some kind of guidance, if not regulation, to ensure that the benefits (and limitations) of the knowledge generated by genetic tests is best presented to consumers.  Because, as a 2006 Government Accountability Office report indicated, it’s way to easy to mislead consumers (unintentionally or not) with results of these tests.