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FDA's Current Ability to Regulate Genetic Testing is Problematic, FDLI-AAAS Colloquium Attendees Say
Date:6/22/2009

Personalized Medicine Meeting Elicits Varying Perspectives

WASHINGTON, June 22 /PRNewswire-USNewswire/ -- The Food and Drug Administration's (FDA's) ability to regulate genetic testing is problematic, according to a recent polling of personalized medicine stakeholders.

Three-quarters of the attendees at a colloquium on personalized medicine, sponsored by the Food and Drug Law Institute (FDLI) and the American Association for the Advancement of Science (AAAS) responded "yes" to the audience question, "Do you have concerns about the ability of the FDA to regulate genetic testing?" However, 72 percent of the attendees also responded that FDA should be charged with ensuring standardization of testing protocols and interpretation across labs, clinical validity of testing and clinical usefulness of tests. And 71 percent agreed that FDA should regulate genetic testing, including laboratory-developed testing, more stringently. Genetic testing is regarded as a key component of personalized medicine.

Finally, half of the respondents were somewhat skeptical that their own doctors know enough about personalized medicine to effectively incorporate genetics into the care of their families, while 28 percent said there was "not a chance" that their doctors knew enough. Only 2 percent were "very confident" that their physicians could effectively incorporate genetics in personalized medicine

The first of a series of three colloquia on personalized medicine sponsored by FDLI and AAAS took place at AAAS headquarters in Washington, D.C., and was attended by more than 200 participants both on site and via webcast. Physicians, scientists, attorneys, consultants, insurance representatives and other personalized medicine stakeholders brought varying points of view at the two-day event. The first day's sessions focused on diagnostic tools and their clinical utility, featuring sessions on
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SOURCE Food and Drug Law Institute
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