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

historical perspective of personalized medicine; state of the science regarding biomarkers and diagnostics; drug development, diagnostics and personalized medicine; and taking research and development to the clinic. The theme of the second day was "Looking out for the Public's Interest" with sessions on "Testing in the Open Market" and "You, Biomarkers, and Your Rights." A session on "Looking Beyond the Science" raised ethical issues of how personalized medicine should be used to benefit patients and populations without compromising their privacy, their interests or their health. Morning panelists discussed how consumer tests are developed, marketed and regulated, and afternoon panelists considered personalized medicine from ethical, educational and policy perspectives.

Responding to another poll question, almost three-quarters of participants responded that they believe the public is getting information about personalized medicine from the Internet, rather than from doctors, friends and family or advertising and the media.

The second colloquium is scheduled for October 26-27, 2009 and the final one is scheduled for early 2010.

Other notable survey responses data include:

  • 74 percent of respondents believe safety and accuracy of diagnostic and other new technologies is the aspect of personalized medicine in which government's involvement can play the most important role in protecting patients.
  • 95 percent of respondents selected medical school or continuing education opportunities as the places where doctors should be learning about personalized medicine, choosing those over information derived from the Internet and pharmaceutical and device manufacturers.

The second colloquium is scheduled for October 26-27, 2009 and the final one is schedule for early 2010.

"This conference and the poll responses indica
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SOURCE Food and Drug Law Institute
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