FDA's Current Ability to Regulate Genetic Testing is Problematic, FDLI-AAAS Colloquium Attendees Say
News Jun 30, 2009
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 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 indicate that personalized medicine will be an important issue for many years to come," said FDLI President and CEO Jim Kelly.
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