FDA panel overly cautious about genetic screening

March 9, 2011 More

An FDA advisory panel this week recommended that physicians oversee the ordering and interpretation of all genetic screeing examinations.  Let’s hope that the FDA rejects the recommendation of the panel – the panel should be directed to redo its homework and focus on the question of reliability and quality, not access.

FDA policy should be focused on improving access to diagnostic services by making them less expensive and more accessible.  This would be in line with the administration’s stated goals and our societial needs.  With an aging population and shortange of physicians (under current models of care), we need to “consumerize” more healthcare and health management, and that starts with cheaper access to diagnostics including genetic screening.  If there is a quality issue in how the tests are conducted and interpreted, there is a proper role for the FDA and FTC (as to marketing claims).

The only way in which we can expect achieve the twin goals of increasing personal responsibility for one’s own health and reducing the cost of healthcare is by adopting some of the knoweledge of the consumer products and software industries – volume drives down cost and provides the resources and experience to increase quality.  Make the testing affordable and accessible to create the environment for achieving policy goals.

For more about the advisory panel’s recommendation:

LA Times:  FDA panel advises caution on personal genetic testing

Business Week:  Genetic test makers defend technology before FDA

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