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Showing posts from March, 2011

Protect Genetic Testing: Petition the FDA

A simple genetic test is all it takes to know if hereditary hemochromatosis, the most common genetic killer in America, is in your genes. Your doctor can order this test or you can order the test yourself, direct from a reputable testing service. But that may change.

The Food and Drug Administration is seriously considering making some health-related genetic tests prescription-only. In other words, you would need your doctor's permission to get this and other tests. In some cases the results would go to your doctor, not you. We don't think such restrictions are needed. We think they would be detrimental to the public good and increase the cost of health care.  So we have organized a petition to express these views to the FDA. If you agree, please sign the petition.

Why Consumer Access to Genetic Tests Matters to You

Sadly, many doctors are overworked these days and simply lack the time it takes to stay abreast of the latest developments in genetics. We feel tremendous sympathy fo…

Comments to the FDA Meeting on Consumer Access to Genetic Tests

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The following comments were submitted to the Food and Drug Administration by Stephen Cobb, in preparation for the planned meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, said meeting to be held March 8-9, 2011, to discuss issues surrounding direct-to-consumer access to genetic testing.

FDA Comment Tracking Number: 80bfb28b

These comments represent my opinion as a consumer and as someone whose life has been permanently and negatively impacted by a genetic condition.

I think it would be a serious setback for public health in America if you decide to stop responsible companies such as 23andMe providing their current genetic testing services direct to consumers. I have used the services of 23andMe and have been impressed by the level of care and responsibility the company exercises in presenting health-related test results.

I see no benefit in requiring a doctor's prescription to get such tests or in placing a doctor between me and the facts…