Last Friday, the Food and Drug Administration sent a letter to the most popular personal genomics service, 23andMe, ordering the company to stop selling its genetic testing kits. According to the FDA’s letter, the company has been advertising that its tests offer diagnostic information for a variety of human conditions, placing them in the category of a “medical device” and thus within the agency’s jurisdiction. Accordingly, the FDA has been working with the company since 2009 to get 23andMe’s testing approved. Now, the FDA has apparently run out of patience.[More]
This is an important step along the way to personalized medicine. Who has control of our genetics? Who can inform us of the consequences? How do we protect ourselves frmo charlatans whose ‘advice’ could be deadly?
The FDA was created in order to deal with similar questions about drugs. But now it is looking at something much more complex and disruptive.
Who has the right to inform us about our bodies? How should they be regulated? There needs to be some but they will not be able to stop this.
Because it won’t just be doctors anymore.