Have you heard the ads on the radio for 23andme? You can get your DNA tested and find out if you are predisposed to future suffering from any number of hereditary diseases.
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This could be useful information for a lot of people, right? Well, not necessarily. And especially not if the FDA has anything to do with it.
In a warning letter on Monday, the FDA ordered 23andMe to "immediately discontinue marketing" its genetic tests. Consumers have been mailing in a saliva sample and $99, and the six-year-old Silicon Valley start-up analyzes their genome to reveal information about their predisposition for some 250 diseases, as well as inherited traits and ancestry.
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The FDA lacks any specific statutory authority to regulate genomic sequencing technologies. President Obama knows this, because as a Senator in 2006 and 2007 he introduced bills that would regulate the genomics industry. They never passed. Yet in 2010 the FDA simply decreed by fiat that these tests are considered new medical devices that require premarket testing and approval.
23andMe has been working with the FDA on approval for years, and the agency's letter scolds the company for offering new tests and services before it has received permission for the older versions. Imagine an iPhone app that needed federal approval for every update. But behavior that would be considered visionary in Mountain View is the quickest way to offend the FDA establishment.
The FDA claims that 23andMe merely has to prove that its tests are safe and effective. But what does that even mean given that FDA's main concern seems to be what patients will do with the information the company provides?
By holding companies like 23andme hostage, the FDA and the Obama administration provide full employment for regulators, lobbyists, and lawyers. The economy stagnates but government for profit is booming in D.C.
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