- Margaret HamburgFDA Administrator
FDA: Don't Ban Marketing of Home Genomics Kits Like 23andMe
23andMe has brought the genomics revolution to countless Americans at prices that would have been unimaginable just a few years ago. Already, over 500,000 people have used its innovative products to learn more about their ancestry, health risks, and genetic predisposition to a wide variety of factors.
But the Food and Drug Administration has just shut down further marketing of 23andMe’s $99 saliva home-test kit, effectively grinding their business to a halt. The FDA seems to think that Americans can’t be trusted with more information about their potential health risks because some people might make rash decisions with it. But hampering the sales of personal genomics devices isn’t the answer.
We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.
We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of hamstringing new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.
- FDA Administrator
Reverse the ban on marketing 23andMe's saliva home-testing kit, and focus future FDA efforts on educating doctors and patients about the benefits and limitations of genetic testing — rather than simply hamstringing innovative personal genomics products.
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