How interested are you in knowing your risk of dying? If the whole truth is what you’re after, it may be closer than you think… as a new kit that tells you your risk of dying gets ready to hit the market.
23andMe Inc., which is backed by Google, has been marketing a $99 genetics test that will assess your risk for more than 240 health conditions. The only snag? They aren’t getting along so well with the Food and Drug Administration.
The FDA wrote in a†letter to 23andMe that after “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, you have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and the FDA has not received any communication from 23andMe since May.” Rut-ro. Over at Mother Jones, Kevin Drum†wrote off 23andMe as another start-up that “apparently believes federal laws apply only to ordinary mortals.” None of this is sounding good.
Luckily, the media attention seems to have sparked something within the company. “We recognize that we have not met the FDAís expectations regarding timeline and communication regarding our submission,” the company said in a statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.” They recently stopped marketing the kit until they can get their affairs in order.
As embarrassing as this whole public ordeal may have been, especially for a new company, it does raise the question of whether or not the rules that are currently in place by the FDA are necessary, not-to-be-messed-with parameters or just outdated laws that are getting in the way of groundbreaking inventions.
“The legal question is pretty simple,” said Daniel Carpenter, author of Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. “The definition of a device under the Federal Food, Drug and Cosmetics Act is anything intended for the use or diagnosis of a disease or other conditions.” These definitions were set up in 1938 and not updated much until 1976. According to the Washington Post, the personal genetic test and the personal medicine behind it didnít exist when the regulations were written.
If 23andMe is able to get off the ground, what it hopes to start is a traditional pay-for-product model where consumers pay $99 for a kit that helps them test and mail in their saliva, later receiving a genetic report on their health. In the long term, the company would like to take the genetic information they receive from their individual clients and study the data to help uncover medical connections, find disease markers and discover treatments. Really cool, so long as you’re okay with your information being used.
Since the FDA can’t really balk at allowing consumers to swab their own spit (not much risk there), they’ve instead focused on the fear of what these kinds of results might do mentally to the people who sign up for them. Sure, you might think you’re ready for anything… but what if you go through the process and find out you’re positive for a cancer gene. There’s the more serious idea that you might be so upset that you harm yourself, but there’s also the chance that you’ll undergo chemoprevention and intensive screening. But what if it was a false positive and another real problem goes undetected? I’d probably say better safe than sorry (though I’m sure the stress associated with the whole ordeal wouldn’t be very welcome). But the FDA isn’t buying it. The question then becomes, are they responsible for policing your reaction to possible bad news?
“This is a new problem, and we need a new regulatory architecture for it,” said Carpenter, who thinks the FDA should be focusing on ensuring that the science beneath these kinds of genetic tests is sound instead of worrying about how people might react to it.
So what do you think? Should kits like these be allowed on the market? What changes would you like to see before they’re made available? And should the FDA be more willing to bend on old rules, if the time and science calls for it?
Source: Washington Post
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