> More than five years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the [testing service]," the letter states. It also says that in January 2013, 23andMe claimed that it was doing further testing for its approval application, testing that would take several months to complete; nearly a year later, it never submitted the results of the testing.
And maybe because the FDA is stupid and thinks that the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information. Ignorance is the only safe option!
The FDA's theory here, though, is that since 23andme goes beyond just saying "You have the G:A variant of Rs601338" to "You are probably as susceptible to norovirus infection as a typical person" they're not just a medical laboratory but also a medical device manufacturer, and therefore come under the FDA's purview with much stricter tests for what they can market and what sort of tests their product undergoes.
To me, that sounds pretty ridiculous since you can easily just go on SNPedia to look up the associated information yourself[2].
[1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... [2]http://snpedia.com/index.php/Rs601338
Would you want a physician picking your drug regimen based off of what Wikipedia says on some particular day? Would you like your implanted defibrillator to change its algorithm based on something Wikipedia says?
If not, then you've discovered the crux of the issue. There's a bright line between "data that someone put online yesterday" and "rigorously tested and proven effective". That's the whole point of FDA regulation on what gets to be marketed as a medical device, or what drugs can be prescribed for an indication.
So I take it you don't drive, don't own a residence, don't have a bank account, don't own a business, ...?
Because I'm being downvoted, I feel the need to take a stronger stance: sometimes, information is more harmful to a person because we do not always act well on it.
I decided not to view information about Alzheimer's and Parkinson's because the abnormality they reveal is a genetic variant that you cannot, like, read crossword puzzles to avert. It's just bad news. If I find out that I don't have the variants then all I've done is crossed two variants of two diseases of thousands. It's not worth the spin of the roulette wheel.
Normally this would be revealed by a genetic counselor and context given. Personally, I wouldn't view this information no matter what.
BRCA is another issue. I think BRCA is _very_ important information, since a mastectomy and possible hysterectomy can greatly reduce chances of the resulting cancer. But this information needs to be given with immediate context and guidance, and now how 23andme presents it.
I was also kind of astounded that 23andme doesn't even prompt you whether or not you want to find out if you're a Tay-Sach's carrier or not. That can be enormously significant news. I turn out to have the variant that tends to test false positive, but I was still unhappy to be given that information without my prompt.
This is the only case in my life where I've thought that a piece of information should be regulated.
The phrase "information regulation" is deeply scary to me. This is dangerous turf. But I think that this is the right decision at the time.
The FDA wanted it removed or justified -- assuring this with regard to medical devices is one of the things FDA is charged by Congress with doing. So, unless you can point to how the FDA isn't doing what it is charged to do, the blame either goes to 23andMe or to Congress, depending on how view the appropriateness of Congress's charge to the FDA.
Yes, it is.
> The FDA creates its own regulations. It doesn't just follow laws passed by Congress.
It creates regulations (and enforces them) as a means to executing the role Congress has given it. So, again, if you don't have an argument for how what the FDA is doing is inconsistent with the statutory purpose it has been given by Congress, your beef is with Congress, not the FDA.
I don't think this balance is as cut and dry as you claim it to be. There are very few "actionable" results that you can get from a 23andMe test right now, whatever they say to the contrary. The meat of the report that they currently provide is a list of alleles and associations to various properties, but there are thousands of alleles (and likely millions more not tested for lack of known associations) that sum to your particular phenotype. The math and science behind that summing process is severely lacking at this point, simply because we have not characterized the billions of interactions between them.
The FDA's problem with 23andMe is that they are not properly communicating this uncertainty in their marketing. Relevant to this issue is whether the reports can be called "medical" information or not. In order for things to live up to the standard of "medical" devices or therapies in the US, they have to pass a certain measure of QC, accuracy, and demonstrated efficacy. 23andMe hasn't done the legwork for any such tests, and from most accounts, it seems like the FDA has given ample effort to accommodate them so far.
This is not about hiding data from ignorant people. 23andMe will likely go on testing and providing reports. It just can't advertise it as "medical" until it passes the same standards as other medical products, just the same way I can't sell "Grade A" Beef unless it passes certain standards, or sell "bourbon" in the US unless it's aged in a charred-oak barrel. That is because we've decided as a society to link certain labels with standards, and the label would be pointless if it weren't applied consistently.
If only 23andme had a pair of balls ... this should really end up in court where we can clearly draw a line the FDA can't cross.
Because it was being marketed as a health product, not a novelty product.