IF you want to sell a genetic test, you need to prove to the FDA: (1) that your test is accurate and reproducible, (2) that whatever conclusion you draw from the test is scientifically sound.
The issue was that 23&Me was saying "you have this SNP, that means your risk of X is increased by Y%". The test, the result and the conclusion is not based on a rigorous testing. Hell, some of the risk associated with SNPs is coincidental at best.
That said, I'm fine if people want that info anyways, but 23&Me would need to add a disclaimer that says "Your genetic test results and the risks attributed to them may or may not be accurate."
Which devices and drugs were 23&Me selling? I thought it was just crowd-sourced information about traits.
Think how ridiculous it would be if the FDA just shut down a crowd-sourced database about trait correlations. But suddenly when a company like 23&Me correlates the two, it becomes pure, concentrated evil that must be subject to regulation.
They were marketing their genetic testing kits and related services for diagnosing genetic diseases and risks. That made it a "medical device" within the scope of the Food and Drug Act, which means that they needed to actually have specified level of testing establishing the validity of the things its was being used to assess.
The FDA noticed the violation, notified 23andMe, said, if you want to keep doing this, you need to meet the requirements, and please tell us how you plan to come into compliance. And 23andMe blew them off for quite a while, so the FDA enforced the law.
It's not a stretch to imagine someone acting on that information with potentially dangerous results; taking extra unneeded supplements, having elective surgery, dramatically changing their lifestyle to reduce the risk of some condition, etc.
The difference is that Illumina did things legally (including hiring clinical genetics analysts who pored over the details and made a number of calls about what was significant).
23&Me did not. They were doing something that they would have known was illegal. The FDA explained this to them, and 23&Me blew them off. Failing to respond to an accusation from the government is an amateur move and 23&Me deserved what they got. They only went back and negotiated afterwards.
You're complaining the government was restricting your freedoms but we have more than adequate evidence that 23&Me was acting irresponsibly.
Then I promptly uploaded my genome including the VCF files they used for risk screening, https://my.pgp-hms.org/profile/hu80855C
Anybody on the internet is free to analyze my genome.
What's been your experience with analysis? Something that can be picked up, or something that the professional insights you got were far more useful?
Personally I found it less than useless, since I can't reasonably conclude I have no risks. I know enough genomics to conclude that beyond a few well understood cases, genomes have little medical predictive ability.
But they FDA doesn't allow it, even under this condition.
I think it's ridiculous that the FDA considers this okay:
A) "1,2,3-methyl dethyl has been proven in clinical research to make your life suck less. (This statement not evaluated by the FDA blah blah blah)"
But not this:
B) "You have genes X, Y, and Z. The current state of published researched indicates an elevated risk for skin cancer for this genotype."
Was anyone seriously claiming that 23andme was misrepresenting the state of the research? Were they providing or enabling any treatment based on this research without further review by a doctor?
"1,2,3-methyl dethyl has been proven in clinical research to make your life suck less. (This statement not evaluated by the FDA blah blah blah)"
I'm assuming you saw that on a dietary supplement? That would never fly for an approved drug. Take a look at the FDA website to see what kind of promotion they crack down on. There was a ADD drug company that had an ad with a kid studying and the slogan "He can finally get his homework done". The FDA came down hard on them and said "where is the clinical trial showing that academic performance improves?".
As other posters have stated, 23&Me got busted, submitted a 510(k) (approval of medical device) and then when the FDA came back with questions, they failed to reply. You can find it all in the numerous FDA warning letters.[1]
[1]http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...