I think everyone in this space has been way off base as to what the problem is with FDA and Congress wanting to investigate the DTC Genomics companies.
The whole mindset is wrong.
What I hear from this debate is "It's my data, mine, mine, mine. Gimmee, Gimmee, you can't keep me from my data Big Brother!"
From Mr Goetz's Blog
"The controversy seems to have stirred the FDA to assert its authority – and that of physicians – over any and all medical metrics."
"To me, getting access to this information is a civil rights issue. It’s our data."
This is a straw man argument that has been set up to make regulating these companies seem unseemly and an invasion of privacy.
IT IS A DEAD WRONG ARGUMENT and I will not stand for it being perpetuated anymore.
This is not about getting access to your data.
Fine, you want a whole genome, go get it!
The FDA is not asking should people be able to go out and buy this. It is asking several other questions.
1. Is Interpretation of biometric data considered medicine?
The answer here is certainly confusing. I think it rests solely with intent.
Do you intend to tell someone something about a disease they now have based on this biometric data that you analyzed?
If the answer is yes, that is viewed legally and medically as a diagnosis.
Which ultimately I think is medicine and falls under medical regulations.
2. Is DTCG analyzing biometric data and intending to give an interpretation of that data which indicates a disease a person has?
It depends on what you define disease as.
Most legal experts defer to the International Classification of Diseases
3. Should we regulate a system which has not given indication of their quality control if they are indeed intending to provide medical diagnosis?
4. Are these methods of obtaining human samples to derive biometric data for the intent of analyzing and providing information about disease considered medical devices?
This is precisely the argument and precisely what Congress and the FDA are trying to define.
So stop acting like a bunch of little kids running around because someone took your kool aid away!
If I hear another, "It's my data" whine again I will scream.
This is not about restricting access to biometric data.
Which by the way, some states do already.
Is an EKG biometric data? What about a cholesterol?
Probably, no one is stopping you from going out and buying a machine to obtain this data yourself.
But any doctor will tell you, it is the interpretation that can vary widely. As demonstrated by the multiple interpretations that Venter et.al complained about
What they are intending to do is to prevent a third party from having NO ONE to answer to when providing interpretation of that very SAME biometric data.
The Sherpa Says: Regulation here will most definitely not stifle innovation as bad as a consumer death or class action lawsuit or lack of trust from consumers because of the aforementioned.