This is what I submitted to the FDA:

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I am angry that the FDA is considering limiting access to my own DNA. How is this within the scope of the FDA's authority? What is next? Will I be prevented from purchasing a glucose meter because I can not be trusted to know my own glucose levels? Maybe the FDA should outlaw the sale of blood pressure monitoring devices. After all, I might mis-interpret my own readings.

Here's what I suspect is really going on: The FDA is being pressured by the insurance industry to restrict consumers' access to their own DNA because of the information asymmetry between the government's preclusion of insurers ability to consider genetic data when determining eligibility and consumers' recently available ability to cheaply know if they have a predisposition for a variety of potentially expensive or life-limiting illnesses. That the FDA is likely pandering to this industry under the dishonest guise of consumer health protection makes me more distrustful of it as an independent entity.

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If my suspicions are right, this is a perfect example of how regulation begets regulation. The insurance industry is right to be scared of this government-mandated information asymmetry and the potentially horrific impact it might have on profitability. Imagine that everyone who new he had a high propensity for a degenerative disease made a very rational choice to buy nursing home insurance. The insurance companies would have little alternative but to price their products based on the the probability that those who are genetically predisposed to such illnesses would comprise the risk pool. This would likely price out a huge portion of the US population and effectively shut down the entire product category.

If we allow the insurance industry to do its own genetic testing, we will effectively take away the ability for a huge swath of the population to purchase life, nursing home, or health insurance. The effect would be that the US government would be the de facto insurer through Medicaid and other wealth transfer programs. And, because those who would find themselves un-insurable would not be contributing any of their own money toward their likely future care needs, the insurable population would indirectly pick up the slack through increased taxation or more government borrowing.

So, what can be done? Before we had our children, I imagined purchasing meta-insurance -- insurance that my children would be insurable. I wanted to buy this insurance BEFORE conception. My rate would be a function of my wife and mine's DNA testing, her health status, and her adherence to pregnancy best practices (don't get drunk, etc.). If we were quoted a high rate because our future children were deemed high risk, we would have to consider the moral issues of knowingly producing a child which could have a life of suffering (adopt instead, use a sperm/egg donor, etc.).

What would this insurance cover? I haven't thought through the mechanics, but I would like for such a product to allow the purchase of various health-related insurance products at rates not dependent on my children's genetic make-up or current physical condition. I would also like a nursing home-esque provision which would pay out if my children ended-up having expensive needs. [My otherwise healthy five year-old Aspie costs us thousands a year in non-covered services (social skills group, etc.). I can't imagine having a kid with CP. etc.] Imagine having a kid with Downs' Syndrome. How much money would you need so that your lifestyle would be the same as if your kid was born healthy?

The insurance would be sold as follows: Upon receiving a price quote, I would obligate myself to purchase the insurance if we conceived a child which was born alive and lived for more than N months. The obligation aspect of the product is designed to prevent an obviously nasty selection bias effect.

So, why is this insurance not available? Current government regulations coupled with social welfare programs take away the incentives. Let's presume that, if the US because a libertarian-esque country that the majority of children born would not be insured in this way -- after all, we have lots of evidence that many parents can't even provide immediately necessary things for their children. [Note that I consider myself a weak libertarian.] And, let's presume that letting children suffer is politically unacceptable. What if the government effectively privatized a huge swath of its social welfare programs by offering this insurance for free -- genetic testing be damned. The effective future payment stream would not be much different than it is today because the government pays for poor sick people anyway. We could rid ourselves of many layers of regulation and allow the free market to do what it does best.

I am strangely hopeful that the availability of direct-to-consumer genetic data will necessitate such a change in the ways US citizens have to mitigate health-related risks. Unless we peel back the layers of regulation already in place and offer market-centric replacements for their intent, we will see more and more inefficient layers added over time.