The idea that the FDA can regulate and control what individuals may learn about their own bodies is deeply offensive and, in my view, plainly unconstitutional.
But the FDA's request is common sense: They're asking the producers and marketers of genetic tests to prove their scientific validity, a necessary step given that people could -- and often do -- make potentially costly or dangerous decisions about their health based on the results of these tests. Tabarrock doesn't answer this argument in his post; he simply focuses on the fact that collecting genetic material for the tests is safe. But without evidence that a test works, how can consumers make safe decisions? Given the relative novelty of this technology, scientific evidence doesn't seem like much to ask.
The policy obviously has market consequences that may slow the widespread use of genetic testing, but that's a trade-off we should be willing to accept -- as far as I know, anyone can market a genome-testing device without supervision. Meeting these standards shouldn't be too onerous for legitimate firms, epecially given that companies like 23andMe have promised scientific rigor.
On the other hand, Tabarrock's position -- that asking medical companies to provide evidence for their claims is tantamount to "control[ing] what individuals may learn about their own bodies" -- is over the top. Just compare it to the FDA's original efforts to regulate patent medicine in the earlier part of the last century -- does Tabarrock think that requiring drugmakers to prove the validity of pharmaceuticals is an unconstitutional attempt to control what substances people put in their own bodies?
Update: I mistakenly attributed this ideas to Tyler Cowen, but Tabarrock was the author of the post in question.
-- Tim Fernholz
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