From Alex Tabarrok:
The Food and Drug Administration on Friday ordered five companies that offer genome-sequencing tests to consumers, or that provide the scientific services for them, to prove the validity of such products.
The FDA said the tests, which scan a person’s DNA for gene variants associated with specific diseases, are medical devices requiring the agency’s approval.
The ability of genetic tests to predict diseases is currently limited; if the FDA were simply to require firms to acknowledge this point, say with a clear statement of probabilities, that would be one thing (although this task is better met by the FTC under advertising regulation). But the FDA is brazenly overreaching in trying to regulate genetic tests as medical devices. First, there is no question that these tests are safe–safer than brushing your teeth!–and also effective in identifying genetic markers. Thus, there is no medical reason whatsoever for regulation.
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.
Just watch how fast comments pop up defending the FDA here. It’s as if people forget that 99% of our lives run perfectly well without big brother “regulating” it and they feeble imaginations could never get their minds around the fact that FDA over-regulation kills people – more people than it saves – and that other mechanisms have and do exist to serve the function that this regulation is intended to do.
Let me ask them a question, if George Bush was running the FDA, would they still feel the same way about all of this?