Ok, it’s not really a court case… yet. However, from what I’ve read, it’s a pretty adversarial interaction. I’ve read a bunch of articles on the topic, already, and I have to say I’ve yet to see anyone state what I think is the obvious issue with the approach the FDA has taken.
They’re not regulating the equipment that does the testing.
They’re not regulating the interpretation of the information.
What’s left is that they appear to regulating the business model. It’s ok to do exactly what 23andMe is doing, but it’s not ok to do it if the consumer is uneducated. Were they handing the tests to an MD (who may or may not know what to do with the information) or a researcher (who may or may not have the ability to tell the subject of the test what the results are), it would be fine. As soon as it’s being handed over to a general consumer, it’s now going to be regulated.
I find that pretty hard to swallow.
If the FDA wants to regulate it as a medical device, then fine – regulate access to the medical device itself, and don’t try to regulate the burgeoning field of information interpretation and dissemination.
(Sorry for the lack of links – it’s been a busy week.)