"There's been a firestorm of discussion
on the Society for Participatory Medicine email boards - we're ranging from 'FDA are idiots' to '23andMe acted like they were above regulation,' and everything in
between.
My personal opinion is that the FDA is attempting to nail the barn door shut when the horse is two counties over, and running fast. I agree that DNA testing, and medical products that grow from that, need to be scientifically rigorous and subject to clear regulations. However, and I have to say typically, the FDA's language seems to parse into 'consumers are too stupid to understand the data you deliver, 'cause they're not MDs.'
We're still on the paternalism train. Driven by a 150YO steam locomotive ... "
Source: LinkedIn