23andMe is incredibly naive. >The FDA has been asking 23andMe for specific studies on the reliability and efficacy of its DNA test results as well as specific

23andMe is incredibly naive. >The FDA has been asking 23andMe for specific studies on the reliability and efficacy of its DNA test results as well as specific clinical analysis regarding health claims (for example, the risk of developing a condition that is associated with a genetic marker). Makes sense. You're making certain medical claims, you darn better have something to back it up. What's their answer? Well: >23andMe says it is working on satisfying those mandated requirements and admits it wishes its efforts were farther along. Well, then you can't make those claims!!! What the heck did you expect the FDA to do!? Give you a break? Just this one time?! > At the same time, 23andMe contends that the reliability of its test kits and data adheres to the highest standards, that its process matches that of a DNA test one would get through a physician. PROVE IT! The reason why they haven't, I'm sure, is because it's expensive and time consuming. And possibly because the regulations around commercial DNA testing is out of date, maybe, but it is what it is. >Last spring 23andMe began to ramp up the marketing efforts behind its DNA kits. This included TV and video ads and a direct-marketing campaign. Of course that would be a problem. How you market your medical product factors greatly in whether or not you're going to be audited! Is this surprising to anyone at 23andMe !?!? >Given the long history of dialogue with the FDA, you might imagine that 23andMe would have sought feedback about these initiatives--to see if any concerns surfaced or tweaks were requested The FDA doesn't works like that. You're not going to get an a priori go ahead from them. The way it works is YOU have all YOUR homework done and ready, then go and market, and then if you get audited (and the FDA reserves the right to audit you anytime) the onus is on you to prove that your claims are sound and backed-up by proper evidence, that your quality system is in place and that your product is correctly classified and registered. If you don't have that, you get shut-down, and possibly more. >The FDA, in turn, took no steps in the wake of this marketing wave to reach out to 23andMe and suggest caution or areas of concern. The FDA is not your personal auditor or adviser. They don't work on your schedule. They aren't there to hand-hold 23andMe while they take their product to market. Sometimes when you release a product in a new category, it may take the FDA a long time to come up with the right procedures and to amend the proper regulations, but them's apples. You don't go out, do what you want, and then be surprised when you get shut-down.