Today, the Food and Drug Administration published a letter giving the company two weeks to discontinue marketing the kit, which the agency classifies as a medical diagnostic device in need of approval.Welcome to today's hyper-regulatory environment. How does this product relate to either food or drugs? They are simply providing a service by educating people with genetic information about themselves. Why would that need to be approved? 23andMe has not yet responded.This is yet another example of government overreaching because it can.
According to the letter, the FDA has been seeking information needed to approve the test for a while, "including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications"
Monday, November 25, 2013
More Government Overreach: 23andMe Ordered To Cease and Desist
The FDA has ordered the company 23andMe to stop providing its genetic overview and genealogy results package, which the agency describes as a "medical diagnostic device in need of approval." From the story in Popular Science:
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Your kidding, right? You do not think a government agency should reasonably supervise a medical diagnostic product? What if Ken Ham started to produce them to raise money for the Ark project? Would you want that quack to sell genetic test kits? Got to be some boundaries, agreed, but not here.
ReplyDeleteFrom the story in the New York Times:
ReplyDelete" The F.D.A. action is the latest salvo in a long-running debate about whether and how such tests should be regulated.
On one side are some doctors, geneticists and state regulators who say the tests should be regulated because the results might be used to make medical decisions. Some also say a doctor should be involved in ordering the tests and interpreting results.
On the other side are those, especially 23andMe executives, who argue that the services merely provide information, not medical diagnosis, and that consumers have a right to the information contained in their genes. At a time when consumers are taking more control of their health care, denying them such information would be, as one director of 23andMe recently put it, “appallingly paternalistic.” "
I have read the disclaimers on the 23andMe site and they don't provide advice or clinical expertise, only information on the genetics of an individual. I don't have trouble with anyone marketing that kind of product as long as people know how the tests are run, who is doing them, what the risks are and how to use the information.
Maybe I am incorrect in this assessment and I understand that this entails a sort of "buyer beware" attitude but I have become very leery of government interference where it is not necessarily warranted.