The Food and Drug Administration (FDA) sent notice to 23andme co-founder and CEO, Ann Wojcicki, to stop selling the company’s direct-to-consumer genetic testing kits because the company was acting “without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act” (See full letter from the FDA). As the company seeks to provide medically relevant information to consumers, it is being required to seek FDA approval for the test which was first released in 2007.
The letter from the FDA sites that the federal organization has been working with 23andme to resolve many issues related to marketing and clinical validation of PGS (Personalized Genome Service) so several years without receiving the requested information and data, while 23andme has continued to expand marketing and the uses of their product.
I’ve previously written my opinion about personalized genomic testing like what’s offered by 23andme, cautioning my friends to see it as entertainment only. Personally, I believe this new action by the FDA is a win for the consumer. Any test being marketed directly to the consumer (without a physician ordering the test) that claims to provide information that can be used to inform medical/lifestyle changes should be regulated. One would assume that most folks would consult a physician before making lifestyle changes based on genetic risk information from tests such as that offered by 23andme. However, I fear that operating under that assumption is probably not very wise. With expanded clientele through television advertisement, the chances of inappropriate use and interpretations of genetic tests outside the realm of physician and genetic counselor consultation are likely to increase.
Here are some other reports on FDA’s action on 23andme: