FDA Takes One Regulatory Shackle Off 23andMe Gene Testing

Agency still treats consumers like idiots



Two years ago the FDA Shut Down 23andMe: Outrageously Banning Consumer Access to Personal Genome Information. Why? Because the agency's bureaucrats think that consumers are too stupid to understand and handle their own genomic information. The FDA ordered 23andMe to stop offering its popular Personal Genome Service that, among other things, alerted users to possible health risks related to their genotype screening results.

The New York Times today is reporting that the agency has relented somewhat and is now graciously allowing the company to offer genetic testing information to customers that relates to the risk of passing certain inherited diseases to their children.  The Times reports:

The new health-related information 23andMe will provide is called carrier status. That relates to whether people have genetic mutations that could lead to a disease in their offspring, presuming the other parent has a mutation in the same gene and the child inherits both mutated genes. There will be information on 36 diseases, including cystic fibrosis, sickle cell anemia and Tay-Sachs.

Whether that information, which is of most interest to people planning to have babies, will be compelling is unclear, and there are separate carrier tests available through doctors from other laboratories.

Ms. Wojcicki said 23andMe still hoped to gain F.D.A. approval to provide information on health risks, but she would not estimate how long it might take to win that approval.

Fortunately, those of us who were customers before the FDA crackdown still have access to carrier status results for 53 inherited conditions, that is, 17 more than the FDA is now authorizing. For what it is worth, I am clear for all the variants tested, except for Alpha-1 Antitrypsin Deficiency.

Early customers like me also still get information on 123 different health risks. This is specifically the information that the FDA is eager to deny consumers. The information is carefully presented with all kinds of appropriate caveats. According my results, I have elevated risks for illnesses like atrial fibrillation, age-related macular degeneration, and type-1 diabetes. With regard to all of them, I can say, so far, so good. On the other hand, I am at lower risk for gout, Alzheimer's disease, rheumatoid arthritis, and melanoma. Again, so far, so good.

Hooray for this small concession, but it is still outrageous that the FDA is stifling innovation and consumer freedom.