23andme and the FDA

The FDA sent the following warning letter to the direct-to-consumer genetics company 23andme. The essence of the letter is:

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body….

…Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.

The FDA seems to be saying the report is a device and that 23andme hasn’t proven that the device works, and that they must stop selling genetic reports until they do so. For me, this is a bit odd, as a report is not a device. I agree that many/most people don’t know what a lot of the information provided means, and almost no one knows what some of it means. And I think the personal genomics ‘revolution’ has always been oversold. However, there are all sorts of sources of information that people don’t understand. There well may be a regulatory role for FDA, but this seems to call for a different category of oversight.

This tag will get you to several posts I have written about the use of genetic markers for underwriting private long term care insurance.

Update: Brad Flansbaum via twitter asking about evidence of such reports driving utilization of care that may not be warranted. I don’t know of studies, but this Bloomberg news story notes United Health Care’s worries about such direct to consumer testing increasing utilization.

Lots of folks talking about the 23andme v FDA blow up yesterday/today. A quick round up

About Don Taylor
Professor of Public Policy at Duke University (with appointments in Business, Nursing, Community and Family Medicine, and the Duke Clinical Research Institute). I am one of the founding faculty of the Margolis Center for Health Policy, and currently serve as Chair of Duke's University Priorities Committee (UPC). My research focuses on improving care for persons who are dying, and I am co-PI of a CMMI award in Community Based Palliative Care. I teach both undergrads and grad students at Duke. On twitter @donaldhtaylorjr

One Response to 23andme and the FDA

  1. Jim Burnetti says:

    Our family all sent samples to 23andme and learned that this good Polish Catholic family has some Ashkenazi Jewish genes. Consistent across generations. FDA has to stop living in the past. No one is going to make a decision like a mastectomy based on a $99 test, but it might prompt you to have your doctor do a test subject to more rigorous QA/QC. Genetics isn’t all rocket science these days. Technology advances. Decades ago, people could not have conceived of the high resolution commercial satellite images we have today.

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