The latest in the 23andme versus FDA saga, in which the FDA halted 23andme from offering health-risk analyses of the genotyping service the company sells, comes in a commentary published yesterday in Nature. The commentary’s authors, Robert Green of Harvard Medical School and Nita Farahany of Duke Law School, address a key question raised by the FDA’s action against 23andme: Might the FDA expand its reach to regulate health-risk information derived from sources other than DNA, such as demographic, physical, or activity information? Green and Farahany find reason to fear that’s the case:
We find the FDA’s precautionary approach to 23andMe particularly troubling because it could presage similar actions against other consumer health products. In its recent guidance on mobile health applications, the FDA left open the possibility that it will regulate as medical devices information-based products such as questionnaires that evaluate the risk of a heart attack or the plethora of fitness trackers that help people to follow their weight, body temperature, heart rate, sleep patterns and more. Many operate as standalone or companion software for predicting risks including the likelihood of sleep disorders, seizures or heart attacks. Downloads and installations of these applications are expected to grow from 156 million in 2012 to 248 million in 2017 (ref. 10).
Such consumer products could democratize health care by enabling individuals to make choices that maximize their own health. They follow the historical trend of patient empowerment that brought informed-consent laws, access to medical records and now direct access to electronic personal health data.
Regulating such apps would essentially be treating analysis of information as a medical device. (“I wouldn’t eat that carbonara if I were you; could give you a heart attack.”) Green and Farahany may be overreaching themselves there, but it’s an important point to consider, and one that I’ve not yet seen FDA clarify.
Way too much about what the FDA wants here remains unclear.
via Regulation: The FDA is overcautious on consumer genomics : Nature News & Comment.
Quartz has good short write-up of the commentary, with information drawn from another study as well. New evidence shows the FDA was wrong to halt 23andMe testing
For lots of background — a whole trove of stories about this — see my ongoing round-up, I Got Your 23andMe – FDA Food Fight Links Right Here
Photo by @matpackery, rights reserved
Why does everyone think there’s some conspiracy about what the FDA is doing here? Isn’t its mission to protect consumers from harmful medical products? That’s certainly within the scope here. Anyone that knows anything about Chip genotyping understands that 23andMe’s product is worthless on the individual level without secondary validation of every hit. The same rules certainly should apply to Fitbits, Ups, and other monitoring devices. Their output needs to be accurate if consumers are using them to make lifestyle changes.