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Regulation: The FDA is overcautious on consumer genomics

A US drug-agency clampdown is unwarranted without evidence of harm, say Robert C. Green and Nita A. Farahany.

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Competing interests

R.C.G. leads several NIH research projects on genetic disclosure including one completed project, the Impact of Personal Genomics or PGen Study, (R01-HG005092) Scientists from two companies, 23andMe and Pathway Genomics interact with this study but have no control over data, analysis or publications. R.C.G. has, without compensation, contributed self-scripted, non-exclusive educational material to the 23andMe website. R.C.G. has not received personal financial support from any of the above entities; he has received support from the Brin-Wojcicki Foundation for an unrelated sequencing project.

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Green, R., Farahany, N. Regulation: The FDA is overcautious on consumer genomics. Nature 505, 286–287 (2014).

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