Apr 26, 2011 - News

Public Comments Due on Possible FDA Regulation of Direct to Consumer Genetic Testing

From its founding 23andMe has made clear its views that people should have a right to access their own genetic information.

And in the debate over regulation of direct to consumer genetic testing, we’ve made our views clear to officials at the Federal Drug Administration (FDA).

Have you?

May 2nd marks the deadline for people to offer their comments on possible regulations of the industry by the FDA. Those regulations could decide whether people can continue to have direct access to their own genetic information.

For 23andMe, giving people access to the rapid advances in personal genetics does more than just empower people with information about their health and ancestry, it can also enlists them as partners in important research.

23andMe has already shown the power of changing the research paradigm with such things as its Parkinson’s disease research initiative, which already has more than 4,000 participants and promises to advance science in the field. 23andMe scientists have tapped into the power of linking its community of users and their DNA data to develop new insights into genetic associations for common traits. That model has already been used to gain insight into more serious medical conditions.

While we understand there are challenges in giving genetic information to consumers, there is no data or scientific study to support arguments that giving people their genetic information could lead them to make harmful decisions. Indeed, there is evidence that this information can encourage consumers to be healthier, and that doctors play an important role in working with these individuals to make lifestyle changes.

The deadline for public comments on this topic is Monday. Those comments can either be sent electronically or they can be sent by mail. Letters should reference docket number FDA-2011-N-0066 and be addressed to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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