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






  • Jamie

    I emailed the FDA. It would be ridiculous to take away peoples’ rights of their own genetic information. I am sure this has been and will continue to be beneficial in the medical community; but how do they expect research to continue if people are not willing to give their DNA if they do not have the right to see the information themselves?

  • Frances Bennett

    I think your service is invaluable for personal, and particularly medical reasons. I hope fervently that it is spared control by outsiders.

  • albert maguire md

    My results motivated me to see my internist and get a real time medical evaluation.

  • shirley grose

    Below is my comment to the Regulations.gov site.

    ← ← We need to not hoard the human genome. We need the information the personal genome can give us to work with our doctors to take care of our health, even when the information might not be quite perfect. We are in the initial stages of a revolution in molecular biology. To move ahead, the FDA must acknowledge that we own our genome, not the government, not the doctor. The FDA must not strangle the genetic babe in it’s crib. The FDA must not sacrifice control of the human genome to medical lobbyists with selfish interests.
    ← ←
    ← ← In my eyes, at one time the FDA was up there with Mom’s apple pie, the Fourth of July, and Sunday dinner. The FDA was there to safeguard our lives. The FDA watched over our health. The FDA worried for us. The FDA was respected. The FDA watched over the medical system.
    ← ←
    ← ← My perception, now, is that the FDA is broke: the medical system barely works for the upper middle class, and doesn’t work for most other classes. The medical system is stuck in the last century. The FDA must support personal genome testing without restrictions that strangle it in the hope that our medical system can advance into a new paradigm, a new century, and lead other nations in health. The FDA needs to smell like apple pie again.
    ← ←
    ← ← Predictive medicine and the personal genome might change the outcome of the worst diseases, lessen the financial impact of increased age, increase longevity, productivity. Not to mention it might be more humane. Modern medicine is archaic. We need predictive medicine. We need patients involved with their own health who own a stake in their own genetic health.

    ← ← It is our decision, what we do with our genomic information, not the FDA’s, and because it is our decision, and because we can learn from our genome about our own biology, medicine will change to accommodate all people. After I tested my life changed. I participated in 23andMe, January 24, 2011

    Comment Tracking Number: 80c3d546
    May 1, 2011 comment to Regulations.gov site

  • shirley grose

    I posted a comment on Docket number FDA-2011-N-0066 I just posted a revised comment on Regulations. Comment Tracking Number: 80c3dc1d

    My public comment for possible FDA regulation to Consumer Genetic Testing can be read at https://www.23andme.com/you/community/thread/3696/

  • Carolyn

    More paternalistic crap to make-jobs for government bureacrats and “experts.”
    The intelligent use of genetic information by “ordinary” (many who do understand genetics, statistics, epidemiology, biochemistry, etc.) seems antithetical to Big Brother.

    Follow the money, and it is easy to see that they want a piece of the action. No more government hacks – keep the astronomical federal budget from growing – keep your of choice to spend your money on more knowledge of your own body – tell them no, no, no . . . . Today is your last day to comment, send a message to the FDA.

  • Charles Bailey

    The struggle between knowledge and ignorance has been going on since humans invented language. It seems like a very sad day when ignorance wins out. It is most unfortunate when regulatory agencies make decisions based on fabricated “hypothetical” risks instead of the known “real” risks, especially those risks realized by cancer victims. I suspect there is plentty of evidence that ignorance is the most lethal.
    Charles Bailey

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