FDA Shuts Down 23andMe: Outrageously Banning Consumer Access to Personal Genome Information:

23andMeFor a couple of years, I have
been warning all my friends and colleagues to purchase $99 personal
genome testing from 23andMe before the Feds banned it. Well, now
the Food and Drug Administration has banned it sending the genome
testing company a
warning letter

The Food and Drug Administration (FDA) is sending you this
letter because you are marketing the 23andMe Saliva Collection Kit
and Personal Genome Service (PGS) without marketing clearance or
approval in violation of the Federal Food, Drug and Cosmetic Act
(the FD&C Act). 

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. For example,
your company’s website at www.23andme.com/health (most recently
viewed on November 6, 2013) markets the PGS for providing “health
reports on 254 diseases and conditions,” including categories such
as “carrier status,” “health risks,” and “drug response,” and
specifically as a “first step in prevention” that enables users to
“take steps toward mitigating serious diseases” such as diabetes,
coronary heart disease, and breast cancer. Most of the
intended uses for PGS listed on your website, a list that has grown
over time, are medical device uses under section 201(h) of the
FD&C Act. Most of these uses have not been classified and
thus require premarket approval or de novo classification, as FDA
has explained to you on numerous occasions.

The FDA says it is concerned that consumers would misunderstand
genetic marker information and self treat. For example, the agency
cites the company for testing for versions of the BRCA gene that
confers higher risk of breast cancer worrying that women might get
a false positive test leading “a patient to undergo prophylactic
surgery, chemoprevention, intensive screening, or other
morbidity-inducing actions….”

What the test results would actually lead patients to do is to
get another test and to talk with their physicians. The FDA also
cites the genotype results that indicate the sensitivity of
patients to the blood-thinning medication warfarin. Again, such
results would be used by patients to talk with their doctors about
their treatment regimens should the time come that they need to
take the drug. In fact, in 2010 the FDA actually updated its rules
to recommend
genetic testing
to set the proper warfarin dosages for

It is notable that the FDA cites not one example of a patient
being harmed through the use of 23andMe’s genotype screening test.
Nevertheless the agency orders that…

…23andMe must immediately discontinue marketing the PGS
(Personal Genome Service) until such time as it receives FDA
marketing authorization for the device.

The FDA bureaucrats think that they know better than you how to
handle your genetic information. This is outrageous.

For more background, see my 2011 Reason article on my
own genetic testing experience
and go to SNPedia here for even
more information on my genetic flaws.

H/T Mike Riggs and Andrew Mayne.

from Hit & Run http://reason.com/blog/2013/11/25/fda-shuts-down-23andme-outrageously-bann

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