The United States Food and Drug Administration has gone way over the top by
banning genetic testing by 23andme.
The letter from the FDA is posted online at
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm
However, the FDA has far exceeded its legal authority. The letter from the
FDA says, "23andMe must immediately discontinue marketing the PGS until
such time as it receives FDA marketing authorization for the device.”
However, 23andme does not market a "device". It is a simple test tube
commonly available at any medical supply or high school science supply
store. One simply spits in the tube, seals it with a stopper and mails it
in. The mailing box with a bar code on it simply prevents it from getting
mixed up with the many thousands of other similar test tubes mailed being
in. There is no possible health risk to the procedure. I do not see how
the FDA has jurisdiction to ban it.
The FDA claims that it has jurisdiction to do so because it has the
authority to ban any device used in the "diagnosis of disease or other
conditions or in the cure, mitigation, treatment, or prevention of
disease". However, 23andme does not diagnose or treat any disease. What it
does instead is test millions of people who have sent in their saliva
samples and then tries to find which DNA types are more likely to get which
diseases. It does not tell you weather you have the disease or not. It just
tells you to be on the lookout if your particular DNA type makes you more
likely than average to get this disease.
It has long been known that certain racial or ethnic groups are more likely
than others to get certain diseases. Anybody can think of examples of this.
Does the FDA propose all racial profiling for certain kinds of diseases?
More than that, the FDA says that there needs to be more research before
linking certain DNA types to certain diseases. However, 23andme is doing
that very research in the only way it can be done. 23andme is in the
process of collecting DNA samples from millions of people. Only by
sequencing their DNA can it be determined which DNA types are more prone to
which diseases.Does the FDA propose to ban all genetic testing?
Most subscribers to 23andme use the test results for an entirely different
purpose, which is to find out who their relatives and ancestors are.
A letter to Scientific American says " few techno-libertarians are up in
arms<http://reason.com/blog/2013/11/25/fda-shuts-down-23andme-outrageously-bann>over
the FDA’s letter
<http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm>warning
the genetics company 23andMe to stop selling its personalized genome
services kit." However, the Libertarian Party has not taken up this issue.
It should do so.
Sam Sloan