Tuesday, December 17, 2013

Misinformed Outrage Over FDA Letter to 23andMe

Tonight, I read an excellent post on the website KevinMD* supporting the FDA's recent action against 23andME. 23andME offers broad genetic testing to the public.** The comments that followed raged that it was ridiculous for the FDA to regulate the tests as a 'device' since the tests are not a device and that the FDA was interfering with patient freedom by outlawing these tests. Not so fast. As a doctor and occasional lawyer, let me explain why the commenters are thoroughly misguided.

First, 23andMe can still market the tests.** They have simply barred the company from making bogus interpretations and unsubstantiated claims about what the tests can do. For why that matters, see the post on KevinMD.*

Second, the tests are a 'device' in this context. Sometimes, lawmakers and regulators use common words as shorthand for specialized concepts. The shorthand is spelled out within a particular law or regulation for use in that context only. Common usage is not relevant. As the FDA says in its letter, and as 23andMe surely knew, "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."***

23andMe claimed that their tests were the ' “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer.' The FDA offered them the opportunity to substantiate these claims. They ignored the offer. Theirs is exactly the sort of behavior the FDA was founded to regulate.

So please, disagree with the law if you like, but read before you rage.