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….”
Ronald Bailey rejects that logic:
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 patients.
Razib Khan’s take:
23andMe has been moving aggressively to emphasize its medical, as opposed to genealogical, services over the past year. But this isn’t the story of one firm. This is the story of government response to very important structural shifts occurring in the medical delivery system of the United States. The government could potentially bankrupt 23andMe, but taking a step back that would still be like the RIAA managing to take down Napster. The information is coming, and if there’s one thing that can overpower state planning it is consumer demand. Unless the US government wants to ban their citizens from receiving their own genetic data they’re just putting off the inevitable outsourcing of various interpretation services. Engagement would probably be the better long term bet, but I don’t see that happening.
Alex Tabarrok weighs in:
The FDA wants to regulate genetic tests as a high-risk medical device that cannot be sold until and unless the FDA permits it be sold.
Moreover, the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the [Clinical Laboratory Improvement Amendments (CLIA)]) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases. Moreover, it means that firms like 23andMe will not be able to tell consumers about their own DNA but instead will only be allowed to offer a peek at the sections of code that the FDA has deemed it ok for consumers to see.
Alternatively, firms may be allowed to sequence a consumer’s genetic code and even report it to them but they will not be allowed to tell consumers what the letters mean. Here is why I think the FDA’s actions are unconstitutional. Reading an individual’s code is safe and effective. Interpreting the code and communicating opinions about it may or may not be safe–just like all communication–but it falls squarely under the First Amendment.