FDA

Beyond 23andMe’s Shutdown: The Role of the FDA in the Future of Direct-to-Consumer Genetic Testing

Kyle Edwards, Uehiro Centre for Practical Ethics and The Ethox Centre, University of Oxford

Caroline Huang, The Ethox Centre, University of Oxford

On November 22, in a harshly worded “warning letter,” the US Food and Drug Administration (FDA) informed the direct-to-consumer genetic testing (DTC-GT) company 23andMe that it had 15 working days to discontinue marketing of its services. By December 5, 23andMe had canceled television, radio, and online advertising and stopped selling its $99 ‘spit kit’ DNA test online.

To put it mildly, the FDA and 23andMe have some communication issues to resolve. A working relationship dating back to 2008 appears to have soured after a six-month period of silence from 23andMe, prompting the warning letter and causing many observers to comment on the apparent stupidity and mystifying nature of 23andMe’s communication ”strategy.” While the FDA’s letter is quite clear that 23andMe must communicate better, particularly in reporting the accuracy of its tests, it is not at all clear on how the FDA plans to regulate companies like 23andMe after these accuracy results are in. Moreover, it hints strongly that some tests may be banned even if they are as accurate as the tests you could receive through a physician. 

Assuming 23andMe follows through on its promise to cooperate with the FDA, how exactly should these DTC-GT services be regulated to best serve the public?

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Shocking behavior: Government scare tactics, smoking, and public health

Coming to a mini-mart near you. The FDA has just approved nine very grisly looking warning labels—to be slapped on cigarette packs throughout the USA. But will they work to cut smoking … or will they backfire?

Here are some of the top reasons why these labels may not only fail to achieve the FDA’s desired outcome, but could actually do the opposite – leading to more smoking, not less. Continue reading

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