Monday 2 December 2013

23andMe halts advertising amid FDA demands

People can still buy the genetic-testing startup's popular at-home testing kits, but they won't see any marketing for these products.

 
While 23andMe has forged on despite the Food and Drug Administration's order to halt sales, the company is now saying it has stopped marketing its products as a result of the kerfuffle.
According to Reuters, the Google-backed genetic-testing startup has halted its TV, radio, and online ads for its popular at-home testing kits.
23andMe was issued an FDA warning letter two weeks ago. The government agency demanded the company stop selling its at-home testing kits "immediately" because they required regulatory clearance and were supposedly being sold in violation of the Food, Drug, and Cosmetic Act.
In response, 23andMe issued a brief statement saying the company's relationship with the FDA is "extremely important to us and we are committed to fully engaging with them to address their concerns"
In the meantime, however, 23andMe has continued to sell its at-home testing kits as it works to come in compliance with the FDA's requests.

In a blog post last week, the company's founder Anne Wojcicki wrote that the company was working to convince the FDA of the "quality of our data" and that it was in dialog with the agency -- albeit somewhat behind in responding to its requests. "This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future," Wojcicki wrote. "It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public's safety."

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