Several days ago
23andMe finally reacted to the
FDA warning letter and, at least temporarily,
suspended its DNA test and health analysis. While the company is still sticking to its business model.
Wojcicki and her team believe in the power that personal genomic information can bring both the individual and the health-care industry when that data are pooled for research.
it also has been slapped with the
$5 Million lawsuit for misleading advertisement.
A spokeswoman for Mountain View, Calif.-based 23andMe said in a statement Tuesday that it would not comment on legal matters. The company said it stopped advertisements via TV, radio and online last week. But the company's test kit is still prominently displayed on its Web site. When asked if the product is still being sold the spokeswoman declined to provide further comment.
SCI-TECH Today.com 23andMe Faces Class Action Lawsuit in California By Matthew Perrone
The FDA letter and 23andMe recent decision to halt its services caused according to the media consumer backlash and additional explanation from FDA.
In fact, Tech Freedom, a post-partisan tech policy think tank/lobbying organization based in Washington, DC, around December 2 started petition on Change.org that has been signed by now by more than 5,000 people. Tech Freedom was launched in January 2011 with the libertarian mission
to unleash the progress of technology that improves the human condition and expands individual capacity to choose. We believe human ingenuity is the ultimate resource, but that it can flourish only in a policy environment that recognizes the central importance of individual rights, individual as well as corporate responsibility, user empowerment, entrepreneurship, and dynamic technological change.
The technology is a powerful tool that if improperly used can cause unintended consequences as it happened with the overuse and abuse of internal combustion, antibiotics, nuclear power and even Internet that have being turned into "spy on all" tool. For centuries physicians recognized that and were guided by the principal
Primum Non Nocere -
First Do No Harm. This principal served humanity well and saved countless lives, and because of it FDA makes sure that all new medications, devices and technologies are thoroughly tested before they are used for diagnostic or medicinal purposes. DNA technology is extremely powerful, but still is a young technology in its infancy. As a society we are not ready yet to turn it into "over the counter" consumer friendly technology tool. It could be as much harmful and dangerous in malicious and amateur hands as lifesaving and useful in the hands of scientists and physicians.
FDA acted with great patience and care working with
23andMe company for years. The warning letter was neither abuse of the power nor otherwise careless act that caused any damages to the public. The "public" outcry provoked by TechFreedom petition is not by any means justified. There are plenty of labs that still providing DNA testing to the public and suspension of
23andMe did not cause any shortages of testing services or spike of test prices. FDA did not "shutdown"
23andMe and did not irreparably damage its business. It is totally up to
23andMe to provide FDA with necessary information and meet FDA requirements. Hundreds or even thousands of companies comply with FDA legal requirements and regulation and do business serving millions of consumers.
That is why we
created petition supporting FDA actions regarding
23andMe and urging you to consider signing it and help spreading the word and ask your friends to do likewise.