Under pressure from the FDA, 23andMe says it will stop selling health-related genetic test analysis until it has resolved its dispute with the federal regulatory agency.
"We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives," says Anne Wojcicki, co-founder and CEO of 23andMe. "Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test."
Experts point out that the Mountain View, CA–based company may have garnered the FDA's displeasure with over-marketing. But the episode might also spur some regulatory updates that are needed as new, disruptive technologies hit the market.
The FDA's move is but another sign that the regulator is increasingly concerned about the proliferation of relatively cheap genetic tests on the market.
The agency in 2010 informed 23andMe and four other genetic test makers that their products needed federal approval.
Three years later, FDA official Alberto Gutierrez tells 23andMe in a warning letter dated Nov. 22 that it did not work with the agency toward de novo classification and did not provide additional information requested to review a 510(k). The company has not even communicated with the FDA since May, according to Gutierrez.
"Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS's uses and consumer base without obtaining marketing authorization from FDA," Gutierrez says.
It had been possible to order a 23andMe saliva collection kit online, mail it back in, and get back a DNA analysis involving a whole host of factors related to health predisposition.
For now, 23andMe will continue to provide both ancestry-related information and raw genetic data without interpretation to customers, and will continue to conduct health-related research with its overall database.
The Washington Post's Ezra Klein thinks 23andMe mismanaged its relationship with the FDA, but he also suspects the disagreement and others that pop up out of Silicon Valley could spark needed regulatory changes:
"There are a slew of companies in Silicon Valley -- Uber, Lyft and AirBnB are other high-profile examples -- that are operating at the outer edge of the regulatory regime. Their business models are frequently direct challenges to prevailing rules. When confronted by regulatory agencies, they often choose to fight rather than fold. The arrogance driving such behavior can be off-putting, but public collisions with laws that, in many cases, should be updated and reworked can lead to overdue reforms."
