By Aaron Krol
July 16, 2015 | “Mr. Obama’s regulators are chilling innovation and investment,” fumed the Wall Street Journal. “The FDA bureaucrats think they know better than you how to handle your genetic information,” Ronald Bailey protested on the website of the libertarian magazine Reason. At Slate, Gary Marchant punched out every adjective on the soda lid: “a shortsighted, heavy-handed, double-standard act of paternalism… a death sentence for direct-to-consumer genetic testing… unjustified and unwarranted.”
More than a year and a half after the FDA told 23andMe to take its genetic health reports off the market, Elizabeth Mansfield, the agency’s Director of Personalized Medicine, still feels bruised by the pundits’ haymakers. “What a lot of people don’t understand,” she tells Bio-IT World, “is that FDA did not ban direct-to-consumer testing when it sent 23andMe a warning letter. It said, 23andMe, you in particular are out of compliance, and we’ve tried to work with you and it hasn’t worked out, so please stop selling your tests until you get into compliance.
“And that does not reflect any dissatisfactions with the model or anything like that.”
This February, the FDA made good on that assertion, giving 23andMe the go-ahead to test customers for a single factor: whether their children are at risk for inheriting a rare genetic disease called Bloom syndrome. The FDA-cleared test uses the same spit kit and genotyping panel 23andMe has always offered, albeit with more stringent labels and controls than customers may be used to. Mansfield thinks the process has cleared the air, and gives some assurance the FDA is not out to quash consumer genetics.
“I believe that [23andMe] have a much better understanding of what we’re looking for in terms of a regulatory submission,” she says. “We can move forward more easily with them.”
Read the full story at Bio-IT World.