You don't need to be an expert in the regulations covering medical tests to know that the Food and Drug Administration has just about had it with Silicon Valley's 23andMe.
The agency told the seller of a personalized genomic test to knock it off in a sternly worded warning released Monday. The 23andMe spit kit and personal genome service, or PGS, are being marketed without FDA's blessing, the letter says. "Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device," the agency concludes.
The company's $99 test promises to tell you if your kids are at risk for a range of inherited health conditions, your own genetic health risks and even how you're likely to respond to certain drugs.
That last claim really peeved FDA. People's genes can affect how they'll respond to blood thinners and cancer drugs, such as fluorouracil. But how accurate are the test's results? And even if they are spot on, what if someone taking one of the drugs stopped or adjusted the dose after looking at the test results and before consulting a doctor? Changes like those pose a serious risk of injury or death, the agency says.
23andMe has filed paperwork with the FDA about the tests, but evidently not enough to satisfy the agency.
What does the company say? Spokeswoman Kendra Cassillo emailed:
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.
The company also posted its statement on Facebook. And commenters quickly weighed in, most of them in strong support of the 23andMe. "Pathetic," wrote Grant Williams. "The FDA has no right to tell me what I can learn about my own genetic information."
But Chris van Loeben Sels responded to Williams on Facebook:
Actually, the FDA's concerns are quite reasonable. If you're going to claim these medical benefits, if people are going to take the results to doctors, if we're going to rely on them for medical action, they should be licensed for accuracy just like an x-ray machine or anything else. I'm really surprised to hear that the FDA has been talking to 23andMe for years with such little progress. For 23andMe to launch TV ads knowing that the FDA was examining their marketing claims is even more surprising. To keep selling the kits online with no reference to the FDA action on the site — and not even changing the at-issue claims — is astounding.
Since 2009, the letter says, the FDA has had "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" in which the agency has explained what it wanted and given 23andMe feedback on its work.
The final FDA gripes are about a bunch of new ads this year that expanded the company's marketing claims when there had been no progress on getting the old ones squared away.
It's pretty clear that in the FDA's view, 23andMe has run out of time to show that its tests are up to snuff. "FDA is concerned about the public health consequences of inaccurate results," the agency wrote, and it wants to "ensure that the tests work."
The company has 15 days to respond to FDA's letter.