The FDA and 23andMe

By Razib Khan | November 25, 2013 12:30 pm

napFirst, download your 23andMe raw results now if you have them. If you don’t know what’s going on, the FDA has finally started to move aggressively against the firm. Unfortunately this is not surprising, as this was foreshadowed years ago. And, 23andMe has been moving aggressively to emphasize its medical, as opposed to genealogical, services over the past year. But this isn’t the story of one firm. This is the story of government response to very important structural shifts occurring in the medical delivery system of the United States. The government could potentially bankrupt 23andMe, but taking a step back that would still be like the RIAA managing to take down Napster. The information is coming, and if there’s one thing that can overpower state planning it is consumer demand. Unless the US government wants to ban their citizens from receiving their own genetic data they’re just putting off the inevitable outsourcing of various interpretation services. Engagement would probably be the better long term bet, but I don’t see that happening.

CATEGORIZED UNDER: Personal Genomics
MORE ABOUT: Personal genomics

Comments (11)

  1. Dmitry Pruss

    We are feeling FDA’s heavy hand in the conventional genetic testing too, as the fear of FDA’s involvement has brought to the halt the work to assign clinical significance to rare or newly discovered genes and genetic variants. Anticipation of clinical trial-like stringency of data collection and analysis turns rare genetic variation into “orphan mutations”. The information about them might be blocked from ever flowing from the testing labs to the patients.

  2. TheBrett

    I’m pretty sure they’ll settle with 23andMe at some point, simply because there is strong demand and a good medical purpose to be made for this type of testing. But it’s depressing to see them have such a heavy-handed reaction, and even more depressing that it seems to be aiming to try and turn this type of genetic testing into something only done through a doctor gatekeeper.

    Side-note, but please don’t perpetuate the “polish cavalry charge” myth. They never charged tanks with cavalry – they used the horses to travel around, which put them in the same category as every other combatant in World War 2 except for the US (who had the only fully mechanized supply chain).

  3. Neuroconservative

    Engagement would probably be the better long term bet, but I don’t see that happening.

    It sounds like the FDA has been attempting to engage 23&Me for years, but has been stonewalled by those charlatans for more than 3 years. Like Google, 23&Me has always operated as far over the ethical line as they could get away with. Do you really think the average consumer is even 1% as well informed as you are? This is why regulatory agencies are needed.

    • what? go to CVS and buy 400 cans of PowerUp and then come tell me that *knowing your own genome* is somehow worse.

    • Karch_Buttreau

      Can you explain yourself some more?

      When I see the FDA (and the FCC, SEC, …) my impression is “regulatory capture,” and the agencies are run by lobbyists. They’re certainly not operating in the interests of the general public.

      If the FDA gave a s— about anything, they would quell the abuse of antibiotics by farmers, but no….. that would cut profits at big pharma.

  4. Neuroconservative

    like the RIAA managing to take down Napster
    I believe this analogy is quite apposite, but I would interpret it slightly differently. It was neither futile nor Luddite for them to destroy Napster, which (IMHO) was based on pure thievery. The iTunes regime that followed (and persists) is far more equitable and just, even if it bears superficial resemblances to Napster (ie, digital distribution of content). Hopefully, a similar phoenix will arise from the ashes of the 23&Me debacle.

  5. Karch_Buttreau

    If I am reading this correctly, the warning letter says 15 days from Nov. 22, which is Dec. 7. That’s the possible D-day.

  6. Neuroconservative
  7. Anthony_A

    From Bloomberg’s article:

    “The FDA decided in 2010 that services claiming to evaluate a customer’s risk of disease must be cleared by regulators if the companies sell directly to consumers.”

    Will they be coming after people who sell scales and measuring tapes next?


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About Razib Khan

I have degrees in biology and biochemistry, a passion for genetics, history, and philosophy, and shrimp is my favorite food. In relation to nationality I'm a American Northwesterner, in politics I'm a reactionary, and as for religion I have none (I'm an atheist). If you want to know more, see the links at


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