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The FDA Orders 23andMe to Stop Marketing Medical Tests

23andMeSo by now you’ve no doubt heard that on November 22, 2013, the Direct-to-Consumer genetics testing company 23andMe received a uncharacteristically biting letter from the Food and Drug Administration (“FDA”), a federal agency that protects public health by monitoring and regulating various products such as food, medicine, and supplements.

In the letter, the FDA expresses its belief that the 23andMe Personal Genome Service (“PGS”) is a medical product because “it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.”  Accordingly, the FDA concludes, the PGS requires “premarket approval or de novo classification” by the FDA.

Most surprisingly, however, the FDA indicates that although there has been “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications,” the FDA has not heard from 23andMe since May, 2013, six months ago.

The FDA ended the letter ordering 23andMe to stop marketing the PGS until it receives FDA authorization, and 23andMe has 15 days to notify the FDA in writing of the steps it has taken to remedy the issues in the letter.

23andMe’s Response – So Far

23andMe responded first with a statement, and then with a blog post at the Spittoon (“An Update Regarding The FDA’s Letter to 23andMe”).  In these responses, 23andMe indicated that it believes working with the FDA is important, and that they will continue to do so.

Medical – NOT Genealogical

This applies ONLY to the medical aspects of the 23andMe PGS, and NOT to the genealogical aspect. Any regulation of DTC genetic genealogy tests (which the ASHG and other entities have stated they are no longer interested in doing) would have to come from new legislation or some other federal entity, as the FDA would have no jurisdiction over purely genealogical testing.

It’s possible that 23andMe may split the PGS into medical and genealogical aspects, or temporarily block access to the medical information, at least until the FDA is appeased.  In any event, there’s every reason in the world for 23andMe to keep at least its genealogical tools available and for sale, and that’s what I’m predicting they will do.

Questions Remain

  1. Why did 23andMe stop communicating with the FDA?

I don’t know.  This is the question everyone is asking.  Regardless of whether you believe 23andMe’s PGS should be regulated, the lack of communication with the FDA is frustrating.  I note that we’ve only heard one side of the story here, and it’s possible there’s some explanation for a 6-month delay.  For example, 23andMe’s General Counsel Ashley Gould left the company in July 2013 (see her LinkedIn profile, for example), which could have delayed a response.  It’s also possible, although unlikely, that this is an intentional tactic to force a confrontational resolution to the issue.

  1. How Will it Affect my Data?

It won’t (at least not the genealogical data).  This letter from the FDA does not signal the end for 23andMe, as some have predicted.  As I said above, I doubt that 23andMe will block access to their genealogical tools for current customers, and I predict that they will continue to market the PGS in some form while they work with the FDA, even if it’s purely a genealogical test (maybe including the “traits” which are arguably not medical).  It wouldn’t change the test in any way, all the same SNPs will still be tested and available for download, and they could “reactivate” the medical side interpretations depending on how the FDA issues are resolved.

My Prediction: If you’re only interested in the genealogical tools, you likely won’t be affected by the FDA’s letter, other than a slowing in new matches if it negatively impacts sales. On the flip side, sometimes even negative publicity turns out to be good publicity.

  1. Should 23andMe be Regulated?

Maybe, a little.  To the extent that the FDA wants to ensure that the SNPs and interpretations are accurate and provided to customers in an understandable way, I’m fine with limited regulation.  While consumers have proven to be valuable self-regulators of 23andMe, pointing out errors and bugs, there could be future snake oil companies that are less than reputable and not as open as 23andMe has been.  Regulations would help ensure that testing is done only in reputable labs, and interpretations are accurate and robust.

However, to the extent the FDA wants to set up any barrier between me and my genetic information, I am vehemently opposed.  I have a fundamental human right to my genetic information and the interpretation of that information, and setting up any paywall – including a physician or geneticist – is an unethical violation of that right.  Although genetic information has proven to be far less predictive and actionable than almost everyone expected, it has the potential to benefit thousands or millions of people.  Overreaching regulation by the FDA would only delay that benefit.

For More Information

If nothing good comes out of this situation, at least it has sparked a great deal of debate and discussion.  Here are links to other geneablogger articles on the issue:

And here is an extensive round-up of some of the best links discussing the FDA’s letter, both pro and con, in no particular order (these articles provide some insight rather than just re-hashing the letter and 23andMe’s response):

What About You?

I want to know what you think. Leave a comment below!

Blaine Bettinger

Intellectual property attorney, genealogist, and author of The Genetic Genealogist since 2007

15 Comments

  1. 23andME provides a valuable service at a price many can afford. I wish this testing would have been offered YEARS ago. I feel 23andME is very clear and cautionary on how an individual uses their information. It frustrating that the government would intervene but I speculate that there are other drivers – i.e. medical providers or drug companies – who may feel threatened by individuals having more informed data on their own personal health. Even though there is a lot of talk about lifestyle changes, somehow having DNA information makes the lifestyle changes idea more real. A lifestyle change could impact the need for medication which impacts medical providers and drug companies.

    • There are certainly a lot of drivers here. I believe there is a way to make everyone happy, including both the FDA and customers, and I hope that 23andMe can find that happy medium.

  2. I am a layman in all of this. I have read the FDA letter. But the part I don’t get with the FDA is there lack of recognition of the statement that appears on 23andMe. Under Health Risks, in my account, is a statement that reads, “The genotyping services of 23andMe are performed in LabCorp’s CLIA-certified laboratory. The tests have not been cleared or approved by the FDA but have been analytically validated according to CLIA standards. The information on this page is intended for research and educational purposes only, and is not for diagnostic use. ” I am only using it for my self-education and for my own family research. I’m not playing doctor.

    • Many would agree with you Paul. As I suggested, I think there may be a role for the FDA here, but time will tell whether the FDA envisions a bigger role that many of us would be comfortable with!

  3. I tested with FTdna, 67 markers. No problem extracting dna. R1b1a2 (M-269).
    I tested with Ancestry.com (autosomal). 99% European. Recently received revised results..Scandinavian first was 56% and secondly 13%….
    I then submitted my saliva to 23andMe on 10-17-13. On Sunday 11-24-13 I was notified by email that they could not extract adequate DNA from my sample and were shipping me a new kit. The FDA article (11-22-13) was first observed on “Newbie” mailing list.
    I contacted 23andMe by email and then called their 800 number and spoke with customer service rep. I was assured that the reason for reanalysis had nothing to do with the FDA letter.
    I then requested they overnight the kit to me via UPS at my expense. I received a reply advising that the kit was “in fulfillment” and could not be sent overnight.
    What would you like to bet (and I am not a betting man) that I do not receive the “medical results” when I resubmit the saliva sample?

    • It’s certainly possible Richard! We don’t know yet how they’re going to handle the medical side of testing, but I’m expecting that there will at least be a temporary interruption.

  4. The FDA has no business regulating what 23andMe does. 23andMe has been in business 5 years. Why did the FDA wait until 9 months ago to bring this up? OOoohhh wait that’s about the time Anne filed for divorce from Obama’s buddy!

    • The FDA has been communicating with 23andMe for a few years now trying to work with them to figure this out. We’re not sure why things recently changed, other than a lack of communication from 23andMe.

  5. You will find a much better discussion of the issues on Judy Russell’s blog, The Legal Genealogist. This issue has to do with marketing claims and with medical recommendations made by 23andMe. And it did not start nine months ago.

    I completely agree with FDA regulation based on the fact that 23andMe has set itself up as offering insight into medical issues rather than a genealogical service and has used that tract to distinguish itself from FTDNA and Ancestry. It wants to attract a different demographic and it has. This is not about the right to your DNA – it is about the right of a company making unsupported claims.
    For those wanting more information check out Judy’s blog from 11-26.

    • I agree, Judy has a great blog post about the issue (and I even linked to it in my post!), and her conclusions are almost exactly in line with mine. It’s not about “unsupported” claims at all – every trait and condition at 23andMe is supported by a summary of and links to the basic scientific research (i.e., peer-reviewed scientific publications) that was used. You’ll be unable to point me to any reputable accusation of “unsupported” claims. The FDA wants to ensure the accuracy of the test results, and the accuracy of the interpretations.

  6. Re the link to “Here’s What Happens When You Share Your 23andMe Results With A Doctor” at Seattle PI
    I too have had reactions from several of my doctors that demonstrated disinterest and ignorance about my 23 and Me data. However, my endocrinologist was really excited and asked to see my results. I recently provided him my 23 and Me password so he could access and study the site at his leisure. He is definitely the exception rather than the rule among my many doctors.

    I am also interested in what the FDA plans to do about the Personal Genome Project? http://www.personalgenomes.org/ I have applied to that too.

    • It’s refreshing to hear of physicians who are actively engaging in personal genomics. I’ve been involved in a course at a local medical school that educations medical students in personal genomics issues and platforms, and it has been a very valuable experience.

  7. I am a licensed clinical laboratory scientist as well as a user of 23&Me’s medical information. It is unfortunate that 23&Me did not continue its discussion with the FDA after their counsel left the company. I find 23&Me’s statistical medical information valuable, even though I personally understand the limitations. I have two confirmed genetic mutations that have caused medical issues. One of them was perfectly detected by the SNP technology; the other one couldn’t be reported (due to legal issues from Myriad Genetics). This latter one is called a false negative, something present which is not detected. 23&Me does discuss false negatives in their tutorial sum but I would feel better if they just didn’t report anything.

    Here is a quote from the San Diego Union Tribune (Gary Robbins, author) from Nov. 25, 2013 with regards to the 23&Me vs. FDA situation:
    “The FDA’s action drew quick and blunt reaction from several prominent San Diego-area scientists, some of whom have supported 23andMe’s vision to make direct-to-consumer genetics an accepted way for people to watch their own health. The strongest words came from Eric Topol, the La Jolla cardiologist-geneticist who heads the Scripps Translational Science Institute in La Jolla.

    “We have published extensively on the benefit of direct to consumer genomic testing,” said Topol, who has taken the 23andMe test. “I think it’s unfortunate and a big mistake for FDA to take 23andMe off the market. The data it provides is indeed reliable, even though it only represents a genomic ‘starter kit’ and is a fraction of information that can be derived from whole genome sequencing.”

    “The data it returns direct to consumers provides useful information on drug interactions specific to the individual, carrier state for couples planing on conceiving, ancestry data, and susceptibility information for many diseases. Hopefully the company will work with the FDA to get back in business very soon.”

  8. I’m extremely disappointed – and alarmed – over the flap between 23andMe and the FDA. It seems that as soon as there is something beneficial to the public which is not regulated, one arm of the government just can’t wait to step in and impose restrictions. I recently submitted my sample to 23andMe which has been received by their lab and am awaiting results. The reason I am partaking in this study has nothing at all to do with seeking out possible medical conditions. Since I know my family’s medical history pretty well back to all of my great grandparents, I’m aware of at least some of the major problems that I could encounter. I’m in my early 60’s now and in very good health. If I do discover negative medical information through 23andMe, I’m certainly not going to hysterically run to my doctor. Instead, I’m very much more interested in all those ancient DNA components that make me what I am today. I’d say that the majority of 23andMe subscribers are, too. Shame on you, FDA!

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