So 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.
- 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.
- 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.
- 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:
- “Fooling with FDA” at The Legal Genealogist
- “FDA Orders 23andMe to Discontinue Testing” at DNAeXplained
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):
- “No DNA Testing For You, Thanks to the FDA” at The Daily Beast
- “The FDA Should Leave 23andMe Alone” at The Washington Post (blog)
- “The FDA’s Battle With 23andMe Won’t Mean Anything in the Long Run” at Slate
- “23andStupid: Is 23andMe Self-Destructing” at Forbes
- “FDA orders 23andMe to shut down home genome test” at Overlawyered
- “23andMe ordered to halt sales of DNA tests” at Nature
- “The FDA Drops an Anvil on 23andMe – Now What?” at The Center for Law and Biosciences
- “FDA Overreach” at The Volokh Conspiracy
- “Should 23andMe be Regulated?” at Seqonomics
- “Some Thoughts on the FDA Action Against 23andMe.com” at Mike the Mad Biologist
- “In Taking Aim at 23andMe, Regulators Missed the Mark” at Entrepreneur
- “Stopping 23andMe will only delay the revolution medicine needs” at The Hindu
- “FDA vs. 23andMe: How do we want genetic testing to be regulated?” at it is NOT junk
- “23 Skidoo – Genomes, Gamesmanship and the First Amendment” at The National Law Review
- “23andMe: Victim of an Overboard FDA Crackdown, or Provocateur?” at Xconomy
- “Here’s What Happens When You Share Your 23andMe Results With A Doctor” at Seattle PI
- “Why 23andMe is Not for Me — Yet” at DNA Science Blog
- “The FDA Could Set Personal Genetics Rights Back Decades” at Slate
- “Why the FDA is targeting Google-backed 23andMe: Unnecessary MRIs, mastectomies” at VentureBeat
What About You?
I want to know what you think. Leave a comment below!