

FDA Orders Genetic Testing Firm 23andMe to Halt Sales - wikiburner
http://money.cnn.com/2013/11/25/technology/fda-23andme/

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djjose
The crux of their troubles comes from this paragraph in the Warning Letter:
"However, even after these many interactions with 23andMe, we still do not
have any assurance that the firm has analytically or clinically validated the
PGS for its intended uses, which have expanded from the uses that the firm
identified in its submissions. In your letter dated January 9, 2013, you
stated that the firm is “completing the additional analytical and clinical
validations for the tests that have been submitted” and is “planning extensive
labeling studies that will take several months to complete.” Thus, months
after you submitted your 510(k)s and more than 5 years after you began
marketing, you still had not completed some of the studies and had not even
started other studies necessary to support a marketing submission for the PGS.
It is now eleven months later, and you have yet to provide FDA with any new
information about these tests."

The FDA, while being a pain in the rear at times, will actually work with you
to meet compliance. But you have to show work and be continually in touch with
them and show progress (and document everything according to your own
procedures, complying to regulations of course). You can't just say you're
working on compliance and then not follow through and show evidence. The issue
for 23andMe is the on-label use of the product "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." They
market the product this way. If you want to market your product as such, you
have to show proof to the FDA and receive approval to label the medical
product in this manner. It looks like 23andMe is either not working towards
compliance (and is misleading the FDA) or is doing a terrible job documenting
their work towards compliance and keeping the FDA abreast (my guess is this is
what's happening). That in itself will get you in trouble, but then expanding
your marketing for even more on-label use of the product - which hasn't been
submitted to the FDA apparently - while at the same time not having FDA
approval for the original use is just plain stupid.

~~~
dpe82
I used to work as a state legislative aid; one of my duties was helping
constituents work with state agencies on regulatory matters. I learned from
that experience most regulators (at least at the state level, I imagine
federal is similar) usually care much more about compliance than enforcement.
As long as you aren't doing something egregious and make a good faith effort
to work with them they'll often be pretty reasonable within the confines of
the law. However if you ignore them, they'll come down on you like a ton of
bricks.

It sounds like 23andMe has been ignoring them.

~~~
maratd
> As long as you aren't doing something egregious and make a good faith effort
> to work with them they'll often be pretty reasonable within the confines of
> the law. However if you ignore them, they'll come down on you like a ton of
> bricks.

This is how all government works, in general. There will always be multiple
opportunities to bring yourself into compliance, since it's in the
government's interest for you to comply.

Contrary to popular belief, the government would prefer compliance over a
fight.

23andMe on the other hand ... is either grossly incompetent or they're looking
for a fight.

FDA's regulatory oversight over this new industry is not established. If
23andMe wanted to challenge them in court, this would be the way to do it.
They need standing.

------
bcl
From the 23andme TOS:

"You should not change your health behaviors solely on the basis of
information from 23andMe. Make sure to discuss your Genetic Information with a
physician or other health care provider before you act upon the Genetic
Information resulting from 23andMe Services. For most common diseases, the
genes we know about are only responsible for a small fraction of the risk.
There may be unknown genes, environmental factors, or lifestyle choices that
are far more important predictors. If your data indicate that you are not at
elevated genetic risk for a particular disease or condition, you should not
feel that you are protected. The opposite is also true; if your data indicate
you are at an elevated genetic risk for a particular disease or condition, it
does not mean you will definitively develop the disease or condition. In
either case, if you have concerns or questions about what you learn through
23andMe, you should contact your physician or other health care provider."

[https://www.23andme.com/about/tos/](https://www.23andme.com/about/tos/)

~~~
Karunamon
This is what I don't get. It's not like this is hidden. The site is completely
upfront about what they are and what they do, what studies and results have
more confidence and which less.

Maybe I'm just a _little_ cynical here, but it seems the FDA would have better
things to do with their time. That in mind, I wonder what spurred this...

~~~
lylebarrere
This is much better than the other FDA story today where the FDA declared
walnuts a medicine because a manufacture made the factual statement "Omega-3
Fatty Acids found in walnuts have been shown to have health benefits."

[http://www.fda.gov/iceci/enforcementactions/warningletters/u...](http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm)

~~~
HaloZero
This actually makes sense. They're using marketing terminology to be say
"walnuts will do this, prevent this, and help you out with this".

If you want to market your product like a drug, you should go through the
regular inspection to make sure all your claims are satisfied, just like any
other drug.

~~~
mseebach
No, it doesn't make sense. The consequence is that no food marketing can make
(even truthful and not-misleading) claims about the healthiness of the
product. Carrots are healthier than Twinkies? Not unless they're a medicine.

~~~
biofox
The problem is in the claim that they can be used to treat disease.

Anyone can make false statements and there should be safeguards to protect
consumers, especially the sick and vulnerable.

Saying carrots are healthy is one thing, but that doesn't mean I should be
allowed to market them as a cure for some illness because "vitamins".

------
patrickmclaren
My comment from the same story on reddit.

For those protesting this decision, carefully read the following:

> However, even after these many interactions with 23andMe, we still do not
> have any assurance that the firm has analytically or clinically validated
> the PGS for its intended uses, which have expanded from the uses that the
> firm identified in its submissions. In your letter dated January 9, 2013,
> you stated that the firm is “completing the additional analytical and
> clinical validations for the tests that have been submitted” and is
> “planning extensive labeling studies that will take several months to
> complete.” Thus, months after you submitted your 510(k)s and more than 5
> years after you began marketing, you still had not completed some of the
> studies and had not even started other studies necessary to support a
> marketing submission for the PGS. It is now eleven months later, and you
> have yet to provide FDA with any new information about these tests. You have
> not worked with us toward de novo classification, did not provide the
> additional information we requested necessary to complete review of your
> 510(k)s, and FDA has not received any communication from 23andMe since May.
> Instead, we have become aware that you have initiated new marketing
> campaigns, including television commercials that, together with an
> increasing list of indications, show that you plan to expand the PGS’s uses
> and consumer base without obtaining marketing authorization from FDA.

It appears that 23andMe is and has been aware of this situation for quite some
time. In fact, the FDA has devoted significant time to aiding 23andMe in their
process to compliance:

> As part of our interactions with you, including more than 14 face-to-face
> and teleconference meetings, hundreds of email exchanges, and dozens of
> written communications, we provided you with specific feedback on study
> protocols and clinical and analytical validation requirements, discussed
> potential classifications and regulatory pathways (including reasonable
> submission timelines), provided statistical advice, and discussed potential
> risk mitigation strategies.

The FDA in fact proposed a relatively simple solution, which was related to
the labeling of the product.

> FDA has spent significant time evaluating the intended uses of the PGS to
> determine whether certain uses might be appropriately classified into class
> II, thus requiring only 510(k) clearance or de novo classification and not
> PMA approval, and we have proposed modifications to the device’s labeling
> that could mitigate risks and render certain intended uses appropriate for
> de novo classification.

Please keep in mind the scenarios in which the FDA attempts to avoid, in this
situation. Particularly, a layman could consider their 23andMe results to be
conclusive evidence for/against particular diseases and conditions, regardless
of the respective error bounds for the data, and take matters into their own
hands or simply prefer their results over the advice of medical professionals.
Sure, there are T&C on 23andMe which state that this product should not be
used in these purposes, this labeling is exactly what the FDA wants to
improve. Limitations of assurance or intended use cases for products of this
nature should be clearly labeled, and in a consistent manner. A startup
(although 23andMe could be considered to be well beyond that stage) should not
entrusted to make these decisions alone, and in fact, we do not have one such
independent entity within this space, it is a growing arena within which
multiple such entities are competing. It is not their business to care about
other use cases, it is their business to stay in business.

A particular paragraph on 23andMe's homepage says "Understand your genetic
health risks. Change what you can, manage what you can't." I do see many
individuals in the Nootropics/Quantified Self community interpreting their own
results and indeed taking matters into their own hands. Okay, so perhaps these
individuals may be of above average intelligence and are capable of behaving
rationally, but this desire to improve oneself is not limited to our circle.
Believe it or not, most of the population would love to improve in one aspect
or another. We should be very careful in what 'gifts' we present to society,
especially gifts of this nature.

------
shubb
The problem with 23andmMe is that genetics can't currently tell us much about
our risk of developing common genetic diseases.

Some diseases are caused by a single gene. These are rare because people with
a dominant copy of that gene are less likely to reproduce, so they are mostly
deselected. Many of these monogenic diseases have a pretty major effect. You
know if you have them (and probably died in childhood). Pre-natal genetic
counseling is where finding these is useful.

Most of the diseases 23andMe talks about are caused by multiple genes (in
combination with the environment). The interactions between these genes are
often really complicated, and typically the number of genes involved is huge
(and the actual contribution of each gene to risk is very small). This has
made investigation a nightmare - even the most understood genetic diseases, we
only know about say 10-20% of the genes that make up the genetic part of the
risk, which may only be 40% of the total risk.

So 23andMe sees you have 1 of the 100 genes that we identified as contributing
to a disease. That means you have 1% of 20% of 40%, which is really nothing to
get excited about.

I know 23andMe tries to communicate this, but they are also trying to run a
buisness. If they stood up and said 'yeah, we can do some tests, and they
really won't tell you anything worth knowing', they would get no press
coverage. But anything else is... carefully not lying, rather than being
honest.

I read other commenters here, who say things like 'Well it's a nice compliment
to getting a blood test', and get the feeling they think these tests mean
shit.

------
taspeotis
Previous discussion
[https://news.ycombinator.com/item?id=6794122](https://news.ycombinator.com/item?id=6794122)

    
    
        317 points by jefffoster 14 hours ago | flag | cached | share | 377 comments

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DigitalSea
Completely understandable and it's a fair point people might undergo
unnecessary surgery as a result of a false positive (like having breast tissue
removed preemptively after false positives for chances of contracting breast
cancer). 23andMe is a nice idea, but you can't beat an old fashioned regular
trip to the doctor and blood test to check for these things.

~~~
gkoberger
Think about the opposite, though -- most people don't get tested for anything,
especially weird/uncommon conditions. Tests like 23andme aren't something your
local doctor does every checkup.

For $100, people who otherwise would have been clueless know if there's
something they should ask their doctor about. In this case, I think some false
positives are better than ignorance.

Worst case, you think "oh no, I'm predisposed to ___!" for a few days until
you make it to a doctor who can tell you for sure.

It's fair to say 23andme has saved far more lives than it's hurt.

~~~
felipe
> Tests like 23andme aren't something your local doctor does every checkup.

Fair enough. So why not let FDA go through their process, do their
investigation, and once approved people could safely rely on 23andme.

~~~
coryrc
We could write something untruthful or harmful in the newspaper (maybe about
acai berry weight loss).

So why not let the government go through a process, investigate whether what
we write is conducive to the public good, and once approved it can be safely
published.

------
dangero
Has 23andMe told their side of the story yet? The FDA's press release made it
sound like 23andMe was very negligent, but there has to be more to it than
that. I can't imagine a company just ignoring the FDA's requests.

~~~
fjarlq
They posted this to Facebook:

 _Hi everyone, Many of you have seen and been asking about this morning 's
news.

Here's the statement we've issued to the media: "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."

We'll continue to keep you updated here as we know more. Thanks for all the
messages of support!_

[https://www.facebook.com/23andMe/posts/10152374363517802](https://www.facebook.com/23andMe/posts/10152374363517802)

------
rossjudson
When I read the FDA press release, it states that 23andMe must cease
_marketing_ their product. I don't see where it says that they must stop
selling it. If I'm right about that, they're free to continue selling the
product but have to stop their public statements about it, until the FDA
grants them leave to do so.

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snitko
FDA as always sticking their nose into something they shouldn't. Let the
people decide whether they want to use this particular service or not. People
ought to be free to choose. Otherwise it's not consumer protection, it's
consumer dictatorship.

~~~
thelambentonion
This really looks like the FDA sticking their nose into something they
_should_. 23andMe is making false claims about the efficacy of their test in
their marketing material and the FDA isn't okay with that. They're not even
ordering 23andMe to stop testing, just to stop marketing their service as
something it isn't.

------
Michael_Murray
Of course this happens the week after I submit my sample.... ;-)

------
jacoblyles
I'd rather see them shut down the FDA than 23andMe

~~~
cscurmudgeon
I am not a big fan of possible snake oil even if it comes in hipster startup
form.

~~~
snitko
Great, don't use it then. Why do you believe you have the right to tell other
people what to buy for their money?

~~~
cscurmudgeon
>> Why do you believe you have the right to tell other people what to buy for
their money?

I am not doing that. The FDA is doing that. That is their job. If you disagree
with that, you should also be okay with charlatans selling snake oil.

~~~
snitko
You are paying for it with your tax money, therefore you are doing it. I'm not
okay with selling snake oil, but I think it is wrong to prevent other people
from buying it. It's okay to inform them it's a bad idea to buy certain things
- it's dictatorship to prevent them from doing so. If you can't convince
somebody, it's your problem, not that person's problem. FDA doesn't convince,
it just comes and shuts you down or doesn't allow you on the market.

Besides, where is FDA when charlatans sell homeopathic medicine? Show me a
little consistency here.

~~~
cscurmudgeon
I never said that the FDA is perfect or covers all bad cases. Just because a
few bad apples can escape the law now, in letter, does not mean that we should
not have regulation. Medical regulation is far from dictatorship. It is
orthogonal to it.

Just because a govt. prevents from doing X, does not mean by default that the
govt. is a dictatorship. X has to be something basic like the right to live or
the right to free speech. The FDA is not brutishly shutting down 23andme. They
seem to have reasonably tried to work with 23andme. But the startup has been
stubborn.

~~~
snitko
You don't get my point. I'm questioning the existence of the FDA itself.
What's your excuse for not letting each individual decide for himself what he
wants to spend his money on? It's his money after all. He didn't ask you to
pay for what he wants. What is your problem with that?

~~~
hackinthebochs
Massive information asymmetry means it is highly likely that people will be
taken advantage of. The FDA balances the information asymmetry of the public
and a product by defining a process that allows companies to make certain
claims.

~~~
snitko
This doesn't answer the question of why FDA bans products and services instead
of simply informing consumers of possible dangers and letting them decide for
themselves. Government has the largest resources to reach out to people, so
any message it would want to communicate, it could.

If the government really cared about consumers, it would go after homeopathy
dealers, religious leaders and other charlatans. Never gonna happen. Why do
you think that is? Why homeopathy existed for such a long time and never had
any problems with authorities, but a startup that actually provides some value
to people, suddenly is a threat that needs to be shut down?

~~~
hackinthebochs
>why FDA bans products and services instead of simply informing consumers of
possible dangers

Because that costs money that they shouldn't have to spend. If a company is
marketing a product as X, why should the FDA have to counter with marketing
that says product is actually ~X, rather than simply stop the marketing as X?

I'm sure homeopathy dealers aren't allowed to make medical claims. Perhaps the
FDA doesn't go after them as stringently as you might like, but lets not
pretend that they have free reign.

~~~
snitko
So use force instead of convincing people, because it's easier and cheaper.

My problem with any regulatory agency is that it can't claim to work on behalf
its clients. Why? Because funding comes from taxes and taxation is not
voluntary. No one asks people whether they want to pay taxes or not. They
still have to or they will be fined even more or will go to jail. Thus, FDA
lacks basic market mechanisms that could check such a consumer protection firm
in check. If a group of people feel dissatisfaction with their work - fuck
them, who cares? They're still getting their funding.

Homeopathy dealers are having a great time and make tons of money. They may
not make medical claims, but that doesn't stop them from hurting a lot of
people by offering something those people believe is a cure. Let's not pretend
government does anything to stop it, really.

~~~
hackinthebochs
Personally I feel the libertarian premise is absurd so anything that follows,
however rational, is nonsense to me. I don't think we can have a productive
discussion.

