11 ms·

Am I the only one this seems completely reasonable to? There are probably people who take action over the results they get from the service and if the results a

Am I the only one this seems completely reasonable to? There are probably people who take action over the results they get from the service and if the results are incorrect the actions could have negative impact on their health. Therefore the service should have to prove the results are accurate before advertising it as a first step in prevention.

wissler 13y ago
As if the FDA were qualified to make such determinations.
Glyptodon 13y ago
Probably. I think most people view their service as fun thing that comes back with results that, if revealing of a concern, would cause you to seek proper and more detailed testing from a real medical practitioner. It's not like a physician prescribes a 23 & me writeup.
- rayiner 13y ago
  > I think most people view their service as fun thing that comes back with results that, if revealing of a concern Take this thought, and replace "some people" with "my mom" and see if it still results in the same conclusion.
  - Glyptodon 13y ago
    Yep. I'm pretty sure she'd view it along the same lines as one of those 'reveal the breeds of your mutt' dog DNA tests.
  - crusso 13y ago
    Literally, my mom is the one who got me to send off my spit to 23andMe. She thinks it's fun and interesting but at no point has she indicated that she's thinking of it as a medical service - especially not one that replaces seeing a doctor.
- dragonwriter 13y ago
  > I think most people view their service as fun thing If they were marketing as an entertainment product, this wouldn't be an issue. They are marketing it as a diagnostic product (and apparently submitted applications for FDA clearance as such, but then just decided to ignore that process and continue marketing it for diagnosing risks.)
- tptacek 13y ago
  Someone ought to inform 23AM of that: Find out if your children are at risk for inherited conditions, so you can plan for the health of your family. Understand your genetic health risks. Change what you can, manage what you can't. Arm your doctor with information on how you might respond to certain medications. Document your family health history, track inherited conditions, and share the knowledge. Explore your genetic traits for everything from lactose intolerance to male pattern baldness. This is right there on their website.
  - randallsquared 13y ago
    What you quote explicitly mentions going to your doctor with results. Do they need to work "see your doctor" into every single sentence?
    - tptacek 13y ago
      You think diagnostic services sold to doctors aren't a concern for the FDA? Virtually every medical product or service the FDA regulates is marketed primarily to doctors. Anyways, my comment was a response to the commenter who claimed 23AM was marketed as "entertainment". Horseshit.
    - smackfu 13y ago
      No, they need to prove to the FDA that their tests do each of those things. If they say the test lets you find out "if your children are at risk for inherited conditions", should the FDA just trust them about that? I mean, that's a pretty serious thing to be testing for.
- DanBC 13y ago
  > I think most people view their service as fun thing Cool. 23andMe should sell it like that. It seems most of the FDA letter is about how the tests are being sold.
- k-mcgrady 13y ago
  >> "I think most people view their service as fun thing" The problem is that's not how they are marketing it as others have pointed out. They market it as a serious health evaluation tool you can use as a step in preventing future illness.
  - Glyptodon 13y ago
    Should personality and health quizzes in magazines also need FDA approval? Q: Have you eaten fast food more than 3x this week? A: If yes, you may be at risk for obesity (or just plain lazy)! See a medical professional for verification and treatment options! By the way, check out this insurance plan! And these nutritional supplements! I mean there's a whole industry of publications, websites, media, and more dedicated to getting people to self-diagnose and self-treat all kinds of conditions and doing it without FDA approval... http://www.diabetesforecast.org/ http://www.diabetesforecast.org/ http://www.weightwatchers.com/shop/mag/ http://www.weightwatchers.com/shop/mag/ http://www.healthylm.com/ http://www.healthylm.com/ http://www.womenshealthmag.com/life http://www.womenshealthmag.com/life http://www.fitnessmagazine.com/ http://www.fitnessmagazine.com/ http://www.foodandnutrition.org/ http://www.foodandnutrition.org/ http://paleomagonline.com/ http://paleomagonline.com/ ... etc. I don't even think I've gotten to most of the egregious ones because they use trickier to find names. But they're all basically promoting self diagnosis and self-treatment of conditions that may or may not exist or methods of managing or treating conditions that do in fact exist. It seems like a double standard to me.
    - HeyLaughingBoy 13y ago
      There is no double standard. The definition of a Medical Device is quite clear: http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm http://www.fda.gov/medicaldevices/deviceregulationandguidanc... Besides this not being part of the FDA's charter, what you're ignoring is that articles assist you (correctly or otherwise!) in self-diagnosis. An article does not in and of itself diagnose you with a disease or condition and thus can't by any stretch of the imagination be considered a Device.
- icedchai 13y ago
  Yes, that's what I view it as, as a subscriber to 23 and Me. Though, fortunately, I also haven't seen anything that as a real concern that I didn't already know about from family history.
ig1 13y ago
Couldn't the same argument be applied to WebMD's symptom checker ?
- metaphorm 13y ago
  no. the symptom checker is just a document. it is a not a device or an ingested substance.
  - Dylan16807 13y ago
    23AM's offering is in two parts. First, they do some genetic mapping. Second, they do an analysis on the markers found. The objections are based on the second part (and the marketing for it), which seems by itself to be very equivalent to WebMD. I don't think there's any suggestion that abstract-genetic-marker-finding is the problem here.
    - smackfu 13y ago
      Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results.
      - Dylan16807 13y ago
        There is a difference between mechanical analysis and medical analysis. Obviously they need to analyze the raw signals coming out of the machine to figure out what markers are present. But they could stop there, saying "with four nines certainty you have genes ABJ2, CBI8, LOC9, JOLO, ZZT". The FDA is objecting to doing a medical correlation/explanation beyond that point, doing the things WebMD does.
        smackfu 13y ago
        To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.
dragonwriter 13y ago
> Am I the only one this seems completely reasonable to? No, particularly from an "FDA" rather than "Congress" viewpoint. That is, independently of whether the law should have the FDA regulating devices used to diagnose disease, the facts seem to be: 1) The FDA does have that responsibility under the FD&C Act, 2) 23andMe began the process of getting FDA clearance for a device intended to diagnose a disease, and 3) 23andMe, when the FDA found the application wasn't sufficient and asked for more information to support that the device met the requirements for approval, failed to respond with more information and just accelerated public marketing of the device. Unless there is substantial dispute over these facts -- which I don't see any indication of -- there doesn't seem to be any basis for criticizing the FDA action.
- deleted 13y ago
  [deleted]
lnanek2 13y ago
Seems pretty stupid to me. I've enhanced DNA signals using the enzyme used for this in lab class plenty of times, and ran analysis on them. It's pretty trivial nowadays. 23andme does this and runs the result over a gene array and reads out the answers. There should be nothing illegal about this. If you want to slap a disclaimer that it isn't perfect on the mailing envelope, fine, but it's none of the government's business to say we can't have someone do it for us IMO. They should be hunting down fraud and not killing useful lab tests with pointless paperwork.
- carbocation 13y ago
  The FDA is not trying to prevent you from doing this with your own genes. They are trying to prevent unlawful marketing of a medical device. Despite the similarities that you point out, these are in fact quite different things.
- zekenie 13y ago
  Its a simple procedure but from an epidemiological prospective, different screening methods are ideal for different slices of the population. If something has a very high false positive rate, it's a terrible screening tool... I think a lot of the concern is that someone might receive bad news and change their anti-coagulant dose because of a false positive. Even if that only happens to 0.1% of people, it could kill people. The point is that doctors don't market these tests to the public like that.
  - hacker789 13y ago
    Not having a test done could kill people, too.
    - mbreese 13y ago
      And because of that, perhaps you should be getting that test (or not getting the test), with the help of a physician who is better equipped to help you interpret the results. Or at maybe for particular results the company should just refer you straight to a doctor for more information. These are the questions that I think the FDA will be interested in having the company addressing.
aabalkan 13y ago
1. They sign a terms of use agreement. 2. 23andMe asks for "are you sure, this can have impact on your health?" when you want to see your health risks. 3. 23AndMe interface has health risks with a "confidence level", for example, my Alzheimer's probability is 10% higher than avg risk and confidence level is 4/4. I find your argument invalid. If they get an approval from FDA, is it going to change their data processing logic or data set?
- stdbrouw 13y ago
  > If they get an approval from FDA, is it going to change their data processing logic or data set? It (or the marketing) would have to change if they don't get an approval. That's the whole point.
- dragonwriter 13y ago
  If they get an FDA approval, it would mean that there has been review that their outputs are actually appropriate. That's why the FDA is required by law to review items marketed for diagnosing disease.
- jrochkind1 13y ago
  > I find your argument invalid. If they get an approval from FDA, is it going to change their data processing logic or data set? I guess it would depend on if the FDA finds their data processing logic to result in valid and reliable medical determinations, right? They also might have to change their marketting materials to comply, something specifically mentioned in the FDA letters. Regulation to prevent misleading marketting of medical products is definitely a pretty core part of the FDA's remit.
stevenbedrick 13y ago
Nope, you're not the only one. I've been wondering for years how 23andMe has been getting away with what is clearly a flagrant violation of FDA marketing rules.
crusso 13y ago
23andMe offers a very low cost way to open the door to a whole new world of having people understand something about their genetic makeup and the possible impact upon their lives. The work that they're doing to show how genetic features correlate with the observed tastes, behaviors, and propensities of users of the site seems remarkably useful. The FDA is doing exactly what it always does, stifling innovation while justifying its existence using the voluminous laws created by politicians justifying their existences. If the FDA were useful, it would be helping 23andMe rather than trying to take them down.
- rayiner 13y ago
  > The work that they're doing to show how genetic features correlate with the observed tastes, behaviors, and propensities of users of the site seems remarkably useful. Oh man are you going to be upset when we regulate all that out of existence. Trying to correlate genetics to tastes, behaviors, and propensities, while scientifically interesting, is a total political non-starter. > The FDA is doing exactly what it always does, stifling innovation while justifying its existence using the voluminous laws created by politicians justifying their existences. This action is the FDA acting within the core of its jurisdiction, and within the core of a law that was passed with tremendous public support. This is not to say that agencies don't do what you're describing, but in this case, it's pretty much the FDA's job to control this sort of "innovation."
  - masklinn 13y ago
    > while scientifically interesting I'm not sure "interesting" is the word I'd have used. "Unlikely" is probably much, much closer to the truth. It's more or less astrology.
    - crusso 13y ago
      Correlating genetics to propensities is astrology? So, correlating the existence of certain genes to propensity of heart disease is mumbo jumbo? Not really sure why anyone would say such a thing. Maybe you didn't understand what the word "propensities" means?
VMG 13y ago
Isn't 23andMe very open and explicit about the accuracy of their claims?
- dragonwriter 13y ago
  They make explicit claims about the accuracy of their reports. Whether there is the appropriate support to make those claims about a product marketed to consumers as a diagnostic tool is the question here.
rayiner 13y ago
> Am I the only one this seems completely reasonable to? No. I'm not actually a big pro-regulation kind of guy. But there is a knee-jerk reaction favoring tech-ish companies getting regulatory compliance letters that I don't share. Most of the time, it just seems like the agency in question doing its statutorily-sanctioned job. It's not like sympathetic cases where a company falls into a Kafka-esque quagmire of obscure regulations that only tangentially apply to what they're doing. When I see cases like this, or AirBnB, or Uber, they fall directly within the scope of the relevant agency, and the action being taken is justified on the same basis that justifies the agency itself.
- FireBeyond 13y ago
  Right. There are some areas where more due diligence is required than to wave one's hands and chant "Disrupt!" And in this case, at least from their perspective, the FDA hasn't been unwilling to work with 23-and-me.
anigbrowl 13y ago
No. This letter is a model of clear communication and reasoned argument. I think 23andme is a great concept and admire what they're doing; I hope they get their ducks in a row so they can develop their offerings more effectively.
grandalf 13y ago
Of all the things that have a clear negative impact on health, 23andme's existence and business practices do not (in my opinion) merit a single hour of agency/burocratic time. FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game. Every single piece of information on 23andme is accompanied by confidence estimate, and most of it is very low confidence. Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality. As a happy 23andme customer I wish the FDA would stop harassing a company I enjoy doing business with so that it can get on with releasing new data and building new features rather than just hiring lawyers.
- dragonwriter 13y ago
  > FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game. No, FDA interest in 23andMe is driven by: 1) The fact that 23andMe's product is within the clear scope of what FDA is tasked to regulate under the FD&C Act, and 2) The fact that, having initiated the process of seeking regulatory clearance for their product as required, 23andMe abandoned that process and continued marketing the product. > Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality. Really? The lack of studies supplied by 23andMe establishing the validity of their process in delivering the outputs it gives is "addressed by the site as part of its core functionality"? How?
  - grandalf 13y ago
    I'd address your first point with a simple question: Suppose 23andme did no data analysis/interpretation and simply returned the raw data, would that increase or decrease the scope of appropriate FDA involvement? To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians.
    - dragonwriter 13y ago

wissler 13y ago

As if the FDA were qualified to make such determinations.

Glyptodon 13y ago

Probably. I think most people view their service as fun thing that comes back with results that, if revealing of a concern, would cause you to seek proper and more detailed testing from a real medical practitioner. It's not like a physician prescribes a 23 & me writeup.

rayiner 13y ago
> I think most people view their service as fun thing that comes back with results that, if revealing of a concern Take this thought, and replace "some people" with "my mom" and see if it still results in the same conclusion.
- Glyptodon 13y ago
  Yep. I'm pretty sure she'd view it along the same lines as one of those 'reveal the breeds of your mutt' dog DNA tests.
- crusso 13y ago
  Literally, my mom is the one who got me to send off my spit to 23andMe. She thinks it's fun and interesting but at no point has she indicated that she's thinking of it as a medical service - especially not one that replaces seeing a doctor.
dragonwriter 13y ago
> I think most people view their service as fun thing If they were marketing as an entertainment product, this wouldn't be an issue. They are marketing it as a diagnostic product (and apparently submitted applications for FDA clearance as such, but then just decided to ignore that process and continue marketing it for diagnosing risks.)
tptacek 13y ago
Someone ought to inform 23AM of that: Find out if your children are at risk for inherited conditions, so you can plan for the health of your family. Understand your genetic health risks. Change what you can, manage what you can't. Arm your doctor with information on how you might respond to certain medications. Document your family health history, track inherited conditions, and share the knowledge. Explore your genetic traits for everything from lactose intolerance to male pattern baldness. This is right there on their website.
- randallsquared 13y ago
  What you quote explicitly mentions going to your doctor with results. Do they need to work "see your doctor" into every single sentence?
  - tptacek 13y ago
    You think diagnostic services sold to doctors aren't a concern for the FDA? Virtually every medical product or service the FDA regulates is marketed primarily to doctors. Anyways, my comment was a response to the commenter who claimed 23AM was marketed as "entertainment". Horseshit.
  - smackfu 13y ago
    No, they need to prove to the FDA that their tests do each of those things. If they say the test lets you find out "if your children are at risk for inherited conditions", should the FDA just trust them about that? I mean, that's a pretty serious thing to be testing for.
DanBC 13y ago
> I think most people view their service as fun thing Cool. 23andMe should sell it like that. It seems most of the FDA letter is about how the tests are being sold.
k-mcgrady 13y ago
>> "I think most people view their service as fun thing" The problem is that's not how they are marketing it as others have pointed out. They market it as a serious health evaluation tool you can use as a step in preventing future illness.
- Glyptodon 13y ago
  Should personality and health quizzes in magazines also need FDA approval? Q: Have you eaten fast food more than 3x this week? A: If yes, you may be at risk for obesity (or just plain lazy)! See a medical professional for verification and treatment options! By the way, check out this insurance plan! And these nutritional supplements! I mean there's a whole industry of publications, websites, media, and more dedicated to getting people to self-diagnose and self-treat all kinds of conditions and doing it without FDA approval... http://www.diabetesforecast.org/ http://www.diabetesforecast.org/ http://www.weightwatchers.com/shop/mag/ http://www.weightwatchers.com/shop/mag/ http://www.healthylm.com/ http://www.healthylm.com/ http://www.womenshealthmag.com/life http://www.womenshealthmag.com/life http://www.fitnessmagazine.com/ http://www.fitnessmagazine.com/ http://www.foodandnutrition.org/ http://www.foodandnutrition.org/ http://paleomagonline.com/ http://paleomagonline.com/ ... etc. I don't even think I've gotten to most of the egregious ones because they use trickier to find names. But they're all basically promoting self diagnosis and self-treatment of conditions that may or may not exist or methods of managing or treating conditions that do in fact exist. It seems like a double standard to me.
  - HeyLaughingBoy 13y ago
    There is no double standard. The definition of a Medical Device is quite clear: http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm http://www.fda.gov/medicaldevices/deviceregulationandguidanc... Besides this not being part of the FDA's charter, what you're ignoring is that articles assist you (correctly or otherwise!) in self-diagnosis. An article does not in and of itself diagnose you with a disease or condition and thus can't by any stretch of the imagination be considered a Device.
icedchai 13y ago
Yes, that's what I view it as, as a subscriber to 23 and Me. Though, fortunately, I also haven't seen anything that as a real concern that I didn't already know about from family history.

ig1 13y ago

Couldn't the same argument be applied to WebMD's symptom checker ?

metaphorm 13y ago
no. the symptom checker is just a document. it is a not a device or an ingested substance.
- Dylan16807 13y ago
  23AM's offering is in two parts. First, they do some genetic mapping. Second, they do an analysis on the markers found. The objections are based on the second part (and the marketing for it), which seems by itself to be very equivalent to WebMD. I don't think there's any suggestion that abstract-genetic-marker-finding is the problem here.
  - smackfu 13y ago
    Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results.
    - Dylan16807 13y ago
      There is a difference between mechanical analysis and medical analysis. Obviously they need to analyze the raw signals coming out of the machine to figure out what markers are present. But they could stop there, saying "with four nines certainty you have genes ABJ2, CBI8, LOC9, JOLO, ZZT". The FDA is objecting to doing a medical correlation/explanation beyond that point, doing the things WebMD does.
      - smackfu 13y ago
        To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.

dragonwriter 13y ago

> Am I the only one this seems completely reasonable to? No, particularly from an "FDA" rather than "Congress" viewpoint. That is, independently of whether the law should have the FDA regulating devices used to diagnose disease, the facts seem to be: 1) The FDA does have that responsibility under the FD&C Act, 2) 23andMe began the process of getting FDA clearance for a device intended to diagnose a disease, and 3) 23andMe, when the FDA found the application wasn't sufficient and asked for more information to support that the device met the requirements for approval, failed to respond with more information and just accelerated public marketing of the device. Unless there is substantial dispute over these facts -- which I don't see any indication of -- there doesn't seem to be any basis for criticizing the FDA action.

deleted 13y ago
[deleted]

lnanek2 13y ago

Seems pretty stupid to me. I've enhanced DNA signals using the enzyme used for this in lab class plenty of times, and ran analysis on them. It's pretty trivial nowadays. 23andme does this and runs the result over a gene array and reads out the answers. There should be nothing illegal about this. If you want to slap a disclaimer that it isn't perfect on the mailing envelope, fine, but it's none of the government's business to say we can't have someone do it for us IMO. They should be hunting down fraud and not killing useful lab tests with pointless paperwork.

carbocation 13y ago
The FDA is not trying to prevent you from doing this with your own genes. They are trying to prevent unlawful marketing of a medical device. Despite the similarities that you point out, these are in fact quite different things.
zekenie 13y ago
Its a simple procedure but from an epidemiological prospective, different screening methods are ideal for different slices of the population. If something has a very high false positive rate, it's a terrible screening tool... I think a lot of the concern is that someone might receive bad news and change their anti-coagulant dose because of a false positive. Even if that only happens to 0.1% of people, it could kill people. The point is that doctors don't market these tests to the public like that.
- hacker789 13y ago
  Not having a test done could kill people, too.
  - mbreese 13y ago
    And because of that, perhaps you should be getting that test (or not getting the test), with the help of a physician who is better equipped to help you interpret the results. Or at maybe for particular results the company should just refer you straight to a doctor for more information. These are the questions that I think the FDA will be interested in having the company addressing.

aabalkan 13y ago

1. They sign a terms of use agreement. 2. 23andMe asks for "are you sure, this can have impact on your health?" when you want to see your health risks. 3. 23AndMe interface has health risks with a "confidence level", for example, my Alzheimer's probability is 10% higher than avg risk and confidence level is 4/4. I find your argument invalid. If they get an approval from FDA, is it going to change their data processing logic or data set?

stdbrouw 13y ago
> If they get an approval from FDA, is it going to change their data processing logic or data set? It (or the marketing) would have to change if they don't get an approval. That's the whole point.
dragonwriter 13y ago
If they get an FDA approval, it would mean that there has been review that their outputs are actually appropriate. That's why the FDA is required by law to review items marketed for diagnosing disease.
jrochkind1 13y ago
> I find your argument invalid. If they get an approval from FDA, is it going to change their data processing logic or data set? I guess it would depend on if the FDA finds their data processing logic to result in valid and reliable medical determinations, right? They also might have to change their marketting materials to comply, something specifically mentioned in the FDA letters. Regulation to prevent misleading marketting of medical products is definitely a pretty core part of the FDA's remit.

stevenbedrick 13y ago

Nope, you're not the only one. I've been wondering for years how 23andMe has been getting away with what is clearly a flagrant violation of FDA marketing rules.

crusso 13y ago

23andMe offers a very low cost way to open the door to a whole new world of having people understand something about their genetic makeup and the possible impact upon their lives. The work that they're doing to show how genetic features correlate with the observed tastes, behaviors, and propensities of users of the site seems remarkably useful. The FDA is doing exactly what it always does, stifling innovation while justifying its existence using the voluminous laws created by politicians justifying their existences. If the FDA were useful, it would be helping 23andMe rather than trying to take them down.

rayiner 13y ago
> The work that they're doing to show how genetic features correlate with the observed tastes, behaviors, and propensities of users of the site seems remarkably useful. Oh man are you going to be upset when we regulate all that out of existence. Trying to correlate genetics to tastes, behaviors, and propensities, while scientifically interesting, is a total political non-starter. > The FDA is doing exactly what it always does, stifling innovation while justifying its existence using the voluminous laws created by politicians justifying their existences. This action is the FDA acting within the core of its jurisdiction, and within the core of a law that was passed with tremendous public support. This is not to say that agencies don't do what you're describing, but in this case, it's pretty much the FDA's job to control this sort of "innovation."
- masklinn 13y ago
  > while scientifically interesting I'm not sure "interesting" is the word I'd have used. "Unlikely" is probably much, much closer to the truth. It's more or less astrology.
  - crusso 13y ago
    Correlating genetics to propensities is astrology? So, correlating the existence of certain genes to propensity of heart disease is mumbo jumbo? Not really sure why anyone would say such a thing. Maybe you didn't understand what the word "propensities" means?

VMG 13y ago

Isn't 23andMe very open and explicit about the accuracy of their claims?

dragonwriter 13y ago
They make explicit claims about the accuracy of their reports. Whether there is the appropriate support to make those claims about a product marketed to consumers as a diagnostic tool is the question here.

rayiner 13y ago

> Am I the only one this seems completely reasonable to? No. I'm not actually a big pro-regulation kind of guy. But there is a knee-jerk reaction favoring tech-ish companies getting regulatory compliance letters that I don't share. Most of the time, it just seems like the agency in question doing its statutorily-sanctioned job. It's not like sympathetic cases where a company falls into a Kafka-esque quagmire of obscure regulations that only tangentially apply to what they're doing. When I see cases like this, or AirBnB, or Uber, they fall directly within the scope of the relevant agency, and the action being taken is justified on the same basis that justifies the agency itself.

FireBeyond 13y ago
Right. There are some areas where more due diligence is required than to wave one's hands and chant "Disrupt!" And in this case, at least from their perspective, the FDA hasn't been unwilling to work with 23-and-me.

anigbrowl 13y ago

No. This letter is a model of clear communication and reasoned argument. I think 23andme is a great concept and admire what they're doing; I hope they get their ducks in a row so they can develop their offerings more effectively.

grandalf 13y ago

Of all the things that have a clear negative impact on health, 23andme's existence and business practices do not (in my opinion) merit a single hour of agency/burocratic time. FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game. Every single piece of information on 23andme is accompanied by confidence estimate, and most of it is very low confidence. Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality. As a happy 23andme customer I wish the FDA would stop harassing a company I enjoy doing business with so that it can get on with releasing new data and building new features rather than just hiring lawyers.

dragonwriter 13y ago
> FDA interest in 23andme is driven solely by rent-seeking incumbents trying to keep 23andme out of the game. No, FDA interest in 23andMe is driven by: 1) The fact that 23andMe's product is within the clear scope of what FDA is tasked to regulate under the FD&C Act, and 2) The fact that, having initiated the process of seeking regulatory clearance for their product as required, 23andMe abandoned that process and continued marketing the product. > Every single concern mentioned in that letter is clearly and obviously addressed by the site as part of its core functionality. Really? The lack of studies supplied by 23andMe establishing the validity of their process in delivering the outputs it gives is "addressed by the site as part of its core functionality"? How?
- grandalf 13y ago
  I'd address your first point with a simple question: Suppose 23andme did no data analysis/interpretation and simply returned the raw data, would that increase or decrease the scope of appropriate FDA involvement? To your second point, the site has a few "locked" areas that are described as containing potentially upsetting or confusing information, and the user is advised to consult his/her physician before looking at the results. There is also downloadable information available to physicians.
  - dragonwriter 13y ago