What Really Drove 23andMe And The FDA Apart(fastcompany.com)
fastcompany.com
What Really Drove 23andMe And The FDA Apart
http://www.fastcompany.com/3022891/innovation-agents/exclusive-what-really-drove-23andme-and-the-fda-apart
13 comments
> You don't go out, do what you want, and then be surprised when you get shut-down.
That's how it _ought_ to be in a free republic.
That's how it _ought_ to be in a free republic.
Not all "freedoms" are alike. As the saying goes, your freedom to swing your fist ends at the tip of my nose. And your freedom to make unproven medical claims for a product you're selling ends at my freedom to buy medical products with confidence that they are safe and will do what they claim to do.
Without getting into a semantics argument about whether your example is even really a freedom or not (just like I could say "clearly my freedom to read minds isn't respected because it doesn't even work!!!!"), I think there is a huge, ridiculous, and obvious difference between physically assaulting someone and giving you data about your genome.
I am an adult, I paid for 23andme with my money, and I understand the limitations of their data. If I'm worried about something in particular I'll go to the doctor, since they spell it out all over the place that none of this stuff is final (not to mention the fact that the only thing they even ever tell you is like "1% elevated risk"). I don't need mama government stepping in and making sure I'm not being mislead (which is hilarious because it is on the other hand 100% legal to be a fortune teller and tell someone not to worry since that pesky cancer won't be terminal according to these tarot cards).
I am an adult, I paid for 23andme with my money, and I understand the limitations of their data. If I'm worried about something in particular I'll go to the doctor, since they spell it out all over the place that none of this stuff is final (not to mention the fact that the only thing they even ever tell you is like "1% elevated risk"). I don't need mama government stepping in and making sure I'm not being mislead (which is hilarious because it is on the other hand 100% legal to be a fortune teller and tell someone not to worry since that pesky cancer won't be terminal according to these tarot cards).
The FDA is reacting to the marketing/advertising, not the product itself. If the fortune teller was promoting himself as "Bob the Medical Psychic" who can predict whether your cancer will be terminal, then that's a different story.
You're not allowed to make medical claims in advertisements that you can't back up. Cheerios famously got into trouble for claiming it's heart-healthy or some such.
You're not allowed to make medical claims in advertisements that you can't back up. Cheerios famously got into trouble for claiming it's heart-healthy or some such.
Yeah, but you have to think of the precedent: if 23andme doesn't have to provide proof that their results are accurate, there's nothing stopping me from starting a company that reads the lines on your palm and tells you if you will develop cancer. Regardless of the number of disclaimers they attach, people will use it to make medical decisions, and 23andme was aggressively advertising capabilities they had not proven. There is (and should be) a higher standard of proof for medical services/devices/etc.
The FDA was started because companies were making medicines that either didn't work or weren't safe and people were relying on them. Consumers lost faith in the health care industry, so we have a much higher standard of care. I understand that it's expensive, difficult and time consuming to fulfill this higher burden of proof, but the alternative applied across the entire market really just shifts those costs to the consumer while degrading confidence in the market for medical services overall.
The FDA was started because companies were making medicines that either didn't work or weren't safe and people were relying on them. Consumers lost faith in the health care industry, so we have a much higher standard of care. I understand that it's expensive, difficult and time consuming to fulfill this higher burden of proof, but the alternative applied across the entire market really just shifts those costs to the consumer while degrading confidence in the market for medical services overall.
> Yeah, but you have to think of the precedent: if 23andme doesn't have to provide proof that their results are accurate, there's nothing stopping me from starting a company that reads the lines on your palm and tells you if you will develop cancer
Hate to break it to you, but this is already the case, and it had nothing to do with the "precedent" of 23andme. Go walk into a church of scientology or go read "The Secret" and tell me that's not what they're offering. Sure, they don't use the word "medical", but it doesn't matter. You are suffering from an educational bias, your worldview is completely divorced from that of the people you are trying to "protect". Most people don't understand that the term medical is no a mere colloquialism, nor do they understand that the lack of that term is a negative implication on the substance at hand. I speak from experience, my aunt died because she went to see quacks instead of a real doctor, despite all the information in the world available to her. Its perfectly legal to tell someone that doctors are full of shit and crystals are the real way to cure something. And you know what? At some point you need to just be OK with that. If not its just white man's burden all over again rebranded as "rich man's burden".
> The FDA was started because companies were making medicines that either didn't work or weren't safe and people were relying on them.
Hilarious. You want further proof of what I'm talking about? Go to the supplements isle at a grocery store. All that stuff is bullshit and often even specifically says "not approved by the FDA". Guess what? Its still a billion dollar business, and there are people who swear by that stuff and don't trust doctors. No one notices, cares, or understands. Again, your problem is that you are attacking this from a rational position and think that that is how other people operate as well, its not. You are kidding yourself if you think the FDA has succeeded in this goal.
> I understand that it's expensive, difficult and time consuming to fulfill this higher burden of proof
Ah and now we reach the best part about the FDA: that it effectively makes even educated people worse at making decisions. Despite the fact that the FDA has repeatedly been shown to be corrupt or in bed with certain companies, "approved by the FDA" is still a considered a trusted metric not requiring much further thought. Its not. The FDA has no competition and, like any government agency, incredibly rarely suffers consequences for being corrupt or making mistakes. Most people don't know "the burden of proof" required (and if you read about how bad doctors are at understanding statistics you wouldn't trust that burden of proof anyways).
Hate to break it to you, but this is already the case, and it had nothing to do with the "precedent" of 23andme. Go walk into a church of scientology or go read "The Secret" and tell me that's not what they're offering. Sure, they don't use the word "medical", but it doesn't matter. You are suffering from an educational bias, your worldview is completely divorced from that of the people you are trying to "protect". Most people don't understand that the term medical is no a mere colloquialism, nor do they understand that the lack of that term is a negative implication on the substance at hand. I speak from experience, my aunt died because she went to see quacks instead of a real doctor, despite all the information in the world available to her. Its perfectly legal to tell someone that doctors are full of shit and crystals are the real way to cure something. And you know what? At some point you need to just be OK with that. If not its just white man's burden all over again rebranded as "rich man's burden".
> The FDA was started because companies were making medicines that either didn't work or weren't safe and people were relying on them.
Hilarious. You want further proof of what I'm talking about? Go to the supplements isle at a grocery store. All that stuff is bullshit and often even specifically says "not approved by the FDA". Guess what? Its still a billion dollar business, and there are people who swear by that stuff and don't trust doctors. No one notices, cares, or understands. Again, your problem is that you are attacking this from a rational position and think that that is how other people operate as well, its not. You are kidding yourself if you think the FDA has succeeded in this goal.
> I understand that it's expensive, difficult and time consuming to fulfill this higher burden of proof
Ah and now we reach the best part about the FDA: that it effectively makes even educated people worse at making decisions. Despite the fact that the FDA has repeatedly been shown to be corrupt or in bed with certain companies, "approved by the FDA" is still a considered a trusted metric not requiring much further thought. Its not. The FDA has no competition and, like any government agency, incredibly rarely suffers consequences for being corrupt or making mistakes. Most people don't know "the burden of proof" required (and if you read about how bad doctors are at understanding statistics you wouldn't trust that burden of proof anyways).
The FDA did propose regulations to restrict the advertising of "vitamins" and other supplements. In response, the industry convinced Congress to pass a law preventing the FDA from issuing such regulation.
The FDA would love to regulate the supplement market. They simply can't.
Also, "approved by the FDA" isn't a trust metric that anyone relies on. It's a very basic, fundamental requirement for all medical drugs, devices, and procedures.
The FDA would love to regulate the supplement market. They simply can't.
Also, "approved by the FDA" isn't a trust metric that anyone relies on. It's a very basic, fundamental requirement for all medical drugs, devices, and procedures.
>"approved by the FDA" is still a considered a trusted metric not requiring much further thought
This is a false statement.
See the Dietary Supplement Health And Education Act of 1994 which is a failure of government to protect citizens best interests in favor of the industry.
http://www.quackwatch.com/02ConsumerProtection/dshea.html
This is a false statement.
See the Dietary Supplement Health And Education Act of 1994 which is a failure of government to protect citizens best interests in favor of the industry.
http://www.quackwatch.com/02ConsumerProtection/dshea.html
However, as always there are externalities. So far, BRCA gene screening was only done for women with a family history of breast cancer. One fears that now everyone with a 23andme positive test result will consult their physician, and if their test yields too many false positives this will be a plain waste of money. I don't want to pay for someone else's unvalidated test.
The strategy of 23andme is to collect genomic data and correlate it with phenotypic data to get a handle on variations. They will sell the data, either to pharmcos or themselves; if they do it themselves they will need to do trialing to ensure that their test does measure what they say it measures.
This stunt serves to hollow out the FDA and get an end-run around clinical trials.
The strategy of 23andme is to collect genomic data and correlate it with phenotypic data to get a handle on variations. They will sell the data, either to pharmcos or themselves; if they do it themselves they will need to do trialing to ensure that their test does measure what they say it measures.
This stunt serves to hollow out the FDA and get an end-run around clinical trials.
How would you be paying for someone else's unvalidated test? It's not as though you can go to the emergency room and say "23andme said I have elevated risk for XYZ so I need a genetic test real bad!" and get one. So what's the mechanism for you to be forced to pay for someone else's tests?
Sure. While we're at it, let's get rid of meat inspections too.
Fun fact: none of the meat purchased by mcdonalds for their burgers is FDA approved. :)
It's not TSA approved either. Or NSA. Or EPA. None of these agencies, FDA included, have anything to do with meat inspections.
Meat inspections are under the purview of the USDA thanks to the Federal Meat Inspection Act.
Meat inspections are under the purview of the USDA thanks to the Federal Meat Inspection Act.
It is USDA-inspected, however.
Many people don't know the difference. That's what makes it the shocking truth about McDonald's you need to learn!
Meat is regarded as an agricultural product until it is actually included in a food product or is packaged for sale as a food product. Agricultural products are regulated by the USDA, foodstuffs are regulated by the FDA.
USDA inspections are primarily visual. However, fast food chains use bacterial counts, which are believed to be more effective, to pass/fail batches of meat they receive.
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Medical false-claims have a higher standard of due care for good reasons. Not only are there issues with potential non-reversal, but the search and diligence costs are un-economic for individuals to verify acting in isolation. That's doesn't justify anyone's bad behaviour, but dismissing the problem out of hand is not really helpful.
>The FDA has been asking 23andMe for specific studies on the reliability and efficacy
> 23andMe is incredibly naive.
Also, what is their lawyer doing, allowing them to make statements like "23andMe contends that the reliability of its test kits and data adheres to the highest standards, that its process matches that of a DNA test one would get through a physician" in the middle of this sort of agency action? Maybe the author's paraphrase is wildly wrong, but in this sort of situation, you don't really want to go on the public record doubling down on your position that your product is as good as what you'd get through a doctor, while arguing that it shouldn't be regulated as a medical test.
Also, what is their lawyer doing, allowing them to make statements like "23andMe contends that the reliability of its test kits and data adheres to the highest standards, that its process matches that of a DNA test one would get through a physician" in the middle of this sort of agency action? Maybe the author's paraphrase is wildly wrong, but in this sort of situation, you don't really want to go on the public record doubling down on your position that your product is as good as what you'd get through a doctor, while arguing that it shouldn't be regulated as a medical test.
23andMe is incredibly naive.
Naive? To cynical me this dustup is a PR stunt, they want exposure and to put public pressure on the FDA to be allowed to continue just as they did in the past.
Naive? To cynical me this dustup is a PR stunt, they want exposure and to put public pressure on the FDA to be allowed to continue just as they did in the past.
This is a fairly even and well thought out piece but the author does seem to be a fan of 23andme: the author suggests that the FDA should have contacted 23andme semi-formally before because 23andme has a high turnover and their senior management is having a tough personal time. This is a bit funny. The author is basically suggesting that the management of 23andme is incompetent and the FDA needs to make allowances for this incompetence.
Otherwise the article nicely lays out the tensions between consumer advocacy, scientific rigor and sales.
Otherwise the article nicely lays out the tensions between consumer advocacy, scientific rigor and sales.
It seems as though the author may be making up for some embarrassment on the part of the editors for putting 23 on the cover of fast company recently.
Fastcompany and its editors are not at fault here. It's up to 23andMe to be prepared.
It's clear that 23 thinks that the FDA is incapable of enforcing their mandate and is daring them to do something about it in the media. This is just more BS spin to try to justify their bold and reckless PR maneuvering, under the guise of super-important and helpful medical technology being held back by big bad careless government regulation. I hope 23 continues to pretend like it does nothing wrong in the boardroom, while playing the media through their Google trumpet.
This really got me:
> or a recognition from the FDA that, given turnover at 23andMe (and Wojcicki’s distraction due to her public separation from husband Sergey Brin), the task of initiating outreach fell to them.
That's laughably ludicrous.
> or a recognition from the FDA that, given turnover at 23andMe (and Wojcicki’s distraction due to her public separation from husband Sergey Brin), the task of initiating outreach fell to them.
That's laughably ludicrous.
You've never had to deal with a three letter agency as a corporation, have you? It's very difficult to ascertain when they want you to take a proactive step to "initiate outreach" and when you're supposed to contact them. And when there's a delay, who knows.
In registering my nonprofit with the IRS, I sent in my 1024s, and promptly got a letter back, "we will get back to you in 90 days." It's been 180-ish days. Static. What now? Who contacts whom?
In registering my nonprofit with the IRS, I sent in my 1024s, and promptly got a letter back, "we will get back to you in 90 days." It's been 180-ish days. Static. What now? Who contacts whom?
I must confess that your first sentence aggravates me. It comes across as an accusation that I am not qualified to have made the comment that I did. With that in mind, yes, I have.
But that's irrelevant.
Anyway, you missed my point. My comment did not imply that it was obviously not the FDA's responsibility to make contact. (Nevermind the fact that at the end of the day, it was in fact the FDA that did reach out to 23andMe.) I did imply, however, that turnover at 23andMe and Anne's marital issues were ludicrous reasons for it to have been the responsibility of the FDA.
But that's irrelevant.
Anyway, you missed my point. My comment did not imply that it was obviously not the FDA's responsibility to make contact. (Nevermind the fact that at the end of the day, it was in fact the FDA that did reach out to 23andMe.) I did imply, however, that turnover at 23andMe and Anne's marital issues were ludicrous reasons for it to have been the responsibility of the FDA.
That's why, when you are about to step into the FDA's purview, you hire people who have experience running a quality system which adheres to FDA guidelines or, at a minimum, a consultant with similar experience. Ignorance is not a defense, and in practice, it doesn't really matter; they can shut you down, you can't do shit about it.
Who contacts who? the party that has less power contacts the party that has more power.
that is the way of the world, always has been, always will be
that is the way of the world, always has been, always will be
To me (software engineer working genetic research) the biggest issue is that 23andme is being represented as a cutting edge genomic tech while offering a test on an simplistic, outdated tech (a genotype array).
Even intelligent, technically minded people get taken in thinking they have "had there genome sequenced" when they are getting tested for a small number of single nucleotide polymorphisms (SNPs).
The scientific reality is that, while there are some well established correlations between SNPs and disease, the explanatory power of such simple tests and validity of studies based on them is in question [1].
Getting a genotype for 99 bucks is a cool service but I worry that the marketing that goes along with it is doing more to misinform than educate. I wish they had pushed more towards offering actual sequencing to consumers as prices fall.
[1] http://en.wikipedia.org/wiki/Genome-wide_association_study#L...
Even intelligent, technically minded people get taken in thinking they have "had there genome sequenced" when they are getting tested for a small number of single nucleotide polymorphisms (SNPs).
The scientific reality is that, while there are some well established correlations between SNPs and disease, the explanatory power of such simple tests and validity of studies based on them is in question [1].
Getting a genotype for 99 bucks is a cool service but I worry that the marketing that goes along with it is doing more to misinform than educate. I wish they had pushed more towards offering actual sequencing to consumers as prices fall.
[1] http://en.wikipedia.org/wiki/Genome-wide_association_study#L...
What about the ancestry information? Is that more useful?
Nope. Me and my Dad did tests at 23andme and a British university lab and according to the 23andme test i'm not a family member of well.. myself (nor my dad). If a test is not good enough to predict family members or even the same person i would not hold any of their other 'conclusions' in high regard either.
I wonder if there was a bit of 'tech' clash with old school 'medicine' clash. Basically tech folks take the position of move forward and fix things that break, rather than wait until you are 99.999% nothing will break and then move forward. If that were the case, I could imagine a product manager getting incentivised to get the kits out the door and testing ramped up in spite of FDA reservations because 'hey it isn't like its something people take or anything.'
It would make an interesting short story (fiction of course) of a Doctor who invents a cure for cancer and starts giving it to people in his family who have cancer, and curing them but gets thrown into jail by a regulator, whose spouse dies of cancer during the clinical trials. The character conflict of someone who is doing the right thing at great personal cost, compared to someone who did the wrong thing for personal benefit, vs the overall 'right vs wrong' of the entire system. If someone picks up this story line add a thank you to me in the forward :-)
It would make an interesting short story (fiction of course) of a Doctor who invents a cure for cancer and starts giving it to people in his family who have cancer, and curing them but gets thrown into jail by a regulator, whose spouse dies of cancer during the clinical trials. The character conflict of someone who is doing the right thing at great personal cost, compared to someone who did the wrong thing for personal benefit, vs the overall 'right vs wrong' of the entire system. If someone picks up this story line add a thank you to me in the forward :-)
> I wonder if there was a bit of 'tech' clash with old school 'medicine' clash. Basically tech folks take the position of move forward and fix things that break, rather than wait until you are 99.999% nothing will break and then move forward. If that were the case, I could imagine a product manager getting incentivised to get the kits out the door and testing ramped up in spite of FDA reservations because 'hey it isn't like its something people take or anything.'
Replace "product manager" with "marketing exec", and I think you have it right here. The FDA's problem with 23AndMe isn't with the tech, it's with the marketing. The FDA has asked for studies proving that 23AndMe's marketing is correct, and so far, 23AndMe has not produced the results of the studies.
This isn't anything new, too. Here's what the FDA said to General Mills about their Cherrios advertising in 2009: http://en.wikipedia.org/wiki/Cheerios#2009_Drug_Claim
Replace "product manager" with "marketing exec", and I think you have it right here. The FDA's problem with 23AndMe isn't with the tech, it's with the marketing. The FDA has asked for studies proving that 23AndMe's marketing is correct, and so far, 23AndMe has not produced the results of the studies.
This isn't anything new, too. Here's what the FDA said to General Mills about their Cherrios advertising in 2009: http://en.wikipedia.org/wiki/Cheerios#2009_Drug_Claim
There is a somewhat proud history of Doctors self experimenting:
http://en.wikipedia.org/wiki/Self-experimentation_in_medicin...
http://en.wikipedia.org/wiki/Self-experimentation_in_medicin...
I doubt the FDA would find the time to care if the people at 23andMe were just sitting around diagnosing themselves like a bunch of hypochondriacs. Their interaction with the public is what has gotten the FDA's attention.
There is a rather shameful history of doctors experimenting on others in an improper fashion.
There is a rather shameful history of doctors experimenting on others in an improper fashion.
It looks like the article may have been taken down. Here's Google's cached copy: http://webcache.googleusercontent.com/search?q=cache:http://...
? This link now seems to redirect to an unrelated article[1]... very confusing...
[1] http://www.fastcodesign.com/node/1840715
[1] http://www.fastcodesign.com/node/1840715
Every modern car as an 'ODB2' connector under the dashboard, which allows anyone with 99 dollars to monitor the statistics of their vehicles - engine temperature, fuel efficiency, air pressure, et al.
Thought experiment: If everyone all of a sudden had all this information on their dash tonight, how many would change their natural driving habits because of the visible information, even if no metric was any different than the every day before it?
I won't speculate. It's just a metaphor.
Thought experiment: If everyone all of a sudden had all this information on their dash tonight, how many would change their natural driving habits because of the visible information, even if no metric was any different than the every day before it?
I won't speculate. It's just a metaphor.
No it isn't a metaphor. Not a good one anyway.
Medical screening tests are a costs benefits analysis. Science does this.
There is a cost for everything. If you have a disease that isn't causing any symptoms, do you treat it, even though it will probably never cause symptoms? There is a risk in all treatments, some more than others. There is a study that most prostate cancers don't show symptoms, ever and our super sensitive cancer diagnostics tests are causing more harm than good. More diagnostics does not mean more good. That's why we no longer do the Prostate-Specific Antigen (PSA) Test. It finds too many cancers that aren't going to cause harm and then people get unneeded treatment that causes side effects. (Source in: http://en.wikipedia.org/wiki/Prostate-specific_antigen)
For example, it used to be recommended that all women perform a breast self exam every month, then data showed us this didn't prevent cancer and actually caused harm because it lead to needless surgeries and biopsies. (Sources here: http://en.wikipedia.org/wiki/Breast_self_exam)
We just don't throw more diagnosis and screening at patients and assume that is a good thing.
Medical screening tests are a costs benefits analysis. Science does this.
There is a cost for everything. If you have a disease that isn't causing any symptoms, do you treat it, even though it will probably never cause symptoms? There is a risk in all treatments, some more than others. There is a study that most prostate cancers don't show symptoms, ever and our super sensitive cancer diagnostics tests are causing more harm than good. More diagnostics does not mean more good. That's why we no longer do the Prostate-Specific Antigen (PSA) Test. It finds too many cancers that aren't going to cause harm and then people get unneeded treatment that causes side effects. (Source in: http://en.wikipedia.org/wiki/Prostate-specific_antigen)
For example, it used to be recommended that all women perform a breast self exam every month, then data showed us this didn't prevent cancer and actually caused harm because it lead to needless surgeries and biopsies. (Sources here: http://en.wikipedia.org/wiki/Breast_self_exam)
We just don't throw more diagnosis and screening at patients and assume that is a good thing.
Changing your driving habits from "slam the accelerator" to "accelerate slowly and evenly" or "brake hard to stop at the last moment for that stop sign" to "come to gradual stop" is hardly as reckless as "Stop taking as much Warfarin as you are because our tests (with no proven reliability) says you could take a lower dose".
Almost all the metrics you'd get out of of an ODB port would tell you to be gentler in your driving. Very few people feel comfortable in messing about with the guts of their car. Whereas many patients are more than happy to disobey their doctor's orders on a whim
Almost all the metrics you'd get out of of an ODB port would tell you to be gentler in your driving. Very few people feel comfortable in messing about with the guts of their car. Whereas many patients are more than happy to disobey their doctor's orders on a whim
This is another example of why the FDA should be privatized and operate more like Underwriters Labs. If a company chooses not to seek FDA certification and still has customers willing to pay for its products, the bureaucrats should butt out.
If 23andMe is making demonstrably fraudulent claims, that's an issue for the courts. Otherwise, the government shouldn't be using force to interfere with voluntary transactions that harm no one else.
If 23andMe is making demonstrably fraudulent claims, that's an issue for the courts. Otherwise, the government shouldn't be using force to interfere with voluntary transactions that harm no one else.
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Article has apparently been taken down; the link redirects to a fastcodedesign.com article on Bitcoin. Does anyone have a copy of the original article on 23andMe?
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>The FDA has been asking 23andMe for specific studies on the reliability and efficacy of its DNA test results as well as specific clinical analysis regarding health claims (for example, the risk of developing a condition that is associated with a genetic marker).
Makes sense. You're making certain medical claims, you darn better have something to back it up. What's their answer? Well:
>23andMe says it is working on satisfying those mandated requirements and admits it wishes its efforts were farther along.
Well, then you can't make those claims!!! What the heck did you expect the FDA to do!? Give you a break? Just this one time?!
> At the same time, 23andMe contends that the reliability of its test kits and data adheres to the highest standards, that its process matches that of a DNA test one would get through a physician.
PROVE IT! The reason why they haven't, I'm sure, is because it's expensive and time consuming. And possibly because the regulations around commercial DNA testing is out of date, maybe, but it is what it is.
>Last spring 23andMe began to ramp up the marketing efforts behind its DNA kits. This included TV and video ads and a direct-marketing campaign.
Of course that would be a problem. How you market your medical product factors greatly in whether or not you're going to be audited! Is this surprising to anyone at 23andMe !?!?
>Given the long history of dialogue with the FDA, you might imagine that 23andMe would have sought feedback about these initiatives--to see if any concerns surfaced or tweaks were requested
The FDA doesn't works like that. You're not going to get an a priori go ahead from them. The way it works is YOU have all YOUR homework done and ready, then go and market, and then if you get audited (and the FDA reserves the right to audit you anytime) the onus is on you to prove that your claims are sound and backed-up by proper evidence, that your quality system is in place and that your product is correctly classified and registered. If you don't have that, you get shut-down, and possibly more.
>The FDA, in turn, took no steps in the wake of this marketing wave to reach out to 23andMe and suggest caution or areas of concern.
The FDA is not your personal auditor or adviser. They don't work on your schedule. They aren't there to hand-hold 23andMe while they take their product to market.
Sometimes when you release a product in a new category, it may take the FDA a long time to come up with the right procedures and to amend the proper regulations, but them's apples. You don't go out, do what you want, and then be surprised when you get shut-down.