The FDA is now saying that Pathway (the manufacturer) bears the burden of proof to show that the test kit doesn't require FDA approval.
It's a frakking cheek swab. In what asylum do we need the government regulating things like this? It isn't a food. It isn't a drug.
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As an aside, Walgreens has announced that they will *not* be carrying these tests after all because of the brouhaha over the prior decision to sell them.
And I agree, it would seem that the FDA is the wrong agency to have their nose in this one. I have no idea who should be monitoring this sort of product. Personally, I'm not so sure it should exist at all.
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I don't know if the FDA is the right agency to be regulating this either. I do know they regulate medical devices such as the machine to check insulin levels. I can see their point though that this is going to provide medical information that without medical supervision could cause problems. Not all people are at all educated on how to evaluate risks. I would not want people using as reason to skip a mammogram. Or believing it predestined them to some cancer and thus not doing anything else to minimize their risks.
This sort of test is something that I would see doing much more good if it was accompanied by a meeting with a health professional.
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"Not so sure it should exist at all"? "More good if it was accompanied by a meeting with a health professional"? Whatever happened to letting people make their own choices?
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The only thing I was wondering was whether or not these tests are particularly accurate. I suppose it wouldn't be so bad for someone to look into that?
I don't know...it does seem odd that the FDA wants to regulate a cotton swab.
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*shrug* The article notes that your FDA regulates medical devices, like so
quote:Why does FDA approve medical devices before they can be sold? Before granting approval to manufacturers to sell their new devices, FDA science experts review the manufacturer’s data from investigational studies to see if: the product does what it claims to do effectively, and does not present any unreasonable risks to the patient.
posted
I'm generally in favor of FDA supervision, but in this case I don't think they have a leg to stand on. This is not a medical device: it's a test. For once, Jebus may have a point.
Now, I think the company providing them is asking for huge lawsuits when people use the results of these tests to do or avoid doing all sorts of things. But that's another question altogether.
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To answer jebus's question, the FDA regulates home use pregnancy tests as medical devices. In the "In Vitro Diagnostics" category.
I'm thinking that if pee-on-a-stick devices are subject to FDA approval, genetic material collection devices probably should be too. This is being marketed as a way to provide medical insight, after all.
(Other regulated medical devices include tongue depressors.)
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Pretty sure I've seen cheapie pregnancy tests for sale that had no indication of FDA anything, but maybe they were.
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I think that the idea that pregnancy tests and tongue depressors should be regulated like this is more the problem than evidence that this should also be regulated.
Fraud should still be prosecuted, of course (very important for pregnancy tests), but before-the-fact regulation? That's just bureaucracy gone amuck.
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Why would it be ok for a government agency to regulate an apple but not a dna test? An apple seems much more basic and easy to understand but yet we certainly let the FDA make rulings about food all the time.
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quote:If I were to create a pill, fill it with sugar, and sell it under the claim it will cure Cancer: the FDA would strike me down.
If I were to create a wrist-band, made of aluminum, and claim it will cure Cancer: the FDA shouldn't be able to do anything about it?
See: fraud. Completely prosecutable. I'm fine with the FDA being around and empowered to investigate medical fraud in such cases. I see no reason they should intervene prior to availability. Treating people like children is insulting, unnecessary, and counterproductive.
kmbboots: if you're asking me, again, fraud statutes are fine (I have no idea if they're currently regulated). Thermometers to be used by doctors or other medical professionals I would be fine with being regulated prior to availability.
edit: I also find the case slightly better for any claims to 'cure' things. Tongue depressors, thermometers, pregnancy tests, and DNA tests, none of them assert they cure anything. They are purely diagnostic.
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quote:Originally posted by fugu13: Fraud should still be prosecuted, of course (very important for pregnancy tests), but before-the-fact regulation? That's just bureaucracy gone amuck.
My concern would be something less than outright fraud but more deceptiveness. If for example pregnancy tests weren't required to print anything about how far in advance of a period they are effective or about what percentage of the time their test is accurate, how do you prosecute the fraud? For example, their test is only 50% accurate as compared to the 95% accurate that I would expect, how do I differentiate with 95% accurate being acceptable and 50% being fraud? The information on the box is necessary to proving the fraud.
This seems even more so the case with DNA tests. How accurate do they have to be? What precautions do they need to take? Without regulations in place there is absolutely nothing to prosecute. Unless the box gives specific information about accuracy, how do you prove anything illegal took place?
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I was asking generally. A diagnostic tool that doesn't work as it is supposed to work can have serious medical consequences. Surely it is better to test them beforehand than to sue or prosecute them for fraud after, for example, a child has died because the thermometer didn't work as it should have.
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fugu, you're right - existing regulation isn't a reason why this new device "should" be regulated. I'm not sure that the burden of having to get approval is worse than the harm that could be done (and then have to be prosecuted) after the fact (what kmbboots said), though. I don't know much about the regulatory overhead though.
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However, it does seem to indicate that the FDA is within their existing mandate to regulate such device, shifting the conversation away from "Why is FDA going to regulate this new product?" toward a conversation about "Why has the FDA been regulating this category of products and has it been working (or not) for the US?"
Related questions might be "What other countries regulate these products (and who doesn't) and how is it working out for them?"
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quote:If for example pregnancy tests weren't required to print anything about how far in advance of a period they are effective or about what percentage of the time their test is accurate, how do you prosecute the fraud?
Reporting requirements that are developed in response to legitimate consumer needs as such products become available seem entirely reasonable. False reporting would, of course, still be fraud. I don't see any need to attempt to divine what such required reporting would look like before the first such products go on the shelf.
As for DNA test accuracy, if they say they test your DNA for the presence of certain things, but someone shows (quite possibly through a counterfactual -- submitting a thoroughly pre-tested sample) they don't actually test your DNA for the presence of those things, that would be fraud.
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quote:Unless the box gives specific information about accuracy, how do you prove anything illegal took place?
There's a difference in how people see the role of the government here that I think is important to make explicit.
The nanny state assumption is that the government has a responsibility to prevent or at least strongly influence its citizens from making bad decisions.
The less intrusive government assumption is that the government should prevent outright fraud (and in most cases that they need to regulate harmful substances), but if people want to purchase something that makes no explicit claims to being at all accurate but doesn't represent any immediate threat, it is not the government's job to stop them.
I subscribe more to the second point of view and my response to that question is "Why would you buy a pregnancy test that doesn't make explicit claims about its accuracy?"
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quote:Personally, I'm not so sure it should exist at all.
I'm all for it being required for a product like this to be as reliable as possible, but why shouldn't it exist at all once it is reliable?
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quote:Originally posted by Rakeesh: I'm all for it being required for a product like this to be as reliable as possible, but why shouldn't it exist at all once it is reliable?
Because of "reliable as possible." Generally, medical tests like these will have different rates of false positives and false negatives, something mass market like this will have higher rates of both. Not really a knock against the product, for cost-effectiveness, even in a medical setting some diseases are screened using a cheaper test first and a more expensive test to weed out the false positives.
There will always be trade-offs between cost and accuracy.
Which is really just a long winded way of leading to:
quote:Originally posted by theresa51282: ... This sort of test is something that I would see doing much more good if it was accompanied by a meeting with a health professional.
Which goes back to MrSquicky's post. Someone that leans more toward the former POV may feel that it is important that ambiguous news of potential diagnoses of serious or terminal illnesses best be delivered by a professional that can make sure that the patient really understands the risks and/or situation.
(As a lesser variant of this concept, in Canada at least, morning-after pills are sold OTC with a consultation with a pharmacist)
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Genotype accuracy almost certainly won't be the problem. The problem is in drawing conclusions from the genotypes. In going from genotype -> probability of phenotype. That's straightforward for some genotypes, but not for complicated ones like diabetes.
A recent paper on a guy who sequenced his whole genome looking for the SNPs that caused his phenotype:
He was homozygous for 5 SNPs which were supposed to cause diseases that he didn't have. And he had the disease not because he had two identical copies of a broken gene, but because he had two different broken copies, only one of which was previously known, and isn't enough by itself to cuase the phenotype. So this kind of genetic testing would have told him that he was only a carrier, when he actually does have the full blown disease phenotype.
Scientists are collecting data as quick as they can, from as many people as they can, but the science just isn't at the stage where this data is very helpful.
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quote:Originally posted by Lisa: "Not so sure it should exist at all"? "More good if it was accompanied by a meeting with a health professional"? Whatever happened to letting people make their own choices?
I don't believe a home DNA testing product should exist. I think this sort of testing should remain under the orders and interpretation of a licensed physician and executed by a competent and independent laboratory. My apologies for not being clearer.
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I'm wondering how 23andme.com (and a few other similar services) haven't had similar problems with the FDA. Is it because they don't sell an over-the-counter product?
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quote:I don't believe a home DNA testing product should exist. I think this sort of testing should remain under the orders and interpretation of a licensed physician and executed by a competent and independent laboratory.
What about a service like 23andme.com, where anyone can pay for the test but the sequencing is done by a professional lab? Or is it important to you that the test be requested by a medical professional?
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quote:Originally posted by MattP: I'm wondering how 23andme.com (and a few other similar services) haven't had similar problems with the FDA. Is it because they don't sell an over-the-counter product?
quote:Originally posted by MattP: I'm wondering how 23andme.com (and a few other similar services) haven't had similar problems with the FDA. Is it because they don't sell an over-the-counter product?
quote:23andMe also claims that it’s not delivering medical advice or actual genetic testing. For instance, here’s the relevant part of the site’s disclaimer, which you have to click through during the sign-up process:
"23andMe’s service is not a test or kit designed to diagnose disease or medical conditions, and it is not intended to be medical advice. If you have concerns or questions about what you learn through 23andMe, you should contact your physician or other appropriate professional."
This is clearly 23andMe’s strategy for sidestepping FDA regulation of its service, and it strikes me as a fairly risky play. After all, 23andMe presumably offers you exactly the same information that existing, FDA-regulated genetic tests do (and then some, of course).
posted
I'm aware of the disclaimers - I'm actually waiting on my results right now. I was just curious, given that these companies have been operating for quite a while, why there was a fuss now. Rivka's link was informative.
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quote:I don't believe a home DNA testing product should exist. I think this sort of testing should remain under the orders and interpretation of a licensed physician and executed by a competent and independent laboratory. My apologies for not being clearer.
If it's easy to do and the act of getting the sample for the test and performing the test itself are both totally harmless, why shouldn't such a product exist?
I realize there are dangers involved, but how is this qualitatively different from websites such as webmd, which offers millions of people a month the opportunity to crudely self-diagnose? Slap a big old disclaimer and warning label on the thing, something to the effect of 'false positives happen' and 'this does not make you a doctor!', I say.
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