FDA Overreach

by on June 12, 2010 at 7:28 am in Current Affairs, Law, Medicine | Permalink

From the Washington Post:

The Food and Drug Administration on Friday ordered five companies that offer genome-sequencing tests to consumers, or that provide the scientific services for them, to prove the validity of such products.

The FDA said the tests, which scan a person's DNA for gene variants associated with specific diseases, are medical devices requiring the agency's approval.

The ability of genetic tests to predict diseases is currently limited; if the FDA were simply to require firms to acknowledge this point, say with a clear statement of probabilities, that would be one thing (although this task is better met by the FTC under advertising regulation).  But the FDA is brazenly overreaching in trying to regulate genetic tests as medical devices. First, there is no question that these tests are safe–safer than brushing your teeth!–and also effective in identifying genetic markers.  Thus, there is no medical reason whatsoever for regulation.

Moreover, genetic tests provide information, personal information about our bodies and our selves.  The FDA has no standing to interfere with the provision of such information.

Consider, I swab the inside of my cheek and send the sample to a firm. The idea that the FDA can rule on what the firm can and cannot tell me about my own genes is absurd–it's no different than the FDA trying to regulate what my doctor can tell me after a physical examination or what my optometrist can tell me after an eye examination (Please read the first line.  "G T A C C A…").

The idea that the FDA can regulate and control what individuals may learn about their own bodies is deeply offensive and, in my view, plainly unconstitutional.

Ben June 12, 2010 at 8:03 am

I think you’re being too harsh here. It seems that the FDA’s responsibilities do include making sure healthcare companies “prove the validity of such products.” Whether these are medical “devices” or not may be debatable, but the underlying medical science involved is not. Evaluating medical claims is definitely under the jurisdiction of the FDA (look at vitamins and supplements that bear the phrasing “these statements have not been evaluated or approved by the FDA”). If the FDA finds in their evaluations of the tests that the companies are misrepresenting their products, then I’m fairly certain you’ll see something from the FTC regarding associated advertising.

Doug June 12, 2010 at 8:36 am

Can the FDA regulate X-rays, PET-scans, ultrasounds, tomography / tomographers, blood exams, diabetes exams, HIV tests? If so, it can “regulate and control what individuals may learn about their own bodies”, easy easy.

Andrew June 12, 2010 at 8:40 am

Clearly, the FDA doesn’t get to regulate whatever the freak they want to. Not logically anyway. Personal use devices do not perform a medical invervention, so I’d say there is no rationale whatsoever for FDA to regulate. Aside of course from the rationale everyone knows, that they want to regulate everything, and that there are people who support such nonsense, and unfortunately we let people from California decide such rules for all of us.

The validity of the tests will be proven when people keep buying them after they validate the results against other tests. There is no medical risk involved.

Andrew June 12, 2010 at 8:54 am

If so, it can “regulate and control what individuals may learn about their own bodies”, easy easy.

No. Just because it can regulate some devices that provide information,that does not extend to a rationale to regulate all information from any source.

The FDA’s rationale is that people may use the information to make medical decisions (well whooptee doo). I also use my brain and eyes and the internet to make medical decisions. The FDA is not justified to regulate those.

Andrew June 12, 2010 at 9:10 am

bbartlog

People aren’t going to make medical decisions based on this information. They will make better decisions in consultation with a doctor with the information. Therefore, the risk is on adding any additional cost or lack of access to the information.

I work in the implant/device industry and some day I’ll take up this issue that the FDA is safe, effective and competent. Rarely does a day go by that someone has to re-think an idea and use a less-than ideal material because it is “FDA-approved.” You could go ahead and get your novel material approved, since it is superior, but the cost is prohibitive to do so. Noone will touch it.

Robin Hanson June 12, 2010 at 9:19 am

Well they do regulate who is allowed to give you an eye exam. Not just anyone is allowed to tell you that if you can’t read the letters on the chart your eyes might not be up to par. That process also has zero risk of direct harm to you, and merely provides info.

J June 12, 2010 at 10:01 am

The standard that a medical product only can be regulated for safety disappeared in the 1960–you know that. Birth control tests don’t involve any direct “safety risk” but it’s not hard to see how false or misleading results could have a substantial negative impact to public health.

I think the real issue is that FDA wants to be able to regulate what the language is that a company can use when it presents the results of these tests (which is where the bulk of their power in the device world comes from anyway–a substantially lesser burden than drugs). Since the results of these genetic tests will be read largely without the input of a medical professional, the potential risk of misinterpretation by the consumer, resulting in ill-informed personal health decisions, seems high.

Yancey Ward June 12, 2010 at 11:26 am

Rahul is correct, all this would do is force the testing overseas. Will the FDA regulate FedEx and the internet?

Does the FDA regulate medical diagnosis books or online medical diagnosis sites? Do they regulate Good Housekeeping’s diet recommendations? I am with Andrew and Alex on this one- at the very least this should logically be outside the scope of the agencies reach. If it isn’t, nothing is.

Yancey Ward June 12, 2010 at 12:41 pm

Lord,

If some in the industry welcome it, then they should voluntarily offer their products for a “stamp of approval”. If they don’t want to pay for the stamp, should they be put out of business?

Careless June 12, 2010 at 1:48 pm

It might be offensive, but unconstitutional? What provision of the constitution does this violate?

You have it backwards. The question is “what gives the government the power to do this?”

Mario June 12, 2010 at 2:49 pm

If you want a more accurate example of the government controlling what individuals may learn about their own bodies, look at Complete Blood Counts. You need a doctor’s permission (and fee, naturally) to get one, even though the act of taking the blood can be done by just about anyone. Taking a blood sample: almost completely unregulated. Running that sample through a machine: highly regulated. It’s unjustifiable.

Mike Huben June 12, 2010 at 3:26 pm

The idea that the FDA can regulate and control what individuals may learn about their own bodies is deeply offensive and, in my view, plainly unconstitutional.

Alex here makes presumptions that the products actually work, that they are sufficiently accurate, that users of the test understand the possibilities of false negatives and false positives, that the users are able to interpret the results of the test in some valid way to infer presence, absence, or likelihood of disease, etc.

As we see in unregulated industries such as herbal supplements, it is entirely possible that there is no efficacy and indeed sometimes none of the supposed principal ingredient. It is MUCH cheaper to bring a harmless fraud to market than to develop something new and sophisticated that does work.

The FDA is not regulating what you’re learning about your body: it is watching out for fraud and incompetence, traditional problems in medicine. Presumably even libertarians like Alex should care about fraud and incompetence. And fraud is something the federal government is constitutionally empowered to deter.

Tim June 12, 2010 at 5:12 pm

“People aren’t going to make medical decisions based on this information. They will make better decisions in consultation with a doctor with the information.”

If only that were true. What’s actually going to happen is that people are going to get their “diagnosis” from a genetic test and then insist that their doctors treat them based on that. When the doctor does a physical exam and more lab tests and decides treatment isn’t necessary, will these patients agree with their doctor’s judgement? Nope, they’ll just go doctor-shopping until they find one who’s willing to treat them how they want.

jbarrett June 12, 2010 at 6:25 pm

From the original post: “The Food and Drug Administration…ordered five companies that offer genome-sequencing tests…to prove the validity of such products.”

That the FDA seems to be concerned with the validity of the tests really goes to the question of whether the test are, or are not, fraudulent; in contrast, say, to asking a manufacturer to prove the efficacy of a drug or treatment. I see this as being a question of the role the FDA is playing; is it acting as a regulatory agency or as a law enforcement agency? In asking for proof of validity the FDA really is engaged in policing against fraudulent representations, as opposed to regulating products and treatments. If they are acting to deter fraud they are no different than your local PD. The problem with the FDA acting as a law enforcer here is that they are asking companies to come on in and prove their innocence. That turns the idea of presumed innocence on its head. If there is criminality in the representations of the testers let the FDA find it and then act to bring any offending companies to justice.

John Thacker June 12, 2010 at 9:43 pm

What’s actually going to happen is that people are going to get their “diagnosis” from a genetic test and then insist that their doctors treat them based on that. When the doctor does a physical exam and more lab tests and decides treatment isn’t necessary, will these patients agree with their doctor’s judgement? Nope, they’ll just go doctor-shopping until they find one who’s willing to treat them how they want.

But Tim, even granting that, there’s still an advantage with these tests being legal. After all, if people are going to go doctor-shopping, then without these tests being legal they’ll go doctor shopping until they find one who’s willing to perform these tests first, then get treated based on that.

You might as well have people bear the full costs of these tests, and have these tests done without expensive doctors involved, then have extra doctor-shopping done and covered under insurance.

I’ve always felt that most of the arguments saying that one ought to require a doctor’s permission break down in the face of doctor-shopping. Surely this one does too– if you ban these, then people will just doctor-shop until they can get tests done by some doctor.

Bernard Yomtov June 12, 2010 at 10:17 pm

Well they do regulate who is allowed to give you an eye exam. Not just anyone is allowed to tell you that if you can’t read the letters on the chart your eyes might not be up to par. That process also has zero risk of direct harm to you, and merely provides info.

I don’t think this is quite true. Anyone is allowed to tell you that, as you just did. The potential for harm arises when the examiner starts specifying whether glasses would be helpful, and how the lenses should be made.

rjh June 13, 2010 at 4:17 pm

If Alex’s description of returning a genetic sequence were true, I doubt that the FDA would be involved. But, that is not what is happening.

The results of these tests include statements like “You have 3 times the normal odds of getting disease X”. That is a diagnosis. The FDA is saying that the vendors must provide good scientific evidence for making that statement.

This is much more like dealing with potential fraud. They are making a great many statements in their reports. The purchasers have no way of assessing the accuracy of those statements. The FDA has the regulatory charge of ensuring that medical diagnostic results have a reasonable scientific basis. So far, they are just demanding that this scientific basis be provided to the FDA for review.

I suspect that there will be problems. The 2006 GAO report found substantial errors in the testing. They took multiple vendors, send samples from the same person to each vendor, and got substantially different reports for the same person. Things may have changed, but that is a warning sign. I’m sure it influence the FDA decision to request documentation for the scientific basis and methodology of the tests.

The CLIA law concerning accuracy and procedures for medical laboratories will also apply when these reports include diagnostic claims.

David June 14, 2010 at 3:26 am

This is really nothing new. FDA has always regulated clinical testing, everything from sticks used to estimate urine glucose to cholesterol tests. Reputable companies routinely collect data on the accuracy and precision of their test methods. If these DNA companies are not collecting such data, I would assume they are mostly racketeers, trying to make money off of a fad.

You say the tests are safe: but if someone falsely tells you that you are at high risk of a disease, there are bound to be emotional as well as tangible costs. If a patient reacts aggressively to such genetic data (think prophylactic mastectomies), there could be serious consequences to inaccurate testing.

You could take the libertarian view that all such regulation is an improper interference in the market. But it is REALLY HARD for a layman to evaluate the data on effectiveness, safety, or accuracy. Most of us would prefer to hire (through our taxes) some experts to evaluate this data for us.

chris June 14, 2010 at 9:28 am

If post-hoc fraud suits were enough to shut down snake oil salesmen, the FDA would never have been created in the first place. Why does it seem that most conservative or libertarian critiques of a government agency are written from a position of total ignorance of the history of either the agency or the problems it was created to address?

Those who cannot remember the past shouldn’t try to doom everyone else to repeat it.

William Barghest June 14, 2010 at 11:39 am

@chris

I am not sure the baptist and bootlegger story of the creation of the FDA or the reform minded citizens insist on good government to solve obvious problem story is more credible. But to answer it we need to know if snake-oil was really a problem. Is there any data at all?

Mark June 14, 2010 at 1:21 pm

mulp writes “….seems to be arguing that I should be allowed to offer a test that will determine whether you have HIV, any of the strains of hepatitis, and a long list of communicable diseases without any evidence the test works. And if I can do this comprehensive test for $10, then that is the free market at its best.”

(minor point, Mulp – Alex not Tyler for this one)

Major point: isn’t the FDA simply assuring that these tests actually do what they say? And as to medical device, if they regulate HIV tests, then clearly they can regulate DNA sequence testing.

I’d like to urge thinking about the health care implications of all of this: I get a DNA test (in the near future, complete sequence), I see some “mutation” and I schedule a doctor’s appt immediately to evaluate things.

Talk about health care cost increases!!!

John Thacker June 14, 2010 at 2:40 pm

BTW, it’s inaccurate to say that the herbal medicine market is “unregulated.” It’s actually regulated in a fairly perverse way– it’s actually illegal for manufacturers to perform and report on any sort of effect for their products in a scientific fashion. Doing so would invite the FDA to smack them down for not clearing it with them first. This means that snake oil manufacturers actually have a bigger advantage in the herbal market than they would absent the FDA.

Steko June 14, 2010 at 8:42 pm

“The idea that the FDA can rule on what the firm can and cannot tell me about my own genes is absurd”

Straw man alert, awooga. What the FDA is doing is making sure you’re not being defrauded. They don’t let drug companies sell sugar pills to fight cancer, they also don’t want to let genetic test companies sell inaccurate genetic diagnoses. I realize you don’t want the government to do that, but I just like I don’t want my neighbor to mow his lawn at 9am on Sunday that doesn’t make it “unconstitutional”.

seo firm August 23, 2010 at 1:22 am

A problem with the voluntary genetic testing is that people can use this information to improve their health insurance. They create an asymmetry of information. If I find I have three times as many chances for disease X, and my insurance company did not know that I might be able to refine my policy to my advantage. If my genetic test shows that I am a relatively low risk, I can choose a higher deductible, etc. A problem of adverse selection is created. Now that the government provide health insurance, do not be surprised if most of the early issues of attracting the attention of the FDA.
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