FDA Regulating Your Stem Cells As Interstate Commerce

New submitter dcbrianw writes "A non-surgical procedure that treats joint pain involves removing stem cells from a patient's blood and reinserting them into the joint. The facility conducting these procedures resides in Colorado, but because it orders equipment to perform the procedure from outside of Colorado, the FDA claims it must regulate this process and that it can classify stem cells as a drug. This issue opens the debate of what the FDA, or other regulatory bodies, may regulate within each of our own bodies." Quick: Name five activities with no possible plausible effect on interstate commerce.

Comments

Commerce maximalists?

[DoofusOfDeath]

Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

Is this simply a perennial sin of the Court, or is there a sound Constitutional basis for it?

Re:Commerce maximalists?

[nschubach]

I was always taught that it was enacted to prevent States from restricting trade between neighboring states... not to prevent trade.

Re:Commerce maximalists?

[robbadler]

I think you misread the article. Biohazardous material will not be crossing state lines, medical equipment will. This is an attempt to stop the use of that equipment on the grounds that it at one point crossed a state line. So did my jeans. Can they use Interstate Commerce to keep me from going to work?

Re:Commerce maximalists?

[Hijacked Public]

No it isn't.

The 'potentially biohazardous material' is contained inside the patient when he boards the airplane to fly to Colorado. That he happens to be going to Colorado to have this procedure performed sets him aparts from the other airplane passengers not at all.

What the FDA is claiming and will probably be backed up by the executive on but possibly not the judicial, is that because the company performing the procedure purchases equipment from other states, their entire business can then be regulated per the commerce clause. This includes their performing the procedure.

It is the same line of thought that had the Clinton administration claiming it could confiscate a person's property simply because that property had once moved across state lines, no matter how long ago and no matter how many hands it had previously passed through, even within the same state. This is an enormous power to give to a government and the very idea that such a tenuous tie is enough to warrant it is insane. SCOTUS rebuked that just a bit recently, but not nearly enough.

Re:Commerce maximalists?

[Anonymous Coward]

This came up in a constitutional law class I took. The answer we came up with is that (1) we (the general populace) want the federal government to be able to regulate these things, (2) constitutional amendments are nigh impossible, and (3) it can be justified... the logic is tortured, and I doubt any intellectually honest person would really believe it, but it can be done.

You probably hate point (1), but think about when it really started happening... the depression was here, people were miserable, they wanted someone to save them, so they turned to the government. And that still happens today. Turn on the news, and when you hear about a major problem, there will be a commentator following hard upon saying "where were the regulators in all of this?!" and people will nod their heads.

Anyway, that's the answer: the majority of people want it to be the way it is.

Re:Commerce maximalists?

[sconeu]

Actually, States Rights are enshrined in the 10th Amendment. The 14th establishes some federal powers over the States.

Re:Commerce maximalists?

[0123456]

Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

Because it's the only way for a power-crazed Federal government to impose their laws across the country.

Re:Commerce maximalists?

[Goobermunch]

Please, please, please. Learn your history.

FDR did not pack the court with statists. In fact, the proposal he had advanced (of adding more justices to the supreme court), never went through. Instead, one justice on the court changed his mind about how to approach these matters and turned what had once been a 4-5 court into a 5-4 court. http://en.wikipedia.org/wiki/The_switch_in_time_that_saved_nine

But go ahead and blame FDR, that's easier than learning about history.

--AC

Re:Commerce maximalists?

[ackthpt]

"No, this is regulating the shipment of potentially biohazardous material across state lines."

A curious theory considering nothing in the article mentioned transporting stem cells across state lines.

Well, suppose your culture grows out of control, into some hideous monster, which would even give J. J. Abrams the night terrors and start roaming the country side? They'd have a point then methinks.

My Creature Was Monster Of The Month In Tokyo

Re:Commerce maximalists?

[SaroDarksbane]

Can they use Interstate Commerce to keep me from going to work?

They can use the Interstate Commerce clause to prevent you from growing wheat in your own backyard for your own consumption, so . . . yes? And it's obvious why the courts let them get away with this; like any good statist, the courts also want the government to control your life at every level. Judges really have the easiest job in the world of it, though, since all they have to do is say "Whatever the government wants is cool with us".

Re:Commerce maximalists?

[hey!]

I was always taught that it was enacted to prevent States from restricting trade between neighboring states... not to prevent trade.

Nobody advocates regulation to *prevent* trade in general. Some trade is *always* restricted by regulation, but the intent and effect of the regulation may be to encourage trade overall. For example if there weren't federal standards for auto emissions, more states might follow California's lead and develop their own regulatory standards. By establishing a nation-wide regulatory regime, a larger and more efficient market results.

On the other hand federal laws *do* effectively prevent *in state* trade in recreational drugs. If anything that's much *more* of an overstepping of federal powers, because the intent is not to provide a uniform regulatory regime for trade in recreational drugs across the country, but to *forbid* the use of recreational drugs *anywhere*. It's seldom questioned because both major parties agree that recreational drug use should be forbidden everywhere.

This is Commerce Clause of the US Constitution: "[Congress will have the power] To regulate Commerce with foreign Nations, and among the several States, and with the Indian tribes. That's it. That's all there is. The plain text of the clause doesn't simply prevent Congress or the States from restricting trade to favor one state's produce over another (that's actually covered in Article 1, Sections 9 and 10). The clause appears to give Congress power to regulate interstate commerce *for any reason it sees fit*. If so, Congress can intentionally *restrict trade* between the states if it believes that trade is not in the national interest. And it does, and will continue to do so. If there's ever successful nation-wide restrictions on abortion, those restrictions will be made possible by the Commerce Clause.

You could reasonably argue that this is *too* much power to give Congress. It wouldn't be the only case. I think the powers the Constitution grants Congress in copyrights and patents almost certainly enable Congress to pass laws that would be repulsive to the framers. But the framers while intending to create a government with circumscribed and carefully enumerated powers couldn't possibly have anticipated *all* the uses to which any one power could be put.

Re:Commerce maximalists?

[sjames]

By that, he does not mean advocates of state's rights, but statists as in believing in the supremacy of 'the state' over individuals.

Other than the recent narrow ruling requiring a warrant for some GPS tracking, they do seem to have a distinct statist leaning.

Re:Commerce maximalists?

[honestmonkey]

You know, I don't see ANYTHING in that statement that precludes stems cells turning into a horrible monster that then roams the countryside, perhaps even leaving Colorado! I think the FDA might want to know if this happens and, thus, control it. The FDA appears to be only thinking of us, and trying to protect us form gross abominations of nature that might be coming to harm us. And it sounds like you don't want this. Which makes me wonder if you're a terrorist. Are you using a VPN or Tor? Hmmm? Maybe the FDA wants to know that as well.

Re:Commerce maximalists?

[tnk1]

Mostly because the state governments are closer to the people they represent, and are probably (slightly) more concerned about the welfare of the individual people they represent. Obviously, some state governments are pretty huge too, so that is going to be admittedly relative. Still, the Federal Government is gigantic, and you will often find that it tends to represent only the key groups for getting elections won, which is ultimately a very small number of people when you consider it.

I think the best form of democracy consists of the most local form that can get the job done. Having a national army on the Federal level is going to be necessary to protect the whole country from larger aggressors, and certainly it is a bad idea to have localized foreign policy, but do we really need the Federal government to synchronize education, for instance? I'd say not, and the arguments that I hear from some people along the lines of "we can't let the hicks stop teaching evolution," or the like, I think is an invalidation of the principle of government by the People. I also feel that such polarization starts happening when individuals feel they need to become more and more radicalized to even be heard in the larger governmental venues.

Having government at a local level does not always prevent corruption, but it does allow people to actually have a chance to have a say in government if they try to exert their will and interest. To even be noticed on a state and Federal level, you start needing the massive cash reserves that only things like special interest groups or corporate sponsorships can get for you. There's less diversity in solutions, and they tend to be executed more on a basis of political expediency rather than need or efficiency.

Re:Commerce maximalists?

[atriusofbricia]

I would also note that the interstate commerce clause is used as justification for the Obamacare individual mandate.

Everything that isn't explicitly authorized by the Constitution is claimed to be found in the virtually infinite ICC or GW clause.

EPA, War on (some) Drugs, FTC and probably a dozen more federal agencies. Whether a person likes them all or not, they're all tied directly to the infinite power interpretation of the ICC (or GW).

Re:Commerce maximalists?

[atriusofbricia]

Can anyone comment on why the Supreme Court has historically allowed the Commerce clause to apply to absolutely anything that could be remotely, however ridiculously, be considered related to interstate commerce, and thus trample states' rights?

Is this simply a perennial sin of the Court, or is there a sound Constitutional basis for it?

I certainly cannot, since the states rights are enshrined in the 14th amendment and the commerce clause is in the original constitution, it has never made sense to me. The amendments are supposed to supercede the consititution. That's the whole point of having them.

Point of order... States do not have Rights. States have Powers, People have Rights. :)

Re:Commerce maximalists?

[evil_aaronm]

http://en.wikipedia.org/wiki/Wickard_v._Filburn

Interstate Commerce

[mosb1000]

I think maybe where they've gone off track is they are thinking they can regulate anything related to interstate commerce, rather than just the commerce itself.

DMT

[Hatta]

Dimethyltryptamine (DMT) is a naturally occuring endogenous neurotransmitter that is also a Schedule I drug.

this is hardly the biggest abuse

[Karmashock]

Interstate commerce is a catch all the government uses when it has no right to do something and wants to do it anyway.

What I find amusing about this is that so many people are upset about this stem cell thing but aren't upset by all the things that created the precedence that allowed them to make these claims in the first place.

if you want this to stop then the inter state commerce clause needs to get it's wings clipped. That's the problem. Go to the source.

Growing your own food affects interstate commerce

[Anonymous Coward]

If you grow your own food, you won't buy it from another state. Therefore, growing your own food affects interstate commerce. At least that's what the Supreme Court decided when a farmer fed his own animals with his home grown food.

http://en.wikipedia.org/wiki/Wickard_v._Filburn

Re:So?

[ClioCJS]

Uh, no. That's not how medicine OR the FDA works. They don't regulate medical procedures throughout the country. They have a specific scope. But i guess you weren't too sure of yourself if you had to post anonymously, were you?

A modicum of facts

No such thing exists

[NovaSupreme]

You cannot do anything without having some effect on interstate commerce.
Entropy of whole universe must increase with time, so everything is connected including interstate commerce and your poop.
Alternatively, if you are alive and you breathe, you must be changing composition of air a little bit, and since all air is connected, you are modifying the air composition of the whole country. This promotes traders who sell purified air across states.
Alternatively, if you buy an out-of-state merchandise, of course you impact interstate commerce. On the other hand, if you dont buy from an out-of-state merchant, of course you impact interstate commerce, as your (lack of) activity will have negative effect on the price of the merchandise.

Oh, this would be so funny if this clause were not the most abused clause in the constitution, that has been taken WAAAAAY out of its context.

Hahahahahaha

[roman_mir]

This is precious, why have a Constitution if you can 'interpret' it at all, so in reality nothing that government wants to do can be prevented?

I mean, eventually you BREATH AIR, right? Doesn't air cross State boundaries? That's it - your very existence can be regulated by the federal government completely even if you never leave your particular State.

If you grow your own food in your own garden and you don't even buy anything from anybody - well, by gov't logic (and it's true, it already was argued) you are involved in 'interstate commerce'. Why? Because you aren't buying things from other states, so you are clearly preventing their sales, which means you are interfering with inter-state commerce, which means you are engaged in it.

Hawaii is one state, yet it has 'interstate highways' in it (H-1), but it's one State. So how is that possible? Well the answer is obvious - when federal government wants to build a highway system in order to interfere with States rights logic exits the doors.

Re:Growing your own food affects interstate commer

[Daetrin]

It's the government's "get out of jail free" card to regulate anything they want. If you're doing something involving interstate commerce, clearly that affects interstate commerce. If you choose to avoid doing anything that involves interstate commerce, well then obviously that intentional lack of interaction has an effect on interstate commerce as well!

... Glenn Beck on Slashdot?

[truavatar]

Glenn Beck's "theblaze.com" is your sole source for this front page post? Thanks slashdot.

Re:... Glenn Beck on Slashdot?

[gewalker]

I don't care whether it comes from theblaze, huffpost , the national enquirer, or the KKK. If the the story is accurate and relevant (sufficiently interesting, funny, etc.)? If yes, the front page is fine by me. If you have a choice of sourcing the article, a less incendiary source would be a wiser choice.

Re:... Glenn Beck on Slashdot?

[truavatar]

It is not accurate. That is my point.

theblaze.com's sole source is the Alliance for Natural Health's article which grossly misrepresent the FDA's case, as you can see if you read the FDA's motion for summary judgement:

http://www.hpm.com/pdf/blog/GovernmentSupportforSummaryJudgmentMotion.pdf

The article is about as useful as if it had come from the National Enquirer.

Re:... Glenn Beck on Slashdot?

[geekoid]

It isn't. It's twisted and incorrect.

For the record; when a source has a history of twisting, lying, and making things up, they loose any credibility. I don't want to see them on the front page. By changing their ways, they can earn front page.

Re:So?

[SydShamino]

That's a really bad argument. The Supreme Court can be and is regularly wrong. Their word may be law, but that does not make their work right and everyone else wrong. Big difference.

Taking this a a logical (I hope) conclusion...

[aklinux]

I suppose this means that now I will need FDA approval before inserting sperm into a womans body?

It is not about commerce and stem cells

[pesho]

This is a moronic summary of a stupid article. This is not about FDA regulating your stem cells, it is about FDA regulating snake oil salesmen, before somebody gets hurt.

Some schmuck finds a loophole in the law that allows him to perform for profit untested medical procedures with questionable (to put it mildly) outcome. FDA has two options:

1. Ignore him and when somebody gets hurt get dragged to congress as a showpiece of a useless government bureaucracy.

2. Cover their bases and use all (no mater how questionable) authority that it can muster to try to shut him down.

Option one is a loosing proposition. Option two is a win-win no-matter how the court decides. If the court allows this to fly (unlikely) they win. If the court laughs at their arguments (more likely) they have covered their asses big time. Now they can turn to congress and say 'We have done what we can, it is your turn now to decide if this should be regulated'. In addition, at any point in the future when a similar situation pops up they are absolved from responsibility.