The Glade 4.0

While the FDA inspections aren't worth much, at least with the FDA and its regulations you can actually do something to people who intentionally sell crap food and drugs, when they get caught. The FDA doesn't have to be the one that catches them, but at least penalties exist. Without the FDA, you're can't really do anything to a company that does this other than not buy from them. The best you can do is sue the company, which will never be effective as the owners will just loot the corporation and run, leaving you with all the court and lawyer fees with nothing to show for it. Then they'll restart the process with a different name, probably utilizing the same production facilities and same management. Corporations ALREADY do this, if you do something horrible that makes everyone hate your brand, just change the name. Or buy out a small company that has a decent brand name, do a reverse merger, and take their brand, changing nothing.

As long as it's not an actual crime to label and sell certain things as food or drugs, there's nothing you can do about it. And if you're going to have these regulations, you need a government body that drafts and implements these regulations.

That situation exsists right now with firearms. In Pennsylvania I can open carry a firearm with 15 hollow point bullets. If I walk over the boarder to NJ I am now committing at least 17 felonies. I must know the laws of where I am. What's legal in PA suddenly becomes illegal one inch into NJ.

So why in the case of firearms can a state make its own rules and in the case of something that affects far more citizens, its opinion is restricted?

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A man who has nothing for which he is willing to fight, nothing which is more important than his own personal safety, is a miserable creature and has no chance of being free unless made and kept so by the exertions of better men than himself. ~ John Stuart Mill

Qwest = Century Link, Same crap different logo

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History of the Condom
In 1272, the Muslim Arabs invented the condom, using a goat's lower intestine.
In 1873, the British somewhat refined the idea, by taking the intestine out of the goat first.

Different nations have different standards bodies ... You have the same issues overall with that? If Ohio wants to play hard ball, then there are other states that will gladly step in, seems that the market would be free to compensate for the problems you imagine

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In time, this too shall pass.

States rights exist for a reason. Granted a few things should be over seen by the fed, as outlined by the Constitution.
Everything else should be left to the states.
Don't like your states laws, move there will be winners and losers.

What I love are the Asshats from Ca. that move to Az, because of the laws, then they piss and moan Because were not like Ca.

It should be legal to thin the herd when they start whining.

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History of the Condom
In 1272, the Muslim Arabs invented the condom, using a goat's lower intestine.
In 1873, the British somewhat refined the idea, by taking the intestine out of the goat first.

I have to say, there are some phenomenal gaps in logic being displayed in this thread. So here's a couple things that might help.
1) There's a difference between a standards body and a regulatory body, and
2) Snake-oil salesmen were successful in large part because they were faster than the news.

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Standards bodies are often empowered to become de facto regulatory bodies. INPO can give violations which don't mean anything but are still serious.

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"It's real, grew up in trife life, the times of white lines
The hype vice, murderous nighttimes and knife fights invite crimes" - Nasir Jones

So morality and respect are universal?

Except it is not the same, you do not need a passport, don't need to learn a foreign language and don't need to save over 1k for an airline ticket. An analogous situation to me is gambling. How many bus charters run to Indian Casinos/Atlantic City/Las Vegas? Once you lower the price of admission you get a lot more bodies in the door.

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They don't have to be universal - they just have to exist in near the same quantity that they do now and you haven't shown why this would change simply because the law would.

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"...but there exists also in the human heart a depraved taste for equality, which impels the weak to attempt to lower the powerful to their own level and reduces men to prefer equality in slavery to inequality with freedom." - De Tocqueville

You guys totally missed the whole point of having a regulatory authority for medicine. It is not there to protect the user from themselves, but to assess the benefit vs risk of any medicine.

While I agree the FDA in it's current situation is not very efficient compared with the rest of the world. However compared with un-regulated countries, the US is still a lot safer in terms of food and drugs.

Keep in mind that any regulatory body does not simply test and audit manufacturer's in their own country, but must do so for manufacturer's all over the world, their work load often accounts for their long turn over period. Placing this huge regulatory burden on the states would be un-realistic.

Individual U.S. states have economies larger than most countries, including many developed ones. California and New York are in the top ten, I believe. The idea that individual states are not capable of regulating food and drugs is patently ludicrous, unless you also mean to suggest that countries such as Germany and France, or maybe Australia, are also not capable of doing it.

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Buckle your pants or they might fall down.

I didn't say the individual states were not capable. I said it was un-realistic.

The regulator's job is divided into 3 sections.

1) Pre-market inspection, this includes inspections of overseas and in country manufacturers. While ISO certification could show some compliance, most regulators prefer to use their own auditors for high risk products (such as blood screening tests or certain prescription medicines).

2) Drug/test assessment. This includes validation and verification data, as well as any clinical trials run.

3) Post market surveillance. This includes marketing material, labelling standards, tracking of medical incidents, re-certification, etc.

Doing each of those things 50 times would just be a waste of (in the US case) tax payer's money. If you had a national database and a single standard to which all states abide by, it's no different to having a FDA. Thus regulation at a state level is un-realistic.

This would be true if they were independent countries that could come up with agreements with other countries. The Constitution, however, forbids agreements of the sorts that would be necessary between the states for them to do so in a meaningful manner. The only thing that's ludicrous is trying to simplify it down to the size of the economy in question.

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"Hysterical children shrieking about right-wing anything need to go sit in the corner and be quiet while the adults are talking."

I'm not following you. What kind of agreements are you talking about? It's true that Arkansas can't make a trade agreement with New York, but I don't see what that has to do with regulating food and drugs. States can regulate or outright ban the sale, purchase, and/or production of specific goods and services within their own borders, and do so all the time. Take for instance the trans fat bans in various locales. In fact, almost all of those -- except the CA restaurant ban -- are at the local city/county level rather than state level (although cities and counties are chartered by the state FWIW).

Edit:
Or, as another example: salvia. Legal in some states, illegal in others. It may be a recreational rather than pharmaceutical drug, but it still demonstrates that states can regulate drugs without running afoul of interstate commerce.
/Edit

There is the matter of "full faith and credit", of course. A state can't regulate what its own citizens do while in another state. However, I don't see how this is real, practical problem any more so than it is for fully independent nations. On paper, the United States can (and does) declare that it is illegal for one of its citizens to do X even if they do it in Germany, where X is legal. But in practice, such laws are basically impossible to enforce anyway. The fact that a person could travel to another state to undergo treatments which don't meet their home state's regulations is not any more problematic than the fact that someone living in France could do the same in Sweden.

States can still outlaw the use and/or possession of specific drugs within their own borders, so you can't undermine that by buying drugs in another state and bringing them back home. Well, not legally, anyway. Of course, people can do it and probably will. But how is that any different than the current situation where people buy drugs in Canada and illegally bring them into U.S.? That kind of thing is an enforcement issue that will exist no matter which level of government is doing the regulation.

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Sail forth! steer for the deep waters only!
Reckless, O soul, exploring, I with thee, and thou with me;
For we are bound where mariner has not yet dared to go,
And we will risk the ship, ourselves and all.

Yes, they can create the regulations. However, you then end up with 50 different sets of regulations to be complied with, and 50 different state regulatory agencies to be dealt with. More importantly, what's the governing standard? The regulations of the state where the food or drug was produced or the one where it's sold? Or both? What if a state that just happens to be along the route decides it wants to regulate what can be shipped through.

The criticism is not that it's somehow physically impossible to create the regulations, its that with 50 different entities all creating their own regulations, you just create a bigger mess. So far I have seen no argument that shows any real reason to believe state-level regulation would actually be better in terms of efficiency or effectiveness. It's simply criticism of the Federal government and saying "well, let the states do it" as if anything done by the states is automatically more efficient or effective. This is not the case; commerce is not like education. Education is accomplished almost entirely locally; we don't ship kids en masse from one place to another to educate them, and therefore local control of education works far better than Federal, and at far less cost. The same would not apply to regulation of food and drugs.



That isn't something I was concerned with anyhow, so I'll leave that be.



Yes, but it is far better to have that only occur at one level (entering and leaving the country) than at both the state AND the Federal level, unless now you're going to suggest the Federal Government shouldn't regualte imports from foreign countries either, which is pretty much explicitly it's purview and responsibility. Moreover, you would now have a morass of such regulations between all 50 states, where re regulations for taking potatoes from Idaho to Arizona could differ completel from those involving taking them from Maine to Virginia.

This idea that there's going to be some sort of miraculous improvement if we have state agencies regulating... interstate commerce, which is also the purview of the Federal Government is just baffling. There seems to be no argument in favor of it other than simply "it shrinks the Federal government!" I'm all in favor of shrinking the Federal government, but not at the expense of creating a worse problem, and there would be worse problems. Everything will not suddenly be hunky-dory because the Federal government is not involved.

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"Hysterical children shrieking about right-wing anything need to go sit in the corner and be quiet while the adults are talking."

DE is correct on this one. There are sorts of mutual recognition between drug and to a smaller extent food between the regulated countries. These include Europe, Japan, Canada, USA and Australia. (Sometimes other countries join too depending on the type of products)

What I mean by sorts is these things are not equal across the different countries. E.g. a CE certificate (issued by European regulators) would be acceptable as evidence of conformance for low risk drugs/medical devices in Australia, however it is not recognised in reverse, but it does make registration easier. A CMDCAS certificate (issued by Canada) is accepted as evidence of conformance for low risk drugs/medical devices in the US and removes the need for the FDA to do a full conformity assessment, however Canada does not place any weight on an FDA approval.

These mutual recognition are discussed on a country level and the type of medicine. (there are currently, OTC, prescription, complementary, medical devices, Invitro diagnostics). And each requirement is different and discussed by a different branch between the countries.

e.g. for medical devices, currently there is the GHTF. http://en.wikipedia.org/wiki/GHTF

Is there something wrong with only enforcing a federal standard on items being shipped internationally?

Even the link you provide is made up of voluntary contributors. I'm sure things like that wouldn't just up and disappear.

To address several points that were just raised:

I can't speak for everyone, but I'm certainly not trying to say that state-level regulation would automatically be "better" than federal-level regulation. In fact, my expectation is that some states would do a worse job, and some would do better. That's somewhat the point of the exercise, actually. The only way to honestly ascertain what kind of regulation works best (whether in relation to food and drugs, health care, or anything else) is to actually try it a bunch of ways and see what happens. But federal-level regulation is, by its nature, homogeneous. Consequently, we get a whole lot of talking heads bickering about what will work best, but very little actual data to make that determination. With a diversity of regulation, it should be possible to directly observe over time which states' systems actually work the best. Eventually, I would expect the various states' regulations to settle towards a fairly common set of policies that have demonstrably worked better than others.

I think that homogeneity in government is generally a bad thing. Especially homogeneity across very large populations. People are simply not homogeneous, and the larger the population is, the less desirable it is to treat it is if it were. Uniformity's only upside, really, is that it may be more efficient than diversity. The efficiency argument is a fair point, but I think there are several counter-points worth considering:

One, efficiency isn't the end-all-be-all of regulation. That's not to say that it shouldn't be given any consideration -- clearly it should -- but it's not the only important factor, nor necessarily the most important one. It's important only inasmuch as less efficiency usually translates into greater cost. However, it might be the case that giving up a little efficiency is worthwhile if doing so purchases something of greater value. See my argument in the first paragraph. Additionally, I feel like I need to reiterate my argument that The One Best System likely doesn't exist. If, for instance, a majority of people in a state are dissatisfied with the way food and drugs are regulated, should they be forced to comply with that system simply because it is more efficient? If they would be happier with a different, but less efficient system, why should anyone stop them? A state government is in a much better position to shape itself to the actual desires of its constituents than the federal government. That's not a slam on the federal government; it's just the nature of the beast. Federal things are federal: your state's constituents are not its only concern.

Secondly, it isn't necessarily the case that diversity would be less efficient than uniformity. Having 50 different systems might be less efficient in some respects, but it is likely to be more efficient in others. As I've said, people are not homogeneous. Neither are markets nor really anything else about the underlying subject of regulation in this case. The price system is far more efficient at assessing value and lubricating economic transactions than any centrally planned system precisely because it is not uniform and therefore can take advantage of local knowledge and conditions better. Similarly, a more granular approach to food and drug regulation may produce more efficient results than a federal system because it better accounts for the local conditions. This may well be enough to offset loses in efficiency due to increased overhead for multi-state businesses and so on.

I also think that the potential diversity (and therefore presumed inefficiency) is being overstated -- at least in the long run. I've already outlined one reason that I believe a state-regulation system would ultimately settle into substantially similar systems. Additionally, I should point out that there's no reason to believe that the individual states, in pursuing their own regulation, would be incapable of making pragmatic considerations, and would chose to adopt regulations so radically different from one another as to be unworkably inefficient. That certainly hasn't been the way of things in other areas. Case in point: no one regulates the underlying technologies that make up the Internet and its many services and protocols (ex. HTTP, SMTP, HTML, etc., etc.). And yet, standards have not only coalesced, but have by and large been adopted (to a reasonable degree) world-wide. Not because someone forced them to from on high (no one is going to come arrest you because you sent a malformed HTTP request), but because people, left to their own devices, are actually quite capable of seeing that cooperation has value which may mitigate the value of individualism.

Finally (I think...), Corolinth's point needs to be repeated, because I feel it was dismissed out of hand. Given the at least comparable population and geographic size of individual U.S. states to European nations, the idea that state-level regulation is too granular to be efficient is suspect at best. Lydiaa offered an explanation as to why she thinks it's more workable in Europe, but I see no reason why the same sort of thing wouldn't happen in the U.S. if it were deemed beneficial to do so. States adopt other state's policies, or mutually adopt a set of policies developed by some independent body all the time. For example, many (most?) state highway departments have adopted the AASHTO design standards more or less wholesale. This doesn't constitute an interstate treaty, and isn't unconstitutional. I don't know why people think food and drugs would be automatically different somehow.

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Sail forth! steer for the deep waters only!
Reckless, O soul, exploring, I with thee, and thou with me;
For we are bound where mariner has not yet dared to go,
And we will risk the ship, ourselves and all.

I would say to this (since it seems to be the crux of the matter) that really, efficiency is pretty much the only major consideration as long as the drugs and food are actually getting shipped and sold.

I don't know in what respect 50 different systems could be more efficient than just one, especially when each of those 50 systems must interact to one degree or another with all 49 other systems.

I also do not see that the homogeneity argument is valid. It's a very good argument when it applies to things that are actually about people, such as education (which is why I've used that as an example of a much better area to concentrate on eliminating federal interference) or other services that are directly about people.

That doesn't apply to food and drugs however. Food and drugs aren't people. A potato does not have a different shelf life because it's grown in Montana as opposed to Georgia; if it does it's because it's a different variety of potato and if you transplanted the plants to each other's locations you'd suddenly get the opposite type in each place. The Levothyroxin I take here in Texas is the same pill I took in Ohio and it does not need a different, "Texan" regulation because by God, this here's Texas and we don't 'llow no Yankee thyroid pills 'round here.

As for the idea that state run systems would end up being substantially similar in the long run, that's a possibility. However, it largely illustrates the silliness of switching to state-oriented regulations in the first place; if they're all going to be substantially the same, where is the (so far unexplained) possibility for any improvement, in efficiency or otherwise? If homogeneity is bad, then isn't the state-oriented system no better since it will likely be just as homogenous? Why go to the trouble of switching at all since in the long run it won't be all that different?

As to Coro's argument, it was dismissed out of hand because it was based on the silly notion that just because some states are similar in the size of their economy to European nations, that somehow that means they can exercise the same level of autonomy.

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"Hysterical children shrieking about right-wing anything need to go sit in the corner and be quiet while the adults are talking."

To play the devil’s advocated. The only benefit I could foresee by having a state side regulation is on the degree of benefit vs risk on individual risks, which atm is regulated federally.

e.g. pseudoephedrine could be considered over the counter in one state, but requires prescription in another due to the risk of having it being made into illegal drugs.

e.g. the drug Avastin could be approved for cancer treatment across the board in one state, but only be approved for certain cancers in another state.

In Missouri, different counties have laws like that - sudafed requires a script here in St. Charles County, but I can drive 10 minutes east into St. Louis County and get it without one.

Life doesn't come to a screeching halt because of that.

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In time, this too shall pass.

I don't know if canning the FDA completely, especially without a viable replacement is the answer.

However
1. Ron's a doctor so he prolly knows more about the subject than in do.
2. My cousin is convinced the research he is working with can cure leukemia, however he's spent the last decade (not to mention lots and lots of people's money) trying to get it to the point where the FDA will let him test it on humans, and that don't seem right to me. I'm sure there's people out there who would say "I'm dying anyway, let me try it. The worse that could happen is I still die and maybe you'll learn something in the process.

I'm a no sacred cows kind of guy when it comes to government spending, but I don't think we need to chop off whole branches for the sole sake of having a smaller tree when we just need to do some aggressive pruning.

I want a leaner, healthier, more efficient tree rather than a smaller one.

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I prefer to think of them as "Fighting evil in another dimension"

Currently this is achieved by reviewing the drug on a higher level (prescription), which individual locations can then down grade.

The difference in submitting a prescription drug vs OTC drug (on an already established drug) is about 20+ folders of data and about a year of approval time. The difference on a new drug between prescription and OTC is about 80+ folders and 18 month approval time.

If the different states had their own approval process, certain states could have drugs sooner and cheaper.

Keep in mind currently your government pays for the review, which takes a lot of man hours. A new prescription drug submission, if done right, is easily couple of pallets of folders worth of information, on the tax payer's dime.

Before electronic signature were approved by the FDA an average submittal of paperwork was two to four tractor trailers full of folders which had to have backups which had to have backups.

Imagine all the work necessary to do this now understand there is the same amount of work required which means the same delays and costs except it is stored electronically.

Insanity.

The negatives of a bad drug versus the upside of receiving needed treatment when one needs it are things no one gets to weigh but the person themselves or their loved ones if the person is unable to make the decision. No government knows you or your life near enough to decide which option is most likely to fit your personal view of your own future happiness.

The idea that someone else gets to make that decision for you is insane.

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"...but there exists also in the human heart a depraved taste for equality, which impels the weak to attempt to lower the powerful to their own level and reduces men to prefer equality in slavery to inequality with freedom." - De Tocqueville

And then there is this winner of the FDA:

http://articles.businessinsider.com/201 ... ill-bp-oil

Approving for consumption contamination levels of up to 10,000 times those listed as safe.

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"...but there exists also in the human heart a depraved taste for equality, which impels the weak to attempt to lower the powerful to their own level and reduces men to prefer equality in slavery to inequality with freedom." - De Tocqueville