Fda (1 Viewer)

[The Real McCoy]

Can someone explain to me why the FDA shouldn't go the way of the dinosaurs and the dodo? I don't get it. Why must the government have a monopoly on the approval of food and medicines?

Take a look at the bottom of your mouse, or back of your computer, or TV, or stereo, or smoke detector, or most any kitchen appliance. You're likely to find the UL logo. Companies shell extra money out of their pockets to pay for UL testing and certification. They're not forced to, but they do because of ULs reputation. Why can't there be quality assurance companies like this for food and drugs?

FDA testing costs hundreds of millions and can take up to 10 or 15 years before a drug can hit the market. Then they proudly announce a recently approved pill will save 10,000 lives a year. Does this mean 100,000 pointlessly died in the process? Most small pharmaceuticals can't afford FDA testing so we're left with leviathans like GSK, Pfizer, Merck et al. These corporations have much lobbying influence in congress too. This is bad juju.

 

[Kandahar]

Ugh, the FDA is a terrible little organization with a lot of blood on its hands. I absolutely agree that drug certification should be optional. All drugs (including recreational ones) should be completely legal for adults, with the understanding that you are using them at your own risk.

 

[FallingPianos]

Can someone explain to me why the FDA shouldn't go the way of the dinosaurs and the dodo? I don't get it. Why must the government have a monopoly on the approval of food and medicines?

Take a look at the bottom of your mouse, or back of your computer, or TV, or stereo, or smoke detector, or most any kitchen appliance. You're likely to find the UL logo. Companies shell extra money out of their pockets to pay for UL testing and certification. They're not forced to, but they do because of ULs reputation. Why can't there be quality assurance companies like this for food and drugs?

FDA testing costs hundreds of millions and can take up to 10 or 15 years before a drug can hit the market. Then they proudly announce a recently approved pill will save 10,000 lives a year. Does this mean 100,000 pointlessly died in the process? Most small pharmaceuticals can't afford FDA testing so we're left with leviathans like GSK, Pfizer, Merck et al. These corporations have much lobbying influence in congress too. This is bad juju.

I do thing that all drugs should go through some sort of standardised testing, but the medical community should be left with the decision of whether or not the risks of a drug are worth the benefits.

 

[CaptainCourtesy]

Ugh, the FDA is a terrible little organization with a lot of blood on its hands. I absolutely agree that drug certification should be optional. All drugs (including recreational ones) should be completely legal for adults, with the understanding that you are using them at your own risk.

Though I don't agree with some of the things about the FDA (effiency being one), without any drug regulation, quality control goes out the window. People require life-saving or life-sustaining medications will be playing russian roulette, never knowing whether the medication will work or not. And remember, one is paying good money for this medication. It's like buying a car and being told, 'Maybe the car will work, maybe it won't, but you have to pay for it anyway. And if it doesn't, oh well.' Some quality control is essential to prevent unsavory business practices.

 

[Kandahar]

Though I don't agree with some of the things about the FDA (effiency being one), without any drug regulation, quality control goes out the window. People require life-saving or life-sustaining medications will be playing russian roulette, never knowing whether the medication will work or not.

Not true. I like Real McCoy's analogy in his original post: Companies pay for UL certification even though they aren't required to, because of it's reputation. If the FDA didn't certify drugs, some other private organization almost certainly would.

And remember, one is paying good money for this medication. It's like buying a car and being told, 'Maybe the car will work, maybe it won't, but you have to pay for it anyway. And if it doesn't, oh well.' Some quality control is essential to prevent unsavory business practices.

Maybe I didn't explain my position very well. I think that if a company wants to release a drug to the market, they have the responsibility to tell the consumers what the benefits and side effects were when they tested the product.

This is a better system than the FDA for a number of reasons. As long as the company wasn't presenting fraudulent claims, they couldn't be sued (thus reducing the cost of medicine to the consumer). If a consumer felt that the medication was unsafe (say, because it hadn't been certified by a watchdog group) they wouldn't have to buy it. But if they felt that it was worth the risk to improve their condition, they could do so.

One of the problems with the FDA is that it's inherently political. It always errs on the side of caution, because if they certify a drug that turns out to have major problems, it's a major political scandal. But if they hold up drug certification for years, more people will die, but you won't see them on the news.

 

[CaptainCourtesy]

Not true. I like Real McCoy's analogy in his original post: Companies pay for UL certification even though they aren't required to, because of it's reputation. If the FDA didn't certify drugs, some other private organization almost certainly would.

Because your first post seemed somewhat anarchistic, and didn't claim this, I didn't address it. I agree that this would be appropriate if it could be done, but remember, we're not talking about mice or light bulbs here. If one of them is defective, though there are risks, you don't have the same potentially significant risks you could have with medication. I think a private organization in the medication field would be a hard sell.

Maybe I didn't explain my position very well.

Yup. :mrgreen:

I think that if a company wants to release a drug to the market, they have the responsibility to tell the consumers what the benefits and side effects were when they tested the product.

Which, I believe is what they are required to do, currently.

This is a better system than the FDA for a number of reasons. As long as the company wasn't presenting fraudulent claims, they couldn't be sued (thus reducing the cost of medicine to the consumer). If a consumer felt that the medication was unsafe (say, because it hadn't been certified by a watchdog group) they wouldn't have to buy it. But if they felt that it was worth the risk to improve their condition, they could do so.

Again, I would have an issue with the private organization/watchdog group. What is to stop them from selling certifications? Or refusing to sell a certification because another company pays them as that company has a similar medication that they don't want competition? Though, in theory, I think this could work, in practice, it would be very difficuly, especially with how much pharmaceuticals are big business.

One of the problems with the FDA is that it's inherently political. It always errs on the side of caution, because if they certify a drug that turns out to have major problems, it's a major political scandal. But if they hold up drug certification for years, more people will die, but you won't see them on the news.

I agree that the amount of time it takes for a medication to be certified is very long. I think a graduated schedule would work better, something along the lines of what you proposed. Release a medication with the warning that it hasn't been certified by the FDA, yet. Those who take it, take it at their own risk. Once a medication is certified, all things stand as they are. This could actually speed up certification or non-certification of drugs, as their would actually be a larger sample pool in which to examine results.

 

[The Real McCoy]

I agree that this would be appropriate if it could be done, but remember, we're not talking about mice or light bulbs here. If one of them is defective, though there are risks, you don't have the same potentially significant risks you could have with medication.

The FDA approves drugs that turn out to be defective all the time. Contrary to popular belief, government agencies are in fact run by ordinary human beings.

Again, I would have an issue with the private organization/watchdog group. What is to stop them from selling certifications?

Their reputation?

Though, in theory, I think this could work, in practice, it would be very difficuly, especially with how much pharmaceuticals are big business.

With FDA testing costs frequently approach a billion $, Big Pharma are the only players who can afford to stay in the market.

I agree that the amount of time it takes for a medication to be certified is very long. I think a graduated schedule would work better, something along the lines of what you proposed. Release a medication with the warning that it hasn't been certified by the FDA, yet. Those who take it, take it at their own risk. Once a medication is certified, all things stand as they are. This could actually speed up certification or non-certification of drugs, as their would actually be a larger sample pool in which to examine results.

Exactly. Open certification up to private competitors.

 

[CaptainCourtesy]

The FDA approves drugs that turn out to be defective all the time. Contrary to popular belief, government agencies are in fact run by ordinary human beings.

No argument with this point.

Their reputation?

Any regulatory agency that is for profit makes me suspicious. Sure, with the FDA there is the potential for political gain. When high monetary greed is involved, the risks of corruption in an agency that regulates medications seems too high.

With FDA testing costs frequently approach a billion $, Big Pharma are the only players who can afford to stay in the market.

Which is why my thoughts aim towards a tierred certification approach, with medications released with either an FDA conditional (untested or testing in progress) certification, or an FDA unconditional (tested and approved) certification.

Exactly. Open certification up to private competitors.

Nah, revamp the current system. Allowing this to be privatized could lead to 'highest bidder certification' wars with new medications; the problems of 'Big Pharma companies being the only players who can afford to stay in the market' would still exist.

 

[Kandahar]

Any regulatory agency that is for profit makes me suspicious. Sure, with the FDA there is the potential for political gain. When high monetary greed is involved, the risks of corruption in an agency that regulates medications seems too high.

If a private company certified a drug that they knew to be unsafe to earn a few extra dollars, their reputation would decline. If their reputation declined, consumers would no longer care about their certification, and therefore businesses would stop paying for their certification.

Which is why my thoughts aim towards a tierred certification approach, with medications released with either an FDA conditional (untested or testing in progress) certification, or an FDA unconditional (tested and approved) certification.

Maybe I'm not understanding you correctly...since the drugs would be legal with "conditional" certification, what incentive does the company have to jump through the FDA's hoops to get this "unconditional" certification? If the only thing that would do is promote consumer confidence, no one would bother, because they'd just find a private company to certify it more cheaply and more efficiently than the FDA would.

Nah, revamp the current system. Allowing this to be privatized could lead to 'highest bidder certification' wars with new medications

That hasn't happened for any other industry where private certification is commonplace. Why would pharm be any different?

 

[CaptainCourtesy]

If a private company certified a drug that they knew to be unsafe to earn a few extra dollars, their reputation would decline. If their reputation declined, consumers would no longer care about their certification, and therefore businesses would stop paying for their certification.

True. My concern is without regulation of these private companies, how would one really know that they are non-corrupt. In order to increase confidence, some overseeing agency would need to watchdog this sector. It could be kinda like politics; we often don't vote for who we want, we vote for who we think will do the least amount of damage.

Maybe I'm not understanding you correctly...since the drugs would be legal with "conditional" certification, what incentive does the company have to jump through the FDA's hoops to get this "unconditional" certification? If the only thing that would do is promote consumer confidence, no one would bother, because they'd just find a private company to certify it more cheaply and more efficiently than the FDA would.

I disagree. Consumer confidence would absolutely enhance sales; the certification would be a boon to profits. Most would prefer to purchase something 'certified' safe, rather than 'might be' safe.

That hasn't happened for any other industry where private certification is commonplace. Why would pharm be any different?

Good question. Just speculation on my part; being that pharmaceuticals are such big business. It's late, and I'll try to research how this occurs in other industries, later.

 

[Kandahar]

True. My concern is without regulation of these private companies, how would one really know that they are non-corrupt. In order to increase confidence, some overseeing agency would need to watchdog this sector. It could be kinda like politics; we often don't vote for who we want, we vote for who we think will do the least amount of damage.

Well, presumably there would be more than one company in the certification business, and therefore they'd oversee each other. If it became clear that one company was making a lot of mistakes, the other companies would capitalize on it and make sure everyone knew that THEIR certification was more reliable.

I disagree. Consumer confidence would absolutely enhance sales; the certification would be a boon to profits. Most would prefer to purchase something 'certified' safe, rather than 'might be' safe.

My point is that there's no reason consumers would feel safer with a product certified by the FDA, versus a product certified by a reputable private company. Certainly the marginal effect wouldn't be enough for the company to justify hundreds of millions of extra dollars per drug in government red tape.