Less government regulation in action

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bravo said:
We have to deal with jerks and dopes that don't know what the hell their talking about and give different answers to the identical questions...
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Blabo should fit right in, then.

How come a conservative wants to get government handouts, anyway?

Poor Blabo.
 
why can't civil asset forfeiture laws be used for situations such as these? If a private individual uses their property for criminal actions, that property gets seized. If a corporation uses it's property for criminal action, why can't it be seized?
 
SmarterthanYou said:
why can't civil asset forfeiture laws be used for situations such as these? If a private individual uses their property for criminal actions, that property gets seized. If a corporation uses it's property for criminal action, why can't it be seized?
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Good questions. Corporations are people, aren't they?
 
An estimated 13,000 patients may have been exposed to the tainted spinal steroid injections which have sickened more than 100 people with fungal meningitis and killed eight, federal officials said Monday, as clinics and surgery centers continued to reach out to those who could be affected.


It was the first estimate of the potential scope of the meningitis outbreak, which has been traced by federal and state investigators to three lots of methylprednisolone acetate injections produced by New England Compounding Center.


Some 105 people in nine states have been sickened by fungal meningitis, said Curtis Allen, a spokesman for the Centers for Disease Control and Prevention.



The outbreak has drawn renewed attention to the little-regulated world of compounding pharmacies.


The FDA is hampered by federal law and conflicting federal court decisions over its authority to regulate compounding pharmacies.


Current and former senior FDA officials said the agency has sought greater authority over the past decade, but so far has been stymied.



Government officials say the FDA is especially concerned about large compounding pharmacies that send out large amounts of drugs across the country—as opposed to a small pharmacy that may compound a medication three or four times a year.



In particular, the agency hasn't been able to take the normal steps it would take to ensure the safety of a drug produced at a compounding pharmacy.


That includes requiring and evaluating clinical trials, and inspection of manufacturing facilities.



Attempts in the past by the agency to regulate more strenuously have been challenged in court.




http://online.wsj.com/article/SB10000872396390443982904578044682649925200.html
 
\\((|))// said:
An estimated 13,000 patients may have been exposed to the tainted spinal steroid injections which have sickened more than 100 people with fungal meningitis and killed eight, federal officials said Monday, as clinics and surgery centers continued to reach out to those who could be affected.

So you are having a shit fit over 0.06% of the folks exposed? Really?

It was the first estimate of the potential scope of the meningitis outbreak, which has been traced by federal and state investigators to three lots of methylprednisolone acetate injections produced by New England Compounding Center.


Some 105 people in nine states have been sickened by fungal meningitis, said Curtis Allen, a spokesman for the Centers for Disease Control and Prevention.



The outbreak has drawn renewed attention to the little-regulated world of compounding pharmacies.

Thought you said there was no regulation?


The FDA is hampered by federal law and conflicting federal court decisions over its authority to regulate compounding pharmacies.


Current and former senior FDA officials said the agency has sought greater authority over the past decade, but so far has been stymied.



Government officials say the FDA is especially concerned about large compounding pharmacies that send out large amounts of drugs across the country—as opposed to a small pharmacy that may compound a medication three or four times a year.

Actually, it would be more concerning for folks that only do it three or four times a year because they would probably not be as good at it. For example. Who would you rather cut out your gall bladder? A doctor who has done it 500 times a year or a surgeon who has done it twice? Common sense always helps if you employ it; kinda like abstinence.

In particular, the agency hasn't been able to take the normal steps it would take to ensure the safety of a drug produced at a compounding pharmacy.


That includes requiring and evaluating clinical trials, and inspection of manufacturing facilities.

Clinical trials to prove what? That the drug actually works? Most compounding done is for off label uses. Who is going to fund these clinical trials? Where is your control group going to come from? Inspecting facilities won't stop bad things from happening. FDA inspects foods all the time and we still get tainted food don't we



Attempts in the past by the agency to regulate more strenuously have been challenged in court.


http://online.wsj.com/article/SB10000872396390443982904578044682649925200.html
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As always, you post a thread claiming to not take a stance while taking a stance. You are an idiot, but on this topic you are woefully out of your league. It is best for you to stop while you are behind.
 
TheJanitor said:
It is not due to lack of funding. However, in the real world of limited resources and opportunity costs, financing is a legitimate issue.

I cited the passage that highlighted the problem. The regulatory authority is unclear.

You are making assumptions and they contradict the stated facts of this story.
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if funding for oversight is not available, then we should put up with dangerous drugs?
 
FactsRStubborn said:
As always, you post a thread claiming to not take a stance while taking a stance. You are an idiot, but on this topic you are woefully out of your league. It is best for you to stop while you are behind.
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So I've posted something inaccurate?

Be specific.
 
Don Quixote said:
if funding for oversight is not available, then we should put up with dangerous drugs?
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How do you propose doing randomized controlled clinical trials on compounded agents of this type?

My guess is that of this pharmacy is indeed responsible, the free market will handle it quite well.

1) if they are found to be negligent they will pay in a court of law and maybe even face criminal charges if possible

2) think anyone will even go to that pharmacy to buy OTC acetaminophen let alone get something compounded?

3) innovative pharmacies will find ways to fill the void and provide the service as more scrutiny will be paid by the public


Let the free market work and it will provide a way.
 
TheJanitor said:
Apparently, you don't know what would happen.

Your wife might not need compounding if not for the milk sugar, but someone else might.

The state of Massachusetts, obviously, has some sort of regulatory authority over this lab. I am sure California does not approve the result of every compounded medication. To do so would be harmful to those in need of compounded medications.
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it regulates compounding pharmacies, but not each compounded prescription, unless a compounded prescription is mass marketed
 
Don Quixote said:
if funding for oversight is not available, then we should put up with dangerous drugs?
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No. You really don't think anything through, do you?

Again, the problem here is not a lack of funding but uncertainty over the regulatory authority of the FDA. It would not cost the FDA much to simply prohibit interstate sell of compounded drugs.

Getting FDA approval for a drug is a huge expense for the manufacturer. Doing so every time a lab compounded a drug would make it impossible for your wife and others to get the medications they need.

Certainly, there needs to be some sort of regulation of the labs, but that is NOT just an issue of funding.

We put up with dangerous drugs, because they are inherently dangerous. There is no amount of money or regulation that is going to change that.
 
TheJanitor said:
No. You really don't think anything through, do you?

Again, the problem here is not a lack of funding but uncertainty over the regulatory authority of the FDA. It would not cost the FDA much to simply prohibit interstate sell of compounded drugs.

Getting FDA approval for a drug is a huge expense for the manufacturer. Doing so every time a lab compounded a drug would make it impossible for your wife and others to get the medications they need.

Certainly, there needs to be some sort of regulation of the labs, but that is NOT just an issue of funding.

We put up with dangerous drugs, because they are inherently dangerous. There is no amount of money or regulation that is going to change that.
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all drugs are compounded

whether by a pharmacist or a drug manufacturer

it is when a compounding pharmacist starts mass making of a drug that they cross the line

the fda should have gotten off of its tail and either inspected the drug manufacturing facilities or forbidden the interstate sale of the drug
 
Don Quixote said:
all drugs are compounded whether by a pharmacist or a drug manufacturer it is when a compounding pharmacist starts mass making of a drug that they cross the line
the fda should have gotten off of its tail and either inspected the drug manufacturing facilities or forbidden the interstate sale of the drug
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Don't conservatives think less government regulation is a good thing?
 
\\((|))// said:
Don't conservatives think less government regulation is a good thing?
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Yes, but we never claimed that having less regulation would prevent bad things from happening. Unless of course you are claiming that having all of the regulations in the world would prevent bad things from happening to people. Is that what you are claiming.

You see my little idiot, life is full of tradeoffs. Drugs manufactured by large pharmaceutical companies are done in very large batches and sort of a one size fits all. Some folks (and it sounds like DQs wife is one of them) is unable to take those medications. So what is the alternative to alleviate her suffering? Should we force the large pharma companies to manufacture lots suitable to EVERY single person? Well, that wouldn't be very efficient and would increase costs dramatically.

Or do we allow individual pharmacies to compound these one off items to suit the needs of a patient. Now if you expose these pharmacies to randomized controlled clinical trials then you would effectively shut them down. "Oh you would shriek, we aren't trying to shut them down, we just want them to be safe". Sounds good doesn't it? Sorta like you don't want to ban the incandescent lightbulb while making it harder and harder to produce them. But, I digress. The reason they would stop doing it is because randomized controlled clinical trials are expensive. Very expensive. Who would fund it? The drug companies? They have no financial incentive. You? Your tax dollars? What another board to determine would should be studied? The net result of your "poo gooder" attitude is that DQs wife would suffer needlessly.

Yes, we have way too much regulation. Pointing to anything bad that happens in society and making a faux argument as if it were a result of a lack of regulation is childish at best. Of course maybe you are saying that regulations will prevent any harm from happening to any person ever? Is that what you are saying? That is of course the logical corrollary to what you are saying right? Well, then you don't really say anything do you troll? You just slap up your hit and run posts and hide behind "did I say that?".
 
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