The FDA does not regulate herbs and dietary supplements- other than to restrict those which are found to be harmful to people. Unlike drugs, dietary supplements do not even have to contain the substances they claim to.
Taxes or borrowing. That is how the FDA is funded. I am not arguing for a free market replacement for it although some here are. You need an organization with the power to punish all who do not follow safety rules. A "merchant organization" with voluntary participation could only impose rules on members and would have to rely on them for funding. If they do have the power over non- members, why pay the money to join and could they decide to punish non- members more heavily than members? Most companies only recall products when they are forced to- not voluntarily. Especially things like medicines and drugs which cost a lot of money to develop and also have large dollar returns for the manufacturer once they get to market.
Me too, but please answer the following questions:Well I personally like the fact that there is an agenecy out there which makes sure that medicines are safe and effective and contain what they are supposed to and that harmful things like contaminated foods are kept out of the food supply.
Well I personally like the fact that there is an agenecy out there which makes sure that medicines are safe and effective and contain what they are supposed to and that harmful things like contaminated foods are kept out of the food supply. I see much good from the FDA which to me outweighs the negatives you see. But that is your opinion and mine. I do not think it would be a better idea to have a voluntary organization comprised of food manufacturers and drug companies trying to regulate the same thigns. I would have much less faith in them. I think that what scares some people is the idea that it is a government agency and some people feel that anything governemnt is evil. There are also those who disagree with any sort of restrictions on anything at all and want to do whatever they want to whenever they want with no consequences for themselves.
Well I personally like the fact that there is an agenecy out there which makes sure that medicines are safe and effective and contain what they are supposed to and that harmful things like contaminated foods are kept out of the food supply.
I see much good from the FDA which to me outweighs the negatives you see.
I think that what scares some people is the idea that it is a government agency and some people feel that anything governemnt is evil.
There are also those who disagree with any sort of restrictions on anything at all and want to do whatever they want to whenever they want with no consequences for themselves.
I've used the UL example before- .....................................................................................................................
Much better than the one-size-fits-all. A good example of how this helps for the FDA is that some very sick patients can not get some trial medications since they haven't been blessed by the FDA yet, but the patients are more than willing to give it a shot so they end up having to go overseas....................................................................................................................................................................................................................................................
It's interesting to note that UL lists in their FAQ that they aren't a part of any government. I'd guess maybe people just think that they are.
http://www.ul.com/faq/facts.html
... Hundreds of thousands of deaths occur every year from just taking prescription drugs as prescribed...
How would that work for the recall of harmful procucts? Is a group which is funded by member companies going to be willing to say that one company has to stop making something or will they be more willing to allow it to continue to be made and distributed? You would have the fox guarding the hen house.
I know I posted words to this effect a long time ago, but I used to work in the medical devices industry (very much like big pharma, we made items that big pharma used and also tons of the devices that doctors and hospitals use. Everything from syringes, to veterinary diagnostic mediums.
I was audited twice by the FDA, once for my environmental lab and once on a large project that I'd completed. My conclusion? These guys are BUFFOONS who have a "cop with a quota" mentality that ends up costing both the company and the consumer.
Want to know why many of your medical bills are so outrageous? When I was in the enviro lab (I tested and refined clean rooms for acceptable levels of cleanliness in the manufacturing/production areas. So, I had to base all my standard operating procedures on the Code of Federal Regulations (CFR), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), specifically 21 CFR part 820. (I still have nightmares about 21 CFR part 11.)
Most of these documents are so vague that you can have as many interpretations of them as you can of the bible. I wrote my SOP's precisely and made sure they covered everything in the CFR and then some. Not only did the agents not really understand the purpose, they didn't understand the statistics. I ended up having to re-write all the SOP's to be less effective for our purposes, at the whim of the agent. I bitched, I argued (to my boss, because you aren't allowed to argue with an agent, we were coached prior to the FDA inspection to answer only a specific question and say no more or no less--sound familiar?) And with good reason, they are looking to find something, anything, even if it has nothing to do with the quality or efficacy of the end product. I spent an entire week putting bullshit practices in to place and implementing a procedure that did absolutely nothing to reassure that the product was safe.
Of course, after the audit was completely over, I spent another several days re-writing the SOP's (again) and scientifically and statistically showing why the new procedure was BS--but I couldn't do that until the inspection was over and I had officially re-written the procedures recommended.
How's that for a waste of time and money? If the FDA were reasonable or rational I might cut them some slack. But it's apparent to me that they look the other way with the big players in Pharma, but overall increase the cost and the BS red tape where it isn't necessary.
So, yeah, I'm a huge fan of getting rid of the FDA and replacing it with an independent quality organization or a complete sensible revamp.
.......
I think the incidence of sick patients not being able to get drugs that haven't been approved by the FDA are few and far between. A far WORSE problem is that the FDA approves far too many drugs too soon. Hundreds of thousands of deaths occur every year from just taking prescription drugs as prescribed. This is because the testing of the drugs done before hand is paid for by the companies who want to market them and obviously the results, since the tests are not independently done, are going to show that the drugs are "safe" so the FDA will approve them.
People have to begin to realize that the FDA is an organization designed to support the food and drug industry ----not protect consumers.
I know I posted words to this effect a long time ago, but I used to work in the medical devices industry (very much like big pharma, we made items that big pharma used and also tons of the devices that doctors and hospitals use. Everything from syringes, to veterinary diagnostic mediums.
I was audited twice by the FDA, once for my environmental lab and once on a large project that I'd completed. My conclusion? These guys are BUFFOONS who have a "cop with a quota" mentality that ends up costing both the company and the consumer.
Want to know why many of your medical bills are so outrageous? When I was in the enviro lab (I tested and refined clean rooms for acceptable levels of cleanliness in the manufacturing/production areas. So, I had to base all my standard operating procedures on the Code of Federal Regulations (CFR), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), specifically 21 CFR part 820. (I still have nightmares about 21 CFR part 11.)
Most of these documents are so vague that you can have as many interpretations of them as you can of the bible. I wrote my SOP's precisely and made sure they covered everything in the CFR and then some. Not only did the agents not really understand the purpose, they didn't understand the statistics. I ended up having to re-write all the SOP's to be less effective for our purposes, at the whim of the agent. I bitched, I argued (to my boss, because you aren't allowed to argue with an agent, we were coached prior to the FDA inspection to answer only a specific question and say no more or no less--sound familiar?) And with good reason, they are looking to find something, anything, even if it has nothing to do with the quality or efficacy of the end product. I spent an entire week putting bullshit practices in to place and implementing a procedure that did absolutely nothing to reassure that the product was safe.
Of course, after the audit was completely over, I spent another several days re-writing the SOP's (again) and scientifically and statistically showing why the new procedure was BS--but I couldn't do that until the inspection was over and I had officially re-written the procedures recommended.
How's that for a waste of time and money? If the FDA were reasonable or rational I might cut them some slack. But it's apparent to me that they look the other way with the big players in Pharma, but overall increase the cost and the BS red tape where it isn't necessary.
So, yeah, I'm a huge fan of getting rid of the FDA and replacing it with an independent quality organization or a complete sensible revamp.
Pay attention to this post. It was spot on and describes every regulatory industry in this country.
I'm a chemist, and Department of Homeland Security is now trying to monitor what solvents every lab in my building is using. I can no longer go to a general stock room to fill up on my solvents and I must place the order for my specific lab in order to obtain a certain solvent. They are trying to monitor specific chemicals because a lot of them can be used to make bombs. These regulations are nothing but a pain in the ass that gets in the way of my daily activities because it causes nothing but delays. Furthermore, my coworkers and I already devised a system to circumvent their monitoring in under a week. You, the taxpayer are paying billions of dollars for an organization that will fail miserably. They are powerless to limit the chemicals I obtain and they are powerless to monitor what I do with them. Now, the reality is, I only need certain chemicals to wash glassware. So, there's no harm in me obtaining those chemicals. Yet, a large portion of America now feels like they are much safer because there is someone looking over my shoulder.
Regardless, these types of policies are beyond ridiculous because any chemist can go to home depot and make a bomb. You don't see Department of Homeland Security monitoring their store (and I'm not suggesting they should). It's just all pointless and the sooner people realize these false safety nets provide no safety at all, the better off they would be.