When is the FDA going to mind their own business?

[Thump553]

Originally posted by: microbial
The FDA is not immune from the phenomena of political policy and lobbying trumping science. Not the least in the last 8 years.

Having said that--would anyone really argue to allow the drug industry and the food industry to self-regulate themselves?

Not me.

Seems to me, a more sensible alternative would be to populate the agency with more professional scientists and less administrivial hacks, and insulate the agency from political pressure. Same goes for a number of other agencies.

Private industry might not be too thrilled with that kind of change.

At last, someone who has a rational answer.

 

[Bitek]

Originally posted by: Thump553

Originally posted by: microbial
The FDA is not immune from the phenomena of political policy and lobbying trumping science. Not the least in the last 8 years.

Having said that--would anyone really argue to allow the drug industry and the food industry to self-regulate themselves?

Not me.

Seems to me, a more sensible alternative would be to populate the agency with more professional scientists and less administrivial hacks, and insulate the agency from political pressure. Same goes for a number of other agencies.

Private industry might not be too thrilled with that kind of change.

At last, someone who has a rational answer.

The FDA is populated with highly knowledgeable and professional people. Only the very top are appointees and political people, and I don't think its nec fair to assume they are all Micheal Brownies. The people on the ground, the regulators and inspectors are well educated and professional people. And I can tell you, Pharmas are scared shitless of them.
(A number are ex-FBI at that, and know how to find things you may try to hide.)

FDA has the right to come into your facility at anytime for any reason unannounced, and demand to see your manufacturing records, SOPs, manufacturing deviation records, customer complaints (manu's required to keep,) training files, as well as observe any process they want for as long as they want. And these inspectors do, and often.

If they don't like what they see, they can and will cite you and require you to make the necc process changes. These citations become public record. Sanctions can run from simple change requirements to fines to revoking/suspending sales licenses to even prison terms (in a very very extreme case.) They are a big fucking deal. Want to read about the program? Here's a recent search of Warning Letters. A mid-level citation as far as things go. Search FDA 483 for more severe observations. A consent decree is a double anal fist fuck you do not want to happen, that will cost you millions of $$, big market share, years on your competitors, frequent and hostile FDA visits, and can destroy your company if you aren't too big to weather it.

Different products have different standards. Pharmaceuticals are the most tightly regulated, and least tolerant to errors. Medical devices are lower, and food is much lower than that. Things like herbs and supplements are not regulated at all. (things like hydroxycut and herbs like echinacea fall into the later.)


If, IF, by some means you managed to "corrupt" a FDA inspector or even agency, Pharmas are still regulated by any regulatory agency in which they sell products. For big things like drugs or med devices, this could mean every country in the world. Canadian have their own agencies that will do inspections (can't just roll up on you on US soil like FDA can, but can shut you out of their country if you refuse) as do the EU, Japan, Brazil and SA. ISO audits.. Customers do their own audits, such as the Red Cross and or any company you supply raw materials to (and they are required by FDA et al.) FDA is the most aggressive, but all can F you up if you are doing something non-compliant (and get the FDA on your ass.)

Now a non regulated product like supplements can be grinding up rats and selling it as a magic dick potion, and its not under FDA's jurisdiction. OTOH, if I'm working in a drug manuf lab, and I have an SOP that says I have to open the lab door with my left hand, and I open it w/ my right, the FDA can cite you if they catch you. And the level of control they want you to have over your process goes nearly down to that level. Seriously. For everything.

Everything you needs to be described in a written SOP, training files for those doing it, a validation report showing it works, a monitoring program to see that its properly done that way, a calibration program if there's a spec or measurement involved, a traceablity procedure to document everytime it was done, and a change control program to govern any proposals to do it a different way and that it addresses all the aforementioned requirements.

Now, its a perfectly reasonable debate to whether the way the FDA regulates is the most effective or not. Casually throwing around accusations of corruption or conspiracy is just plain ignorant.

Working in the industry, I'm glad the FDA regs are there. They are a blunt instrument, not always fair or the most effective, but it does create a foundation of standards to follow. People get busy, tired, lazy or sometimes don't think everything thru. Some people just don't give a shit. You need this framework to ensure people are motivated to do things properly and safe or some people will take shortcuts and endanger a large number of people. FDA or no, some people do stupid things anyway.

Just look at the shit going on in China for an example of what happens when people are left to their own devices. They can do things cheaper and faster in some ways, but OTOH, but in the US you don't have to worry that your toothpaste is going to poison you, formula will kill your baby, drugs have a good chance to kill you if they work at all, and lab tests actually provide the data and results they are supposed to and doctors can make good decisions based on them.

 

[bamacre]

Originally posted by: Moonbeam

Originally posted by: Vic

Originally posted by: Moonbeam
Are you your brother's keeper?

Yes, from yourself. Not from himself without his consent.

So if I can pull him down from the bridge he wants to jump from, I should not?

What Vic is saying is that this is up to you, if you want to use your resources to feed the homeless, do it, that is your right. But you shouldn't be able to take my resources without my consent in order to do it.

 

[Moonbeam]

Originally posted by: bamacre

Originally posted by: Moonbeam

Originally posted by: Vic

Originally posted by: Moonbeam
Are you your brother's keeper?

Yes, from yourself. Not from himself without his consent.

So if I can pull him down from the bridge he wants to jump from, I should not?

What Vic is saying is that this is up to you, if you want to use your resources to feed the homeless, do it, that is your right. But you shouldn't be able to take my resources without my consent in order to do it.

I think you are right that that is what he meant and I misunderstood him.

But if so, surely we tax him to raise an army to defend us even though he may not want to be defended, no?

And we have means by which we can deem people incompetent to manage their own affairs, so even so I don't see how any of this is black and white. In all of it, it seems to me, that judgment is required, and what people think is judgment, good or bad, is what is at issue.

 

[Moonbeam]

Originally posted by: BoberFett

Originally posted by: Moonbeam

Originally posted by: Vic

Originally posted by: Moonbeam
Are you your brother's keeper?

Yes, from yourself. Not from himself without his consent.

So if I can pull him down from the bridge he wants to jump from, I should not?

Is truth just all subjective or can one person know and understand far far more than some other and what actions if any, may real knowledge oblige?

What is the force that drives a person who has no self?

When Moonie is out of answers, he turns to psychobabble bullshit.

You are not your brother's keeper. Any philosophical issues that might pertain to that subject could not have any applicability to you. You left the discussion. Please excuse, therefore, my out of hand dismissal of your philippic as desultory and without any application or relevance.

 

[bamacre]

Originally posted by: Moonbeam

Originally posted by: bamacre

Originally posted by: Moonbeam

Originally posted by: Vic

Originally posted by: Moonbeam
Are you your brother's keeper?

Yes, from yourself. Not from himself without his consent.

So if I can pull him down from the bridge he wants to jump from, I should not?

What Vic is saying is that this is up to you, if you want to use your resources to feed the homeless, do it, that is your right. But you shouldn't be able to take my resources without my consent in order to do it.

I think you are right that that is what he meant and I misunderstood him.

But if so, surely we tax him to raise an army to defend us even though he may not want to be defended, no?

Perhaps, but let us not forget that federal government receives large amounts of revenue via means other than personal income taxes. So the question becomes, defend us from who? I'm sure you will agree our department of defense has become a department of offense, and why not? They have the money, or rather, they can get it from you. With the power to print and to tax your income, they have a bottomless pit of our resources to take and spend. But here we are speaking of defense from outside forces rather than defense from our own selves, which is the topic of discussion.

And we have means by which we can deem people incompetent to manage their own affairs, so even so I don't see how any of this is black and white. In all of it, it seems to me, that judgment is required, and what people think is judgment, good or bad, is what is at issue.

Who gets to decide who is incompetent? Are we to be a society that protect peoples' rights and property, or a thieving tyranny? I think history has shown that our misguided belief that we can have our cake and eat it too always leads to the later.

 

[Vic]

Originally posted by: Moonbeam
I think you are right that that is what he meant and I misunderstood him.

What I meant is that you are not being your brother's keeper when you keep him against his will. That is just another way of selfishly inflicting harm.

 

[Moonbeam]

Originally posted by: Vic

Originally posted by: Moonbeam
I think you are right that that is what he meant and I misunderstood him.

What I meant is that you are not being your brother's keeper when you keep him against his will. That is just another way of selfishly inflicting harm.

Well then we are back to my questions. Can one person have such poor judgment as to be a danger to himself and can and should those with better judgment intervene. Our laws seem to say we can and should. I don't think, for example, you can be drunk in public even if you don't harm anyone.

 

[Vic]

Originally posted by: Moonbeam

Originally posted by: Vic

Originally posted by: Moonbeam
I think you are right that that is what he meant and I misunderstood him.

What I meant is that you are not being your brother's keeper when you keep him against his will. That is just another way of selfishly inflicting harm.

Well then we are back to my questions. Can one person have such poor judgment as to be a danger to himself and can and should those with better judgment intervene. Our laws seem to say we can and should. I don't think, for example, you can be drunk in public even if you don't harm anyone.

Do those of better judgment intervene out of some genuine sense of altruism to help those of poor judgment, or because they want to reinforce the notion that they have better judgment?

And public drunkenness isn't illegal because people are concerned the drunks might harm themselves.

 

[BoomerD]

And here's yet another story of the busybodies in government trying to interfere with a business trying to make a profit:

http://www.news10.net/news/loc...ory.aspx?storyid=58756

SACRAMENTO, CA - The California Department of Public Health warned consumers Saturday against eating a lollipop product imported from Mexico after tests found unacceptably high levels of lead.

Recent analysis of the Hola Pop La Original Lollipop Candy, manufactured by Productos Hola Del Noroeste S.A. de D.V. in Mexico, determined the candy contained as much as 0.25 parts per million of lead, CDPH director Dr. Mark Horton said. California considers candies with lead levels in excess of 0.10 ppm to be contaminated.

Horton said the CDPH was working with distributors to ensure that the contaminated candies were removed from store shelves.

Hola Pop La Original Lollipop Candy is sold in two different package styles. One package is a round clear plastic container with a bright yellow lid that contains 36 individually-packaged lollipops. The second type of packaging is a 'strip' of 10 individually packaged lollipops. Both package types contain tamarind, orange, strawberry and pineapple flavors.

Consumers who find Hola Pop La Original Lollipop Candy for sale were encouraged to call the CDPH Complaint Hotline at 1-800-495-3232.



It's certainly none of the government's business if a Mexican candy company wants to sell it's lead-tainted lollipops to kids.

Let the kids decide whether they want to eat the stuff or not. Besides, after a few, they'll be too brain-damaged to even know...

The government should just keep its nose out of other people's business...:roll: