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Sen. Paul Offers Amendment to Rein in FDA Abuses
Rand Paul ^ | May 23, 2012 | Rand Paul

Posted on 05/28/2012 3:18:06 AM PDT by yoe

Today on the U.S. Senate floor, Sen. Rand Paul introduced an amendment to the Food and Drug Administration User Fee Reauthorization bill, which would curb the Food and Drug Associations overreach and abuse of power. Sen. Paul's amendment, No. 2143, would disarm the FDA, put an end to raids on natural food stores and Amish farmers, and stop FDA censorship of truthful claims of dietary supplements.

[snip] "Mr.President, today I'm offering an amendment to the FDA. I'm troubled by images of armed agents raiding Amish farms and preventing them selling milk directly from the cow. I think we have bigger problems in our country than sending armed FDA agents into peaceful farmers' land and telling them they can't sell milk directly from the cow.

My amendment has three parts. First, it attempts to stop the FDA's overzealous regulations of vitamins, food and supplements by codifying the first amendment prohibition on prior restraint. What do I mean by that?

(Excerpt) Read more at paul.senate.gov ...


TOPICS: Constitution/Conservatism; Government
KEYWORDS:

1 posted on 05/28/2012 3:18:11 AM PDT by yoe
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To: yoe

Now that’s a breath of fresh air!


2 posted on 05/28/2012 3:21:03 AM PDT by ransacked
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To: ransacked

Disarming the FDA only received 15 votes.


3 posted on 05/28/2012 3:39:14 AM PDT by abercrombie_guy_38
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To: ransacked; yoe

” Now that’s a breath of fresh air! “

It’s a step in the right direction, but it’s a retail approach to a problem that needs wholesale solutions —

All Federal Agencies should be abolished, and then the ones with true ‘necessary and proper’ (and Constitutional) functions can be re-established with strict limits to their power, and controls with oversight - and mission statements clearly written to preclude ‘mission creep’...


4 posted on 05/28/2012 3:43:33 AM PDT by Uncle Ike (Rope is cheap, and there are lots of trees...)
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To: yoe

Could he do that to the EPA too?


5 posted on 05/28/2012 4:00:03 AM PDT by freekitty (Give me back my conservative vote; then find me a real conservative to vote for)
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To: yoe

What is needed is a SIMPLE way to report bad drug side effects. As a person who has had to many brushes with the side effect riddled crap, trying to report it is near impossible. And don’t rely on your doctor to do it, they don’t even read your health history, much less your drug reaction list.

Why are drugs with a 50% side effect failure rate allowed to be manufactured? That is an F in any one’s book!


6 posted on 05/28/2012 4:21:11 AM PDT by GailA (Any congress critter or president who FAILS to keep faith with the Military, WON'T keep faith with U)
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To: yoe

Ugh, this one needs to go down in flames. I would hate to go back to the days where anyone could sell anything, caveat emptor, and injured people had no recourse. No safety standards for food products... no safety and efficacy testing of drugs... snake oil salesmen being able to make any scientifically baseless claim about their wares, while selling bottles of poison... NO, THANKS!

The Constitution mandates that the Federal government provide for the general welfare of its citizens. The FDA is a large part of that effort. There are plenty of federal agencies that don’t meet any Constitutional requirement—why doesn’t Rand Paul go after them?


7 posted on 05/28/2012 4:34:15 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: GailA
What is needed is a SIMPLE way to report bad drug side effects. As a person who has had to many brushes with the side effect riddled crap, trying to report it is near impossible. And don’t rely on your doctor to do it, they don’t even read your health history, much less your drug reaction list.

Why are drugs with a 50% side effect failure rate allowed to be manufactured? That is an F in any one’s book!

All drugs have side effects. It sounds like you're one of the unlucky people who has a particular genetic makeup that causes you to be particularly susceptible to side effects. In any case, you can report drug side effects here. There are links to forms right on the website.

8 posted on 05/28/2012 4:39:02 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: exDemMom

Nightmare to try to do so, have tried it. Yes I am that 2-5% who react badly to most of the newer drugs.

And I can’t get my doctors to stop prescribing the stupid things. So I just send them back to the pharmacist marked ALLERGIC, and cancel prescription! And add to my VERY long list of drug reactions.

Last one was Zetia...it was written off a cholesterol report taken during a Vertigo and Meniere’s attack when food and water tasted like cardboard....It hits all 4 of my auto immunes for just it’s common side effects. I don’t like spending hours hugging the toilet puking my guts up because of 1 pill or having my pain level go from 3 to puke level in less than an hour. And yes I can react that fast to some of them. Others takes weeks.

They are all supposed to be ‘flagged’ in my pharmacist computer, some how it never works. Good thing I pick up our meds, and not my husband, because he’d bring the dang things home, where I won’t.


9 posted on 05/28/2012 5:15:22 AM PDT by GailA (Any congress critter or president who FAILS to keep faith with the Military, WON'T keep faith with U)
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To: exDemMom

As I read the bill, it strengthens the need to prove willful and knowing intent to cause harm AND it disarms the agency. It allows an oat cereal to state that studies show oat fiber can reduce cholesterol or that prune juice can be laxative. That is not wholesale allowing of snake oil. Oat fiber or prune juice will not kill or even injure you and if you want to drink raw milk, that is not the purview of government. Yes, the individual drinking the milk _could_ become ill, but they aren’t going to cause an epidemic. Millions of us have ingested clean milk direct from a bulk tank or from a cow and lived to tell the tale. I am one of those.

And, as I understand it, it did not pass.

OTOH, the fine print on many drugs is difficult to read and requires a medical dictionary to decipher. Drugs, devices and treatments are regularly passed by the FDA that later turn out to have debilitating and life threatening side effects. Recourse is expensive and class actions only benefit the attorneys. There is no real protection because of FDA.

Normal food production and processing inspections miss many instances where numbers of individuals are sickened, permanently harmed or killed by pathogens. These are failures of the food inspection process that are not addressed in this bill.

A government bureaucracy is not eliminating threats by regulating around the edges of the problem. They appear to go after relatively innocent practices while not being able to address the serious problems.


10 posted on 05/28/2012 5:46:07 AM PDT by reformedliberal
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To: GailA
And I can’t get my doctors to stop prescribing the stupid things. So I just send them back to the pharmacist marked ALLERGIC, and cancel prescription! And add to my VERY long list of drug reactions.

I have found that if I speak up quickly, I can get the MD to prescribe a different drug. If you know what does work, that helps the MD to make better prescription decisions. I had to go to the emergency room last year; I told every single person that saw me that I did NOT want narcotics, and no one tried to give me any.

11 posted on 05/28/2012 5:54:17 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: exDemMom

If your interpretation of the “general welfare” clause is correct then there are no constitutional limits on what the federal government can do.


12 posted on 05/28/2012 6:10:38 AM PDT by Valentine Michael Smith (You won't find justice in a Courtroom)
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To: exDemMom

You don’t have my non-listening internist..and as we are both Medicare and Tricare Life, it is extremely hard to find doctors to take us as new patients. Or I would have changed doctors 3 years ago. He listens to my husband, and ignores me. He faxes in the RX’s no matter what I say. So I stop them at the pharmacist counter.

And no, I am not a hypochondriac, I have a huge file folder with all the test to back up the results. That is one thing I found out the hard way, make them give you copies of ALL test.

Since Oct I’ve had 3 trips to the ER, 2 to the Minor Med, 1 UN-necessary ear surgery, which left me with less hearing than I had before, and pain in the opposite ear for life. Can’t sue, you have to sign waivers. And you are told it is the only way to cure Vertigo and Meniere’s. BULL no cure, made it worse.

On top of all the Uro trips and test for false UT test results at the internist. Been one Heck of a wild ride since last July.


13 posted on 05/28/2012 6:30:48 AM PDT by GailA (Any congress critter or president who FAILS to keep faith with the Military, WON'T keep faith with U)
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To: reformedliberal
As I read the bill, it strengthens the need to prove willful and knowing intent to cause harm AND it disarms the agency. It allows an oat cereal to state that studies show oat fiber can reduce cholesterol or that prune juice can be laxative. That is not wholesale allowing of snake oil. Oat fiber or prune juice will not kill or even injure you and if you want to drink raw milk, that is not the purview of government. Yes, the individual drinking the milk _could_ become ill, but they aren’t going to cause an epidemic. Millions of us have ingested clean milk direct from a bulk tank or from a cow and lived to tell the tale. I am one of those.

As things are, the FDA only steps in when the claims are not supported by solid published scientific studies. And the language of the claims is limited: my box of Quaker Oats says that "3 grams of soluble fiber...may reduce the risk of heart disease" (emphasis mine). Without those limitations, we'd see all kinds of fantastic, scientifically unsupported claims made about various foods.

As for drinking raw milk without ever getting ill from it, that is just a matter of chance. The reason for the heavy regulation of raw milk in the ~20 states that even allow its sale is that, relative to the amount consumed, raw milk is associated with more food poisoning outbreaks than any other food product.

OTOH, the fine print on many drugs is difficult to read and requires a medical dictionary to decipher. Drugs, devices and treatments are regularly passed by the FDA that later turn out to have debilitating and life threatening side effects. Recourse is expensive and class actions only benefit the attorneys. There is no real protection because of FDA.

The nature of clinical trials means that adverse effects that occur at a rate of ~1/1000 or less probably won't be picked up during a clinical trial. For that reason, a fourth clinical trial is conducted after drug/device approval, which is meant to catch those rarer adverse effects. Plus, there are reporting mechanisms that alert the FDA to the need for specific investigations. Another consideration would be the risk/benefit ratio. The FDA isn't perfect, but it is still the best mechanism we have for ensuring that the benefits of any drug/device sufficiently outweigh its risks. I hate to think what would happen if we didn't have the FDA acting as a central regulatory agency for these things. Trying to prove that a drug is harmful would be nearly impossible without having accessible data on side effects and so forth. Trying to prove that a drug does or doesn't have the claimed effect would also be nearly impossible without scientific data. The Libertarian notion that such adverse effects would be adequately addressed by the free market may be romantic, but it never actually happened (which is why the FDA was created). You only have to look at China to see what happens in an unregulated environment.

Normal food production and processing inspections miss many instances where numbers of individuals are sickened, permanently harmed or killed by pathogens. These are failures of the food inspection process that are not addressed in this bill.

Are those failures the fault of the inspectors who check whether the farm/factory/stores/restaurants are storing and processing food products in accordance with the scientifically developed regulations? Or are those failures the fault of farmers/manufacturers/grocers/restaurateurs who flout the regulations and basically ignore food safety? The regulations are written to reflect the latest scientific information on food safety. The USDA and FDA inspectors can only do so much to ensure that the regulations are being followed. And then, when they are trying to ensure basic food safety, they're accused of "attacking innocent practices."

I've been to several American Society of Microbiology meetings. After going to those meetings and seeing presentations discussing various challenges of food safety, I've come to realize that it takes a HUGE effort to provide a safe food supply. A single small mistake anywhere within the production/distribution chain can negate the efforts of everyone else involved in that particular chain, which could be hundreds of individuals. Food safety is not a trivial matter!

14 posted on 05/28/2012 7:02:56 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: exDemMom

“Ugh, this one needs to go down in flames. I would hate to go back to the days where anyone could sell anything, caveat emptor, and injured people had no recourse.”

The present “solution” to these concerns leads us to a government first presumes the power to tell me what I can and cannot ingest thus violating one of my may unalienable rights.

Second, it leads to a government that is willing to kill people who are selling unapproved vitamins or raw milk. Well, government doesn’t really intend to kill them, but during raids by machine-gun equipped SWAT troops, accidents can happen.

Third, it protects commercial interests who are favored by that same gun-wielding bureaucracy via regulatory capture.

Fourth, it leads to false claims of harmless substances when the bureaucracy that enforces its monopoly on competence tells us that there is nothing to worry about, we should just move on with our lives, when in fact a real hazard exists.

See for example: FDA claims no need to test Pacific fish for radioactivity.
http://www.adn.com/2011/04/16/1813982/fda-claims-no-need-to-test-pacific.html#ixzz1JlrzUS7x

and:
http://www.zerohedge.com/article/fda-refuses-test-fish-radioactivity-government-pretends-radioactive-fish-safe

Sixth: this bureaucracy becomes self-serving. Companies that work within the system and are cooperative with it get protection. For example, the CDC estimates that in 2011 contaminated food caused approximately 47.8 million illnesses, over 127,800 hospital admissions and over 3,000 deaths.

But we don’t send a SWAT squad to Jack in the Box when contaminated beef causes several deaths, we send a team of biologists. Had that same number of people died after eating organic beef from an organic farmer in Arkansas, the SWAT raid would have been broadcast live.

see: Spending Big at the Ag Department
http://www.zerohedge.com/contributed/2012-05-27/spending-big-ag-department

Now certainly the public health is an important issue. However, government is only force and as George Washington observed, like fire in that it was a wonderful servant but a terrible master. The present structure of protecting the public costs a lot of lives and part of the media-government collusion is to protect government from the public seeing how much damage it does in the process of protecting us.

One solution is for government to set standards based on sound science and prudent practices but to limit its power to simply requiring labeling as to how well a product complies with the standard. We don’t have to threaten people with machine guns (and risk actually killing them) in order to stop their ability to sell to the public.

Even with my proposal we all must realize there are limits to government, another fact that government bureaucrats just cannot understand. This fact is proved by crack addicts every day.

To a gun-wielding bureaucrat every power of government is there for him to use and his budget only gets bigger when he can use those powers. Government only can grow at the expense of our liberty and prosperity. Our government is way too large and way too expensive as it is.


15 posted on 05/28/2012 7:17:39 AM PDT by theBuckwheat
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To: theBuckwheat

Let me add that the case of the deaths from contaminated beef at Jack in the Box is a great example of how product liability claims have a far greater effect on corporate behavior than the regulators, who were doing their job at the very moment the beef was being contaminated.


16 posted on 05/28/2012 7:21:49 AM PDT by theBuckwheat
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To: exDemMom

I am not arguing against food or drug safety. I know several producers, a former veterinarian meat inspector and a couple of registered food scientists who work in quality control. I have relatives who are medical clinicians and scientists working for pharmaceutical companies.

The fault(s) are shared. Unfortunately, any regulatory scheme only deals with things after the fact, after the contamination has been discovered, either by the QA person or after an outbreak.Notifying the public during or after an outbreak is preferable to no notification at all, but can only work to close down the source after the fact. Further injury may be prevented, but injury has still occurred.

I believe that the push from the public for local sources and basic foods(not processed) has come about because of a distrust of large conglomerate producers and processors. Everyone understands the economics of scale,however, there are many steps in the chain of production and processing that appear vulnerable to contamination, regardless of an FDA.

If I understand you correctly, drugs, supplements, devices and treatment protocols are approved prior to large scale real world *testing* via distribution to the public (Stage Four). This perhaps needs to be rethought. I have taken one undergraduate course in microbiology, over 50 years ago, but I do remember that even there, there was a time lag between culturing and getting the results. Perhaps that has changed w/technology. However, it does appear that much of this regulation depends upon reacting after the fact. Certainly, this can be improved upon.

It has been over 35 years since I consumed bulk tank milk. My family drank it for 4 years or so, until the rules changed. We checked out each producer with local vets, with other dairy farmers and other consumers. We visually inspected the premises. We brought out own sterilized containers. I was aware, as are all such consumers, of the inherent dangers. The responsibility was mine. As I recall, there was never a hint of food-borne illness back then from responsible producers.

Accidents happen, even with a massive regulatory bureaucracy. Arming these bureaucrats seems excessive. I see no problem with the law requiring proof of willful intent and disarming of the regulatory inspectors/enforcers.

Life is full of risks. Everyone needs to be responsible. Armed intimidation stops no outbreak, no side effect nor defective device. Much of the regulatory process appears to be theater. I still must be a savvy consumer. I will not purchase those huge tubes of ground beef from huge processors. In my kitchen, I assume chicken is contaminated before cooking. I do not consume raw eggs, although, growing up in the 40s and 50s, everyone occasionally did so. People ate steak tartare regularly, as well.No one ever feared fresh greens until well after this regulatory agency came into existence. I do not purchase or consume drugs with extensive black box warnings. I have done so in the past and was less than satisfied with my clinician’s response to my adverse experiences. I examine all information available on supplements and have still had adverse, individualistic reactions. I do not expect some massive bureaucracy to keep me safe. I do not presume that a gun in the hands of people who want to limit the average citizen’s access to firearms will keep anyone safe.


17 posted on 05/28/2012 7:47:23 AM PDT by reformedliberal
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To: theBuckwheat
The present “solution” to these concerns leads us to a government first presumes the power to tell me what I can and cannot ingest thus violating one of my may unalienable rights.

You can eat whatever you want--if you want to eat raw nightshade berries picked fresh from your garden, you can do so. The FDA and USDA, however, will prevent you from selling them as a health food. Their job is to make sure that food products offered for sale meet a certain level of safety requirements.

Second, it leads to a government that is willing to kill people who are selling unapproved vitamins or raw milk. Well, government doesn’t really intend to kill them, but during raids by machine-gun equipped SWAT troops, accidents can happen.

Wow, talk about hyperbole.

Although I can't say I see anything wrong with sending someone who intentially sells unsafe contaminated products in wilful disregard of safety and health regulations to prison.

Third, it protects commercial interests who are favored by that same gun-wielding bureaucracy via regulatory capture.

Huh? Do you mean those commercial interests like the local farmers and ranchers who comply with local, state, and federal laws and sell their products at local farms and markets? Is there any reason they *shouldn't* be protected?

Fourth, it leads to false claims of harmless substances when the bureaucracy that enforces its monopoly on competence tells us that there is nothing to worry about, we should just move on with our lives, when in fact a real hazard exists.

Please tell me, what is the "real hazard"? Am I to presume, because of the nature of the articles you linked, that the scientific assessment that it is not necessary to test west coast fish for radioactive contamination from a plant several thousands of miles away somehow adds up to a "real hazard" being ignored?

Sixth: this bureaucracy becomes self-serving. Companies that work within the system and are cooperative with it get protection. For example, the CDC estimates that in 2011 contaminated food caused approximately 47.8 million illnesses, over 127,800 hospital admissions and over 3,000 deaths.

So, companies that practice Good Manufacturing Processes to ensure that their products are safe to consume are "protected" by the system (by which I assume you mean they aren't being shut down)? Why is that a problem? With so many foodborne illnesses, it doesn't make sense to argue for more lax standards.

One solution is for government to set standards based on sound science and prudent practices but to limit its power to simply requiring labeling as to how well a product complies with the standard. We don’t have to threaten people with machine guns (and risk actually killing them) in order to stop their ability to sell to the public.

The people making the regulations *are* scientists, working with the most comprehensive and current scientific data available. I don't see a problem with it. OTOH, restricting regulatory authority to simply requiring labeling of products while allowing anyone to sell anything won't protect anyone. So what if half the dairy cattle at that farm have tuberculosis and the other half carry E. coli H157O7--the raw milk they're selling at their unrefrigerated roadside stand is clearly labeled "Raw milk--may contain pathogens", so it's okay! And no one can sue them, either, since their label meets legal requirements! Oy.

18 posted on 05/28/2012 8:23:31 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: exDemMom
The people making the regulations *are* scientists, working with the most comprehensive and current scientific data available.

Some of these 'scientists' are working for competing pharma's. $$$$$$$$

19 posted on 05/28/2012 8:38:54 AM PDT by aimhigh
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To: exDemMom
trying to report it is near impossible

That is incorrect. Pharmaceutical companies devote a lot of resources to documenting and reporting adverse events.

This is an area for which they can have a drug pulled from the market for inadequate reporting.

If you have any complaints a company's phone service is trained on forwarding anything that sounds like a complaint to their vigilance group. Those folks are skilled at listening, reporting and follow-up. So your point about being difficult to report an adverse event is not accurate.

20 posted on 05/28/2012 8:47:45 AM PDT by corkoman (Release the Palin!)
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To: exDemMom

>>
You can eat whatever you want—if you want to eat raw nightshade berries picked fresh from your garden, you can do so.
<<

Oh, if this were only true, but sadly it is not. If I find pot on my property, it is against the law for me to smoke it, not that I want to. If I find magic mushrooms it is against the law for me to eat them, again not that I want to or would suggest it a good idea for anyone else do eat them.

The French economist Bastiat told us that economics is about the totality of the effects of an action, both the seen and the unseen. Further, people who love big and bigger government never think that their beloved bureaucracies could ever be banal, incompetent, hard-headed, biased or just plain wrong. They always attribute only selflessness and a clean-hearted desire to carry out the law that is only meant for our common well-being. We give them guns to make sure their decrees are carried out but they would never use them wrongly.

I am tempted to claim that liability issues have been far more effective in improving the safety of food and medical products than any government action. But if the example of Jack in the Box’s contaminated beef is of no interest then you would not care to consider any other references that I might provide to back this claim up. I am not fooled by the facade and mirage of competence of any government agency. I do not waive any of my unalienable rights when it comes to the sovereignty of my own body. And thanks to the net I have just as much access to the latest research as any government bureaucrat does.

In my youth, it was not uncommon to hear the rejoinder, “its a free country”. I no longer hear that any more because it is not a free country. My father in law died to preserve his granddaughter’s freedom. If he could see the Leviathan State today, I am not sure he would volunteer for that duty again.


21 posted on 05/28/2012 10:05:48 AM PDT by theBuckwheat
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To: exDemMom

“The FDA isn’t perfect, but it is still the best mechanism we have for ensuring that the benefits of any drug/device sufficiently outweigh its risks.”

You have immense and misplaced trust in the FDA. There are so many studies and commentaries on how the FDA is riddled with conflicts of interest. The board members of FDA are mostly former employees of pharmaceutical companies.

Look how the drug companies are allowed to leave out studies which show side effects and non-efficacy. FDA approval has become a complete joke.

Look at how many drugs were introduced after approval and later turned out to be deadly under normal use. Then it turns out that the negative information was known before approval.

The FDA needs serious reform. At least Rand Paul understands that.


22 posted on 05/28/2012 3:06:16 PM PDT by webstersII
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To: webstersII
You have immense and misplaced trust in the FDA. There are so many studies and commentaries on how the FDA is riddled with conflicts of interest. The board members of FDA are mostly former employees of pharmaceutical companies.

FDA board memberships are a matter of public record, and are readily available at the FDA website. On the current FDA Science Board, I only see one person listed as a pharmacologist, and he is actually a university professor. I do not see a single person whose professional qualifications suggest past employment at a pharmaceutical company. The FDA makes public the laws and regulations regarding who may sit on a committee, and there is a specific guidance that addresses conflicts of interest. If people with a financial interest in the outcome of any drug review panel's decision choose to misrepresent themselves so as to gain membership on the panel, they are breaking the law--you can't claim that the FDA condones or supports their actions.

Look how the drug companies are allowed to leave out studies which show side effects and non-efficacy. FDA approval has become a complete joke.

They're not "allowed" to leave out studies. Companies that choose to omit relevant data are, in fact, breaking the law. You can't blame the FDA for criminal acts committed by persons not affiliated with the FDA.

Look at how many drugs were introduced after approval and later turned out to be deadly under normal use. Then it turns out that the negative information was known before approval.

Please provide a list of these drugs, along with the evidence that the FDA was complicit in allowing companies to flout the law so as to gain regulatory approval.

Since stage 3 clinical trials typically enroll from 1,000 - 3,000 patients, it is very likely that a drug that causes lethal complications in 1 out of 10,000 patients won't be caught during clinical trials. That is why there is a post-approval stage 4 trial, and the FDA maintains an adverse event reporting system. The fact that FDA withdraws approval from drugs that later turn out to be too risky in relation to the benefit they provide is an indication that the FDA is doing its job.

Anyone developing a drug with intent to gain regulatory approval is required to register the clinical trials with the FDA. These trials are all publically available at www.clinicaltrials.gov. Likewise, you can examine all the relevant regulations, procedures, etc., etc., at the FDA website. It is, IMHO, a very user friendly site.

The FDA needs serious reform. At least Rand Paul understands that.

The only "reform" I would agree that the FDA needs is actually a reform of the politicians trying to use the FDA to force people to conform to a diet the politicians approve of. Trying to control the amount of salt or saturated fat one consumes is way outside of the FDA's regulatory purview and constitutional mandate, and should remain so.

I've also looked at Rand Paul's proposal, and see a combination of grandstanding and relaxing of current regulations. If you're upset that it is possible for companies to break the law and misrepresent their drug to the FDA to gain approval, it makes no sense that you would want the regulations weakened--logically, you'd want mechanisms for stronger enforcement of the regulations. Rand Paul's "Part I: Health Freedom Act" weakens the regulations with this provision: Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food to be misbranded only when its label includes a claim adjudicated to be false and/or misleading. That would mean that the FDA would actually be required to go to court to force manufacturers to remove false claims from their product. Under current regulations, the FDA sends a warning letter, giving the manufacturer the option of voluntarily changing their product labeling; only if the manufacturer persists in making false claims will the court route be taken. By requiring that the court route be the first recourse, many manufacturers will be able to get away with false claims, since the court option is time-consuming and costly, limiting the number of false claims the FDA can actually deal with.

A couple of examples of Rand Paul's grandstanding are these, also found in "Part I":

■ Stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements.
■ Stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.

The FDA does not censor truthful claims. A claim that is supported by solid peer-reviewed studies (which are publically databased over at www.PubMed.org) won't be censored. For example, the Quaker Oats company is well within its legal right to claim that consumption of soluble fiber (such as that found in oats) may help heart health, because numerous peer-reviewed studies support that claim. Nor does the FDA prohibit the distribution of scientific articles and publications. These are all publically available through PubMed. There may be copyright issues with distributing scientific literature without the consent of the copyright owner--but that concerns a different governmental agency, not the FDA.

23 posted on 05/29/2012 4:42:57 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: exDemMom
You have immense and misplaced trust in the FDA. There are so many studies and commentaries on how the FDA is riddled with conflicts of interest. The board members of FDA are mostly former employees of pharmaceutical companies.

Funny, isn't it, how many people think that what is commonly known must, therefore, be true?

Some of the FDA's problems may actually result from having folks that don't know enough about what they're attempting to regulate. As far as reform goes, most of the troubles we're having in the United States right now have come as a result of reform movements pushed by progressives and other leftists.
24 posted on 05/29/2012 4:48:30 AM PDT by aruanan
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To: theBuckwheat
The French economist Bastiat told us that economics is about the totality of the effects of an action, both the seen and the unseen. Further, people who love big and bigger government never think that their beloved bureaucracies could ever be banal, incompetent, hard-headed, biased or just plain wrong. They always attribute only selflessness and a clean-hearted desire to carry out the law that is only meant for our common well-being. We give them guns to make sure their decrees are carried out but they would never use them wrongly.

There is a middle ground between an all-powerful authoritarian government and the libertarian ideal of no government at all. The challenge is to keep government agencies restricted to their constitutional functions while giving them enough power to perform those functions. I don't think many people object to the FDA, USDA, and EPA acting within the scope of their narrowly defined missions. As far as I can tell, the objections arise when liberal politicians appoint socialist ideologues to head these agencies, who then eagerly use the agencies' resources to enforce an authoritarian agenda. Because I support the FDA's mission to ensure a safe food supply and want it to have the teeth to perform its mission does not mean I want FDA goons showing up at restaurants and forcing chefs to stop using salt. Ditto with the EPA--it is simply wrong to use regulatory mechanisms meant to minimize air pollution to try to shut down industries that unavoidably produce CO2 as a by-product.

I am tempted to claim that liability issues have been far more effective in improving the safety of food and medical products than any government action. But if the example of Jack in the Box’s contaminated beef is of no interest then you would not care to consider any other references that I might provide to back this claim up. I am not fooled by the facade and mirage of competence of any government agency. I do not waive any of my unalienable rights when it comes to the sovereignty of my own body. And thanks to the net I have just as much access to the latest research as any government bureaucrat does.

This is a little bit complicated to answer. The legal profession has a role, in that lawyers enforce the liability laws, but the lawyers themselves don't have the statistical or scientific analytical skills to determine whether, for example, an adverse event following the use of a prescription drug is actually related to the drug use or is coincidental. I also do not see how lawyers could write effective liability laws regarding technical products without a great deal of scientific input.

As far as the example of contaminated beef at Jack in the Box goes, I really didn't see a need to comment. All issues of contamination that cause serious illness are investigated, at least by state officials, and by federal officials if necessary. And how do we know that an issue warrants investigation? Because food-borne illnesses serious enough to cause someone to seek medical attention are reported to state authorities, who then report the illnesses to the CDC. And state and federal scientists then examine the circumstances of the illness to determine if it is an isolated event (which may not warrant an investigation) or part of a pattern (in which case an investigation is initiated). (Yes, state and federal CDCs track just about every medical complaint--patient anonymity is preserved--look up the MMWR, it's where that info is published.)

Yes, you do have the net. Do you know how to assess whether the information you find on the net is valid or not? Can you discern which of these two websites www.rawmilk.org or www.realrawmilkfacts.com is presenting profit-motivated scientific quackery and which one is presenting accurate scientific data? I'm afraid that without some sort of regulation and government oversight, the legitimate info would completely disappear in the sea of quackery. As it is, it's difficult enough for a layperson to find the legitimate info. Oh, and one way to tell if the info is legitimate is through the references--most quacks make a great deal out of one reference that fits their story, but most legitimate info is supported by many references, with almost every sentence footnoted.

25 posted on 05/30/2012 4:53:09 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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