FDA Final Rule

[Guest guest]

June 29 2006

newstarget.com

The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity

(opinion)

June 30, 2006 is a day that will be long remembered as a dark milestone in

the history of FDA and its campaign against health consumers. On June 30, an

FDA " Final Rule " goes into effect, establishing a regulatory power grab of

such scale and scope that it attempts to bypass all laws, the will of

Congress and fundamental protections for consumers. This " Final Rule, " which

may as well be called a " Final Solution " for drug consumers, claims that

consumers can no longer sue drug companies for the harm caused by any

FDA-approved drug, even if the drug's manufacturer intentionally misled the

FDA by hiding or fabricating clinical trial data.

In one blatantly illegal act, the FDA is attempting to pull off the greatest

Big Pharma coup of all: The outright elimination of any responsibility

whatsoever for the suffering and death caused by deadly pharmaceuticals.

In the preamble of the FDA's new " Final Rule " to take effect on June 30, the

agency asserts that FDA approval of prescription drugs -- and their implied

safety -- may no longer be second-guessed by consumers or organizations of

any kind. The FDA's stamp of approval, the agency claims, is an absolute

declaration of safety of all such drugs, for any use whatsoever, including

off-label use (the use of drugs on health conditions that were never tested

in clinical trials).

But such a position has no basis in law. During a June 6, 2006 hearing, a

New Jersey state court judge Carol E. Higbee characterized the FDA's

preamble as, " a political statement by the FDA " and explained that the ploy

has, " ...nothing to do with science. ...It is contrary to the U.S. Supreme

Court's decisions. It is contrary to all the law on preemption. ... In

addition to being contrary to the law of the land, it is also contrary to

the Constitution of the United States. "

The FDA is dangerous to America

That this outrageous assertion by the FDA would take place at a time when so

many Americans are routinely killed by the harmful side effects of

prescription drugs only contributes to the arrogance and absurdity of this

rogue agency that has now become the No. 1 threat to the health and safety

of the American people. Even a terrorist nuclear attack on a major U.S. city

would not equal the number of Americans who have already been killed by the

negligent actions of the FDA.

FDA-approved prescription drugs injure 2.2 million and kill approximately

100,000 Americans each year, according to peer-reviewed published studies,

and more realistic estimates put the number of deaths at over 200,000 people

annually in the United States alone (see Death By Medicine for detailed

statistics). Vioxx, according to senior FDA drug safety researcher Dr.

Graham, appears responsible for the deaths of over 60,000 Americans, and

further deaths due to beta blockers, antidepressant drugs, statins and other

medications continue to mount by the hour.

The resulting FDA body count of American casualties makes the casualties of

war look small in comparison. The Vietnam War claimed the lives of

approximately 50,000 Americans (plus many more Vietnamese), and a memorial

in Washington D.C. honors those who died. But FDA-approved prescription

drugs have killed well over a million Americans, yet no memorial will be

built, no honors bestowed, and now the FDA would deny the families of those

victims their legal right to fight for any sort of compensation.

It's not like these consumers were killed by enemy gunfire in a foreign

land; they were killed by American companies, on American soil, with the

full permission and approval of an American regulatory agency! The enemy

from within is, indeed, far more dangerous than any foreign threat to the

lives of American citizens. Not since World War II have so many Americans

died from a single, common, preventable cause, and it almost seems that the

FDA has declared war on the American people and is using chemical weapons to

win that war.

The scourge of dangerous prescription drugs, combined with willful collusion

at the FDA, has now created a chemical holocaust on U.S. soil that will

continue to claim the lives of mothers, fathers, daughters and sons until

the American people demand that justice be served and that the FDA /

pharmaceutical industrial complex be dismantled and condemned through some

modern-day equivalent of the Nuremberg Trials. How many millions more have

to die from this chemical holocaust before this reign of medical terror is

brought to an end?

The ramifications of the FDA's Final Rule

The FDA's new " Final Rule " would allow drug companies to operate with

impunity, shouldering absolutely no responsibility for the harmful (even

fatal) side effects of their prescription drugs, many of which we are now

learning were only approved under highly suspicious circumstances that smack

of fraud, corruption and outright criminal intent. Consumers harmed or

killed by toxic prescription drugs -- even drugs that their manufacturers

knew were extremely dangerous -- would have no recourse whatsoever.

If such a rule were to go unchallenged, the degree of profiteering by Big

Pharma would be unprecedented. Free to charge monopoly prices thanks to the

FDA-enforced domestic drug racket that outlaws international competition,

and unburdened by the financial risk of lawsuits from consumers harmed by

their drugs, Big Pharma would be emboldened to unleash a dystopian era of

unprecedented disease mongering, bribery of doctors, false advertising and

the mass drugging of children, adults and seniors alike... with absolutely

nothing to hold them in check.

This result may, in fact, have been the intention all along. This " Final

Rule " appears to be little more than a thinly-veiled attempt to establish

wide-ranging authority where none exists by burying it in the language of a

drug labeling rule. A more detailed legal criticism is offered by

Barth Menzies, an attorney at Baum Hedlund in Los Angeles:

On Wednesday, Jan.18, 2006, the Food and Drug Administration issued new

regulations regarding the labeling of prescription drugs, including

regulations aimed at providing doctors and patients with clearer information

about the risks associated with prescription drugs. However, in the preamble

to these new regulations, the FDA inserted conclusory and legally

unsupported statements that tort lawsuits alleging a failure to warn of

known or reasonably knowable safety risks are preempted by federal law. This

attempted power-grab by the FDA wholly ignores the prerogative of Congress,

contradicts both statutory and case law precedent, disregards the parallel

but distinct roles played by FDA and tort liability law, fails to provide an

avenue through which consumers may be compensated for drug-induced injury,

neglects any federal replacement of applicable state policing and

enforcement procedures, and shirks constitutionally established principles

of federalism which protect the jurisdiction granted to states in matters

involving public safety and health. By inserting preemption language into

the Final Rule without an official consultation with state and local

government groups concerning the preemption language, the FDA also violated

Executive Order (E.O.)13132. (When an Executive department or agency

proposes to act through adjudication or rule-making to preempt State law,

the department or agency shall provide all affected States notice and an

opportunity for appropriate participation in the proceedings. Exec. Order

No. 13132, [[4(e), 64 Fed.Reg. 43255, 43257 (1999). According to the

National Conference of State Legislatures (NCSL), the preemption language

inserted into the preamble of the Final Rule is a thinly veiled attempt on

the part of FDA to confer upon itself authority it does not have by statute

and does not have by way of judicial ruling. The NCSL called FDA s action an

abuse of agency process and a complete disregard for our dual system of

government.

The fallout of the FDA's " Final Solution "

The ramifications of this " Final Rule " action by the FDA cannot be

overstated. If this rule is allowed to stand, it represents the end of

health justice, the end of the power of Congress, and the surrender of

absolute power to an agency of such arrogance and evil that it has conducted

armed raids on vitamin clinics, organized the raid of a church, and even

ordered the destruction of recipe books it didn't want to see published.

(Supporting documents are available for all of these statements).

The FDA, through its willful negligence, is indirectly responsible for the

deaths of more Americans than all terrorists, murderers and drunk drivers

combined. As the deaths continue to mount, and drug companies become even

more aggressive with outlandish disease mongering and advertising efforts,

the FDA rears up to unleash a new wave of corporate terrorism upon the

American people by emboldening drug companies to care even less about the

safety of their synthetic chemical products, most of which cause harm by

their very nature of being foreign to the human body.

As Menzies explains:

Pharmaceutical industry lobbying efforts and zealot tort reformers have

sired a new wave of brazen attempts to shield drug manufacturers from tort

liability. The preemption language in the preamble to the Final Rule is but

the latest attempt. Preemption has become the argument du jour and

politically appointed regulatory officials the mouthpieces. The crafty

messages sound of consumer protection, but are just the opposite. Limiting

the liability of drug companies will not improve public safety. The FDA's

purported position on preemption assumes that the FDA is infallible and that

negligent misconduct by pharmaceutical companies should be the sole purview

of FDA. Recent regulatory failures demonstrate that FDA is neither

infallible nor does it have the capability of policing drug manufacturers

negligent misconduct.

Want to see the real FDA at work? Read the story of Rezulin, and you'll be

shocked to learn the truth about the real agenda that drives this rogue

agency.

The end is near for the Big Pharma / FDA racket

Why would the FDA engage in such an obviously unlawful power grab? Because

Big Pharma co-conspirators have realized that lawsuits threaten to bankrupt

the drug companies. The products of these companies are so universally

harmful, and their ability to hide this truth is slipping away so rapidly,

that the financial burden of settling lawsuits (or defending them in court)

threatens to crush the entire pharmaceutical empire.

Merck alone is defending itself against literally thousands of lawsuits from

just one drug: Vioxx. As the truth emerges about the dangerous side effects

from the long-term use of other widely-prescribed drugs, class action

lawsuits will reach a momentum that will make the Big Tobacco settlements

seem like a friendly game of Friday-night poker.

Truth be told, there is not enough money in the world to pay for all the

pain, suffering and death that has already been caused by prescription

drugs, and if drug companies are held responsible for even a small fraction

of the patients their products have harmed and killed, they will rapidly

fall from the most wealthy corporations in the world to the most bankrupt,

both financially and morally.

And so the FDA is jumping in with one last, desperate attempt to cast a

spell of immunity over all drug companies in order to preempt the coming

flood of class action lawsuits. But even this effort will fail, as the truth

about the dangers of prescription drugs can no longer be censored. Through a

tidal wave of new books, documentaries and health websites, consumers are

learning the shocking truth about Big Pharma and the FDA, and the beginning

of the end of the age of chemical medicine is already under way.

Reading suggestions: The Truth About the Drug Companies by Marcia Angell,

M.D., Psyched Out by O'Meara, or Death by Prescription by Ray

Strand.

You see, the arrogance and greed of drug companies will ultimately be their

downfall. They have pushed too hard, too far, and they have landed

themselves in a realm of such obvious scientific fraud and criminal

negligence that the backlash is inevitable. The rampant disease mongering,

the mass drugging of schoolchildren with amphetamines, the false claims of

drug ads, the bribery of doctors, the collusion at the FDA... it's all

coming to the surface now, and by the time this house of cards comes

tumbling down, the resulting criminal trials against drug company executives

and FDA officials will make the Enron trials sound like a high school

debate.

It is not only inevitable that drug company executives and FDA senior

officials will do prison time for their crimes against humanity, it is

important that they be loudly condemned via such punishments for knowingly

defrauding, harming and ultimately killing countless Americans in exchange

for one thing: Corporate profits.

American medicine is now the shame of the world, and the conduct of senior

officials at the FDA is nothing less than criminal. There is now no greater

threat to the health and safety of the American people than the U.S. Food

and Drug Administration.

" As currently configured, the FDA is not able to adequately protect the

American public. It's more interested in protecting the interests of

industry. It views industry as its client, and the client is someone whose

interest you represent. "

- Dr. Graham, senior drug safety researcher at the Food and Drug

Administration, and Vioxx whistleblower

Regards,