WHAT IS REALLY GOING ON AT THE FDA?

[Guest guest]

By Byron J. Richards, CCN

 

May 7, 2007

 

NewsWithViews.com

 

In May of 2006, after months of research and investigation, I

published my ominous findings in the book Fight for Your Health:

Exposing the FDA's Betrayal of America. Everything I predicted in

this book is on the fast track to becoming reality. A majority of

Americans, not informed on current events and unaware of the history

involved, are silent. Mainstream media, one of Big Pharma's largest

clients, is silent. Only the power of the internet, which rivals the

invention of the printing press in significance, is making it

possible for individuals to understand what is going on.

 

Americans are sick and tired of unelected bureaucrats, such as the

management of the FDA, usurping our constitutional rights,

suppressing our choices, interfering with commerce, and forcing on

us a predetermined path that lines the pockets of the multinational

corporations known as Big Pharma. The American people must wake up

so that we do not consistently repeat the same mistakes that were

made by our parents and grandparents, mistakes that created the

current dilemma. We cannot and must not pass these problems on to

our children and grandchildren.

 

Yet, before us this very day, the Senate is proposing sweeping

changes (S1082) that will affect the FDA, Big Pharma, and Big

Biotech for the next 50 years. This legislation is as significant as

the original creation of the FDA. I wish I could say that these

changes were mostly positive, but that is just not the case. Many of

the real problems are being completely ignored. Under the pretense

of improved consumer safety, this legislation seeks to lock in the

Big Pharma monopoly called the sickness industry – even taking it to

a whole new level. S1082 is a major tool that will assist the FDA,

Big Pharma, and Big Biotech in their overall plan to suppress,

eliminate, or buy up all safe and effective natural health

competition.

 

In order to empower the American public to understand what is going

on, I am releasing my book, Fight for Your Health, to be read online

FREE OF CHARGE. Right now is a moment in time, a window of chance,

which is rapidly closing. We must understand and learn from the

mistakes of the past and forge a different future. Your voice

matters. We can make a difference. Unlike Humpty Dumpty, we can put

our country, our constitution, our communities, and our freedoms

back together again. Health freedom is fundamental to all other

freedoms. Rise up and be heard. Click on this link to read Fight for

Your Health.

 

S1082 – User Fees - An Unhealthy Financial Arrangement

 

Now that " we the people " have been able to slow down the speed at

which Kennedy and Enzi were attempting to sneak this sweeping

package of FDA reform through the Senate, it gives us some time to

analyze what is really taking place. At the very top of the list is

the purported premise that is driving this legislation – the need to

renew or change a current law called PDUFA (Prescription Drug User

Fee Act). This law, originally put in place during the Clinton

administration to help speed the approval of new drugs, is now a

monster out of control.

 

PDUFA allows the very wealthy drug companies to pay fees to the FDA

in order to have their drugs fast-tracked through FDA approval.

There are numerous cases of the safety concerns of FDA scientists

being overridden by FDA management to meet the time deadlines

required by the PDUFA legislation. Additionally, such large sums of

money coming from so few companies enables those companies to have

considerable say in how they will be regulated. This is a major

conflict of interest as well as a major safety issue. Last year Big

Pharma paid the FDA 250 million in user fees, over 50% of the FDA's

budget for new drug approvals. Under S1082 this problem is made

worse, raising Big Pharma contributions to 380 million, well over

50% of the FDA budget for new drug approvals.

 

Shockingly, ALL SENATORS have decided that this arrangement is just

fine. What gives these Senators the right to perpetuate such a

safety scam and conflict of interest on the American people? How can

any Senator claim S1082 is true and meaningful safety legislation

when one of the key problems driving safety concerns is made worse!

This is total hypocrisy. I am amazed that Congress can come up with

100 billion dollars a year to fund a war in Iraq but can't fund the

FDA to correctly evaluate the safety of new drugs (and even more

importantly – the safety of drugs already on the market).

 

To make matters worse, the Durbin amendment to S1082 (#1022, which

passed on a vote of 94-0), directs the Secretary of Health and Human

Services to conduct a study to figure out how to implement user fees

in the food industry (which includes dietary supplement companies).

I can tell you right now that unlike Big Pharma user fees, these

user fees will drive up the cost of food and dietary supplements and

run many smaller businesses out of business. Such money would have

to be collected from many thousands of small companies as a form of

tax, and in the case of dietary supplement companies will become

part of an intentional FDA-harassment campaign to brand safe and

effective dietary supplements as drugs. An underlying primary goal

of the FDA is to help Big Pharma eliminate competition from the

market. These user fees will be used in conjunction with draconian

Adverse Event Reporting legislation that Hatch snuck through the

Senate last year in the wee hours of the Lame Duck session.

 

Our government should fund the FDA for adequate inspection of the

safety of the food supply, including and especially food imports.

The FDA should not become the next IRS. We need less bureaucratic

bumbling with our freedom, not more.

 

In essence, the Senate's desire to encourage the expansion of user

fees to Big Pharma and its desire to expand them to the food

industry is a sign that the Senate can no longer do its job of

proper financial appropriations. By dumping government

responsibility onto the private sector, not only is a costly

bureaucratic nightmare created, but in the case of drugs – SERIOUS

SAFETY ISSUES AND CONFLICT OF INTEREST ISSUES ARE PERPETUATED. This

is one reason every American should flood the Senate calling for a

no vote on S1082.

 

The Anti-American FDA

 

Most people think the FDA management is busy looking out for drug

and food safety to help protect American citizens from harm. Few

people understand that FDA management and Big Pharma are on the same

page, often a revolving door in terms of employment, AND FDA

MANAGEMENT IS ACTIVELY TAKING ACTIONS TO UNDERMINE THE RIGHTS OF THE

CITIZENS IN THIS COUNTRY. Bill S1082 does absolutely nothing to stop

this major assault on the intentional FDA erosion of citizen's

rights.

 

FDA has deviously worked with Big Pharma to create case law

precedent around the country that forces the FDA to hide safety

issues from the public so as not to expose the " trade secrets " of

Big Pharma. How this happened is fully explained in Fight for Your

Health. It is important to understand that the FDA has intentionally

gone out of its way to create a situation that keeps American

citizens in the dark – and the proposed S1082 does not change this.

Furthermore, the FDA has taken the position that citizens of the

United States of America should have NO RIGHTS to sue a drug company

in state court when a drug injures or kills them. FDA is seeking to

undermine the balance of power between the states and the federal

government, while at the same time shooting down fundamental rights

of citizens.

 

In essence, FDA is taking a fascist/totalitarian approach. Why?

Partly to prevent law suits and save Big Pharma money. And mostly

because the FDA is planning on becoming a drug company and using its

software as the centerpiece for the design of all new drugs through

its Critical Path Initiative and the S1082-proposed Reagan-Udall

Foundation for the FDA.

 

What happens when new FDA-designed drugs start injuring and killing

people? If citizens have the right to sue when they have been

injured they will in fact be suing the FDA. The FDA's " solution " to

this problem is to wipe out citizen's rights. The FDA is saying that

if they do the testing and give their stamp of approval, then the

public should trust that the FDA did an honest job of ensuring

safety and thus give up any rights of recourse - regardless of what

happens. First of all, nobody trusts the FDA. Second of all, this

plan is insane. Yet, it is exactly what is being pushed off on us by

the FDA. S1082, as written, not only ignores this issue entirely but

gives FDA management dramatically more power and creates the Reagan-

Udall Foundation for the FDA to implement the plan.

 

Furthermore, FDA management is acting with a political agenda to

forward globalization at the expense of health freedom in the United

States. The FDA is actively helping to forge the North American

Union through its illegal Trilateral Cooperation Charter with Mexico

and Canada. If you have not already signed the petition demanding

Congressional oversight on this issue, please do so by clicking on

this link. The FDA is also seeking to harmonize United States laws

to draconian Codex guidelines relating to dietary supplements so as

to help eliminate competition for Big Pharma. This is also fully

explained in Fight for Your Health.

 

The important point to understand is that FDA management is acting

politically AND WITHOUT CONGRESSIONAL MANDATE OR AUTHORITY to

undermine the laws in our country – including an outright attack on

our constitution and sovereignty. FDA is actually helping to carry

out the globalization agendas of both the Clinton and Bush

administrations, administrations that have both been owned by Big

Pharma. Thus, there is no turning to one or the other political

party to solve these problems – it can only be solved by Americans

uniting together to stand up for our rights and preserve our

national sovereignty and constitution.

 

Your voice is clearly being heard. And we must keep flooding the

Senate.

 

There are now two letters that need to be e-mailed or faxed, as well

as calling in to let your Senator's know your feelings. The first

letter relates to The People's Amendment, which must be in place if

this horrid package of legislation becomes law. It has been updated

to reflect the fact that Durbin has put the word " food " into the

legislation in multiple places. The second letter relates to being

opposed to the legislation in general.

 

To get information on contacting your Senators,

 

Letter #1 - The People's Amendment:

 

S.1082 - Please Amend to Protect Dietary Supplements

 

May 7, 2007

 

The Honorable (Senator First and Last Name)

 

Address

Address

 

Dear Senator Last Name;

 

The issue of drug safety is of the utmost importance to myself and

all Americans. I am concerned that the legislation, as currently

written, opens the door for considerable regulatory confusion

enabling the FDA to use S.1082 to undermine my access to safe and

effective dietary supplements.

 

There must be no confusing the safety of drugs and the safety of

food and food ingredients – which are governed by different laws.

This bill authorizes the creation of a new regulatory category that

enables the FDA and the Reagan-Udall Foundation for the FDA to

attack dietary supplements and functional foods.

 

I am sure you and other Senators were not intending to create such

concern among the 150 million Americans who rely on dietary

supplements to assist their health, and this matter is easily

corrected with a simple amendment.

 

Proposed amendment to S1082:

" The bill, S1082, is hereby amended to eliminate any reference to

the terms food or food ingredients within Subtitle B - Reagan-Udall

Foundation for the Food and Drug Administration, such that food and

food ingredients will not be subject to any jurisdiction or control

by the Reagan-Udall Foundation for the Food and Drug

Administration. "

 

Intent of amendment:

To eliminate from the bill any possibility that food or food

ingredients would be treated like drugs either for safety review

purposes or for assessment of their efficacy. It is a fundamental

tenet of food and drug law that foods and food ingredients are

presumed to be safe and have to be established to be adulterated

only if they present a significant or unreasonable risk of illness

or injury.

 

Sincerely,

 

Letter #2 – General opposition to S.1082

 

Anti S.1082 - Prescription Drug User Fee Amendments of 2007

(formerly the Food and Drug Revitalization Act)

 

May 7, 2007

 

The Honorable (Senator First and Last Name)

 

Address

Address

 

Dear Senator Last Name;

 

The issue of drug safety and access to drugs at a fair price is of

the utmost importance to myself and all Americans. In general, I am

opposed to Senate bill S1082: Prescription Drug User Fee Amendments

of 2007, as it does not go far enough to protect myself and my

family from the dangers of drugs.

 

I am opposed to Big Pharma funding of the FDA. I want Congress, not

private industry, to fund new drug approval as well as the safety of

drugs already on the market. It is an intolerable conflict of

interest AND SAFETY ISSUE to have Big Pharma paying the FDA to

approve its own drugs.

 

I want an independent office within the FDA to monitor the safety of

drugs already on the market. FDA scientists must be free of all FDA

management pressures and Big Pharma influence. I am in favor of all

11 Grassley amendments.

 

 

 

I support the Dorgan amendment that enables Americans to get a fair

price on prescription medication.

 

I am opposed to the Reagan-Udall Foundation for the FDA, which

supports the plans of the Critical Path Initiative, a plan that is

officially on record wanting to speed new and even more powerful

drugs to the market with far less safety and effectiveness testing

than current medications.

 

 

 

It is intolerable that Congress does not properly fund the FDA to

approve new drugs, monitor the safety of drugs, and ensure a safe

food supply. It is also intolerable that FDA management problems, as

outlined in the Institute of Medicine report (which calls FDA

management dysfunctional) are not being meaningfully addressed.

 

S.1082 is Big Pharma preferred legislation. I want true and

meaningful safety legislation that protects myself and my family.

Please vote no on S1082.

 

Sincerely,

 

Related articles:

 

1, S1082 - The Voice of the People is Being Heard

2, Senators Bribed by Big Pharma vs. Senators not Bought Off 5-2-07

3, Dietary Supplements Threatened, Freedom in Danger 4-30-07

4, U.S. Health Freedom on Verge of Collapse 4-25-07

 

© 2007 Truth in Wellness, LLC -

 

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Byron J. Richards, Founder/Director of Wellness Resources, is a

Board-Certified Clinical Nutritionist and nationally-renowned health

expert, radio personality, and educator. He is the author of

Mastering Leptin, The Leptin Diet, and Fight for Your Health:

Exposing the FDA's Betrayal of America.

 

Richards encourages individuals to take charge of their health,

stand up for their health rights, and not blindly succumb to

propaganda from the vested-interests who profit from keeping

Americans sick. As founder of Wellness Resources, Inc. of

Minneapolis, MN, an independently-owned fine-quality dietary

supplement company since 1985, he has personally developed 75 unique

nutraceutical-grade nutritional formulas. www.wellnessresources.com

 

E-mail: byron

 

 

 

 

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