FDA Power Grab in trouble-Keep contacting Senators

[Guest guest]

IAHF List: Please See Byron Richard's latest update on the S.1082 below.

Thanks for your ongoing assistance- please keep making calls and sending faxes

and emails today. The Senate is out of session today, but staff are still

there for you to communicate with.

 

An IAHF ally on Capital Hill is making a concerted effort to try to persuade

Senator Tom Coburn of Oklahoma to introduce the Emord amendment (our

amendment to remove the terms " Foods and Food Ingredients " ) to the bill.

Senator

Coburn is an MD and he is in the dietary supplement caucus. He values

alternative medicine and dietary supplements and has expressed the view that

the high

cost of health care could be reduced if more people were to utilize dietary

supplements for preventive purposes.

 

I am going to need to travel to DC at some point when this legislation gets

into the House, but its too soon to tell when that will be. Please keep in

mind that the Senate and House language ends up being cojoined via whats

called a " Conference Report " and that COMBINED PACKAGE is what gets sent to

the

President's desk for his signature. (All kinds of mischief often happens when

the combine the House and Senate language into one package.) The price of

freedom is eternal vigilance. Donations for airfare and 10 days lodging on the

Hill to insure that we don't get burned in the House and in the Conference

Committee Markup would be very helpful at this time.

IAHF 556 Boundary Bay Rd. Point Roberts WA 98281 USA

Paypal _http://www.iahf.com/index1.html_ (http://www.iahf.com/index1.html)

 

S1082 – The Voice of the People is Being HeardThere is still time to stop

FDA, Inc.

May 5, 2007

By Byron Richards, CCN

NewsWithViews.com

permission to reprint

Bill S1082 is a bill that helps fund the FDA with Big Pharma money. It is

known all over Capital Hill as Big Pharma-designed legislation. It is running

into all sorts of credibility problems. A vote is likely on Monday –

delayed due to all the opposition flooding the Senate by “we the people.â€

Major

Problem #1 – A Fair Price for Drugs.

Realizing that meaningful FDA reform legislation is not likely again for ten

years numerous Senators are backing the Dorgan amendment to S1082. The

amendment enables U.S. citizens to buy drugs from Canada and other

industrialized

nations. This will save us at least 50 billion dollars over the next ten

years and cut the price of many drugs in half. Those opposing the amendment,

which includes most of the major proponents of S1082 and the Bush

administration, are the ones clearly on the payroll of Big Pharma. Their

excuse for not

supporting it is flimsy – that it will cause safety problems. The majority

of Senators are not buying this transparent cover-up. Dorgan won Round 1 of

the voting on his amendment yesterday (63-28), showing that he has the power

to hit Big Pharma where it hurts – in the pocketbook. A final vote on the

Dorgan amendment is expected Monday (keep up support for the Dorgan

amendment). Major Problem #2 – A Fake Safety Bill.

Last year’s Institute of Medicine report labeled FDA management as

dysfunctional causing FDA reform to pick up momentum. To deflect public

outrage S1082

was created by Kennedy and Enzi, in close consultation with the FDA and Big

Pharma. As you might expect from such a meeting of the minds, the bill is

really a Big Pharma-sponsored con job and it actually increases the power of

dysfunctional FDA management.

Unfortunately for Big Pharma and the FDA, Charles Grassley (R-IA), a man

concerned with true and meaningful safety reform, has gone through S1082 with a

fine tooth comb. He has _proposed 11 amendments_

(http://grassley.senate.gov/index.cfm?FuseAction=PressReleases.Detail & PressRelea\

se_id=5369) to close the

Big Pharma loopholes that Kennedy, Enzi, the FDA, and Big Pharma built into

this legislation. Big Pharma and the FDA hate all 11 Grassley amendments and

Big Pharma has its legion of lobbyists trying to defeat them as you read this.

Support the Grassley amendments for true and meaningful safety reform.

Major Problem #3 – A Sneak Attack on Dietary Supplements.

As I have been reporting for the last week, language relating to the

Reagan-Udall Foundation for the FDA creates a new regulatory category and

broadens

FDA power in a way that can be used to attack dietary supplements. In

response to this devious threat, Jonathan Emord, our nations leading health

freedom

attorney, prepared amendment language to nullify the threat – an amendment we

now call The People’s Amendment. Many of you flooded the Senate with your

objections – AND YOUR VOICE IS BEING HEARD.

I have obtained an e-mail message from David Taylor, the president of the

Natural Products Association, which went out to various heads of nutrition

companies – in an effort to get companies not to protest S1082 (dietary

supplement trade groups are not the friends of health freedom). It contained

an

attachment with a transcribed conversation between Hatch, Harkin, Kennedy, and

Enzi about all the phone calls you’ve been making. It shows that Hatch and

Harkin don’t really understand what the Reagan-Udall foundation is, that

Kennedy

and Enzi are lying about what it will do, AND THAT WE ARE GETTING THROUGH.

Here is the text:

SEN. HATCH: My office has been inundated by calls from people throughout

the country who believe that this legislation, specifically the provision

establishing a Reagan-Udall Institute, will overturn the Dietary Supplement

Health

and Education Act of 1994. That has not been my reading of the bill, but I

wonder if other Senators have heard similar concerns?

SEN. HARKIN: Yes, I have received a good many calls as well. And, I have

to say that I would be very concerned, as I know the Senator from Utah is, if

anything in the bill we are considering, S. 1082, would overturn DSHEA, a law

we fought side-by-side to see enacted.

SEN. ENZI: It might be helpful if I explained the provision you are

discussing, as my office has received many calls as well and I believe the

callers

are not informed about this matter. Subtitle B of Title II of S. 1028,

establishes the Reagan-Udall Foundation for the Food and Drug Administration.

That

simple purpose of that non-profit Foundation is to lead collaborations among

the FDA, academic research institutions and industry designed to bolster

research and development productivity, provide new tools for improving safety

in

regulated product evaluation, and in the long-term make the development of

those products more predictable and manageable.

SEN. KENNEDY: That is exactly the purpose of the Foundation, which was

included in the drug safety legislation Senator Enzi and I introduced last

year.

The Foundation will be financially supported by industry and philanthropic

donated funds. A Chief Scientist at FDA will promote intramural research and

coordinate it with efforts at the Foundation.

SEN. HATCH.: That explanation is very helpful. What, specifically, would

the role of the Foundation be with respect to dietary supplements?

SEN. KENNEDY: Let me make absolutely clear that the Reagan-Udall Foundation

will in no way override, overturn or conflict with the Dietary Supplement

Health and Education Act. Nothing in this bill would have that effect.

SEN. ENZI: Yes, we took great pains to make certain there would be no

conflict with DSHEA. Regarding foods, and dietary supplements are generally

regulated as foods, the general directive of the Foundation is to identify holes

in the evaluation of food safety and identify ways to address those de

ficiencies through collaborative research with industry.

SEN. HARKIN: So, to make this absolutely clear, what you are saying is that

the bill we are debating would in no way interfere with consumers’ access to

dietary supplements?

SEN. HATCH: To add to that point, it seems that the language could, in

fact, help dietary supplement consumers, because it would allow collaboration

between government and industry to conduct research on issues that might be

helpful to supplement consumers?

SEN. KENNEDY: Yes, that is the case.

SEN. ENZI: I agree with Chairman Kennedy’s assessment.

SEN. HATCH: I thank you for those assurances and that clarification.

SEN. HARKIN: This has been a very helpful discussion, because Senator Hatch

and I could never support legislation that would interfere with DSHEA and we

are glad to receive the assurances of the Chairman and the Ranking

Republican on the Committee.

This is a major breakthrough – Kennedy and Enzi are now on record stating

this will in no way affect our dietary supplements. And Hatch and Harkin are

on record as being concerned. There are still two problems. 1) Kennedy and

Enzi are hard to trust, based on all the Big Pharma loopholes built into

their bill. 2) The FDA and its lawyers get to interpret what S1082 means once

it becomes law. The FDA could care less what Hatch, Kennedy or Enzi intended

to say. Until the language is fixed it is a problem of magnitude. Major

Problem #4 – The Creation of FDA, Inc.

As you can see from the Kennedy and Enzi comments above, they are portraying

the Reagan-Udall Foundation for the FDA as a benevolent and friendly group

that will facilitate collaboration between the FDA, academia, and private

industry – receiving funding from industry and philanthropic donations –

and oh

yes, let’s not forget the foundation may even help with safety. Do you

really think the FDA needs to create a whole organization to do that? And why

wouldn’t such duties just be the function of a few people or a department

within

the FDA?

It is my opinion that the primary reason for bill S1082 is to create FDA,

Inc. by using the Reagan-Udall Foundation for the FDA. The FDA wants to be in

the drug development and marketing business and is looking for a way to do

it. Most of the issues in S1082 are a smokescreen, keeping Senators like

Grassley busy fighting all the Big Pharma loopholes. So far Kennedy and Enzi

have skillfully created so much diversion that nobody is paying attention to

the

FDA becoming a drug company.

In a nutshell, Andrew von Eschenbach, M.D, head of the FDA, has a long

history of involvement with the cancer-for-profit industry. His resume

includes

being head of the National Cancer Institute, where he routinely diverted

funding from solid cancer science into the pockets of his friends in Big Bio

Tech.

He was also a lead player in an old boy network called C-Change, a group of

the most powerful vested interests in biotechnology and cancer research –

which is headed by George Bush Sr. and his wife, Barbara. It is not surprising

that the current president backs Big Pharma and Big Biotech as he does – his

family wealth depends on it. Drug research and development performed at the

Reagan-Udall Foundation will undoubtedly be paid for, in large part, by

companies who have grants from the National Cancer Institute (taxpayer funds).

 

Von Eschenbach took over the helm of the FDA to create his dream of a cancer

sickness industry wherein nobody actually gets well – they just live

indefinitely in a sick condition on really expensive biotech drugs. This

project is

called the Critical Path Initiative. The FDA has created highly

sophisticated software that can identify protein-molecule changes at the

cellular level.

The FDA wants to use this computer software to design the entire next

generation of powerful biological medicines – making all of private industry

use

its software technology. The Reagan-Udall foundation is the tool that FDA

plans to use for patent protection and licensing arrangements of its technology

with private industry – and thus the creation of FDA, Inc. Von Eschenbach is

on record as stating that the Critical Path Initiative is the FDA’s top

priority (not drug safety or food safety).

The Critical Path Initiative has been repeatedly attacked because it would

expose patients to drugs with far less testing for safety and effectiveness

compared to drugs already on the market. Furthermore, these biologic drugs

will be far more powerful because they throw gene switches in cells – meaning

the risk for adverse events skyrockets. Initially, just patients with no

other medical hope will be the guinea pigs. The FDA wants to run this

technology

in all doctor’s offices around the country – which will require your DNA in

an FDA-owned government database. This is not science fiction – this is

what the FDA is on public record as wanting to do. Keep Taking Action –

Revised

letter

Anti S.1082 Food and Drug Revitalization Act

May 5, 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: Food and Drug Administration Revitalization Act, as it does not

go far enough to protect myself and my family from the dangers of drugs. If it

is to be passed I want all 11 Grassley amendments which are true safety

reform added to the bill. I am also in favor of the Dorgan amendment that

enables Americans to get a fair price on prescription medication.

As one of the 150 million Americans that rely on dietary supplements to keep

myself and my family well, I am especially concerned that this legislation

broadens FDA regulatory power to harass functional foods and dietary

supplements – which has nothing whatsoever to do with drug safety. While

Senator’s

Kennedy and Enzi are telling us not to be concerned – we simply don’t trust

the FDA and want language that protects dietary supplements in this

legislation.

It is vital that the terms “food†and “food ingredients†be removed

from

this legislation. 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. This problem in the wording can be corrected with this

simple amendment – so as to be sure this legislation is about drugs and drug

safety only. Amendment to Bill S1082

Purpose of the amendment:

The bill, S1082: The Food and Drug Administration Revitalization Act, is

hereby amended to eliminate any reference to the terms food or food

ingredients,

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

 

 

 

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