- CCN 5-6-7 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."
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- Major Problem #1 A Fair Price for Drugs
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- 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).
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- Major Problem #2 A Fake Safety Bill
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- 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.
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- 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 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.
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- 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.
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- 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:
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- 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?
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- 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.
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- 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.
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- 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.
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- SEN. HATCH.: That explanation is very helpful. What,
specifically, would the role of the Foundation be with respect to dietary
supplements?
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- 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.
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- 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 deficiencies through collaborative research with industry.
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- 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?
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- 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?
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- SEN. KENNEDY: Yes, that is the case.
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- SEN. ENZI: I agree with Chairman Kennedy's assessment.
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- SEN. HATCH: I thank you for those assurances and that
clarification.
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- 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.
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- 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.
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- 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?
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- 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.
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- 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).
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- 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).
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- 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
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- Anti S.1082 Food and Drug Revitalization Act
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- May 5, 2007
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- The Honorable (Senator First and Last Name)
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- Address Address
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- Dear Senator Last Name;
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- 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.
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- 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.
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- 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
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- Purpose of the amendment:
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- 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.
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- Intent of amendment:
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- 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.
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- Sincerely,
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- To get information on contacting your Senators follow
this link: http://www.senate.gov/general/contact_information/senators_cfm.cfm
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