S1082: Will FDA Do Away With Pharma's Competition?

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S1082: Will FDA Do Away With Pharma's Competition?

 

http://www.newmediaexplorer.org/sepp/2007/04/26/s1082_will_fda_do_away_with_phar\

mas_competition.htm

 

The FDA and the drug companies have been very close

http://www.newmediaexplorer.org/sepp/2003/06/10/the_fda_and_the_drug_companies_a\

re_getting_awfully_cozy.

htm for some time now, but a new bill, S1082, introduced in the US Senate by

Edward Kennedy and Michael Enzi is proposing to arrange a marriage between

Big Pharma and its regulatory agency. The drug companies bring a rich dowry,

instalments are already being paid through the Prescription Drug User Fee Act

(PDUFA) http://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act which has

allowed the drug companies to provide major funding for the FDA's activities

for some years. Of course in return the FDA had to promise to use that money for

speeding new drugs to market.

 

The new bill, which has already passed the relevant committee and is due to

be considered by the Senate later this year - it is attached to the obligatory

renewal of the PDUFA - goes even further.

 

One comment by Byron Richards:

http://www.truthinwellness.com/blog

 

" It is hard for anyone to comprehend that the agency that is supposed to be

in charge of drug safety is about to become a drug company. It is astonishing

that the FDA will now manage a full scale business activity that uses a “non

profit†foundation as a shield to avoid international patent problems, protect

proprietary rights of its commercial drug-development enterprise, and massively

expands FDA regulatory powers to quickly remove anything from the market that

is competition to its own products and licensing agreements. "

 

The FDA has shown clearly over the last few decades that it is practically

unable to keep Big Pharma in check or protect the health

http://www.newmediaexplorer.org/sepp/2004/11/23/vioxx_shows_fda_unable_to_protec\

t_public_from_deadly_m

edical_drugs.htm of the American public. But as if the situation was not

already serious enough, the FDA " Revitalization Act " as now proposed by Senator

Kennedy seems set to institutionalize the incestuous relationship with the

industry the agency is supposed to control.

 

- - ------

US HEALTH FREEDOM ON VERGE OF COLLAPSE

By Byron J. Richards, CCN

 

April 25, 2007

(Original at NewsWithViews.com

http://www.newswithviews.com/Richards/byron23.htm )

 

A new attack against health freedom, drug safety, and dietary supplements was

launched last week by Senator Edward Kennedy (D-MA) with major support from

Michael Enzi (R-WY). It is called the Food and Drug Administration

Revitalization Act (S1082).

http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf This

legislation was planned over the past few years working hand-in-glove with the

FDA’s dysfunctional management and legal team – meaning this legislation was

written for the profits of Big Pharma and Big Biotech AT THE EXPENSE OF SAFETY

AND HUMAN HEALTH.

 

S1082 is a Trojan Horse bill that pretends to address safety issues.

Unbelievably, the bill turns the FDA into a drug development company that will

expose

Americans to new and dangerous biological drugs that have little testing to

prove safety or effectiveness. And to top it off, the bill gives broad new

regulatory powers to the FDA that can be used to frivolously attack dietary

supplements and forward the FDA management’s anti-American globalization

agenda.

 

On April 18, 2007, S1082 was approved by the HELP committee

http://help.senate.gov/ (which Kennedy and Enzi control) and now moves to the

floor of the

Senate. In a slick move, Kennedy has attached his long-planned FDA/Big Pharma

“

reform†measures to the renewal of PDUFA (Prescription Drug User Fee Act).

Current PDUFA law expires later this year and must be reviewed by Congress.

PDUFA

allows Big Pharma to pay the FDA fees to speed the approval of its drugs. The

new Kennedy bill will increase these FDA bribes to 380 million dollars in 2008,

well over 50% of the FDA budget for new drug approvals. This is like paying

the mob for protection. Kennedy, by replacing the existing PDUFA law with this

new bill (S1082), is ensuring that his twisted legislation is the one that

will be put before the Senate for a vote.

 

The FDA Drug Company, an Agency with New Regulatory Power

 

It is hard for anyone to comprehend that the agency that is supposed to be in

charge of drug safety is about to become a drug company. It is astonishing

that the FDA will now manage a full scale business activity that uses a “non

profit†foundation as a shield to avoid international patent problems, protect

proprietary rights of its commercial drug-development enterprise, and massively

expands FDA regulatory powers to quickly remove anything from the market that

is competition to its own products and licensing agreements.

 

This new FDA business enterprise is called the Reagan-Udall Foundation for

the Food and Drug Administration (see pages 105-125

http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf ). In previous versions

http://www.govtrack.us/congress/billtext.xpd?bill=s109-3807 of the Kennedy bill

it was going to be an

independent drug company within the FDA (the Reagan-Udall Institute for Applied

Biomedical Research). In the current bill it is a “non profit†collaboration

of the FDA, private industry, government funding, and private funding. It is

run directly by the FDA even though it pretends to not be part of the gove

rnment. Under this scam taxpayers will foot the bill for drug development and

then

be charged outrageous prices for the drugs. Furthermore, the new bill seeks

to allow a massive expanse of FDA regulatory power through this new foundation.

For example, on pages 106-107 the bill states:

 

“The purpose of the Foundation is to advance the mission of the Food and Drug

Administration to modernize medical, veterinary, food, food ingredient, and

cosmetic product development, accelerate innovation, and enhance product

safety…

..The Foundation shall [take] into consideration the Critical Path reports and

priorities published by the Food and Drug Administration, identify unmet

needs in the development, manufacture, and evaluation of the safety and

effectiveness, including post approval, of devices, including diagnostics,

biologics,

and drugs, and the safety of food, food ingredients, and cosmetics.â€

 

Through this foundation the FDA is seeking broad new regulatory power that it

currently does not possess. This will include the authority to attack any

dietary supplement (which are food ingredients) as unsafe based on its use of

“

Critical Path†technology. This means the FDA will use proteomics (the

advanced

study of proteins in biological systems) to assess changes in biomarkers (the

change in the state of a protein at the molecular level) in order to establish

whatever it wants to consider as a risk. The FDA can slant this technology,

based on their own personal opinions, to make anything they want appear as a

risk – including your favorite dietary supplements that you use to stay

healthy.

 

 

Deceiving the Public

 

This new bill panders to concerns of Americans regarding the safety of drugs.

This legitimate worry is used by Kennedy and Enzi to garner support when in

reality the bill does just the opposite - exposing Americans to almost

unfathomable new drug risks and dangers while simultaneously making it possible

to

remove super safe, therapeutic, and helpful dietary supplements. The entire

Critical Path initiative is a plan to race new and untested powerful biological

drugs onto the market and experiment on patients all over the country –

throwing

caution to the wind as far as drug safety is concerned.

 

While S1082 also pretends to address the issues of drug safety, in reality

all the needed Big Pharma loopholes are firmly in place. Additionally, the

establishment of a clinical trial database as written in this proposed law will

enable Big Pharma to hide experimental and undesirable side effects. Instead of

full disclosure we will have a sterilized clinical trial database that will

have the net effect of being used as a tool by Big Pharma to promote off label

use of drugs. This is a far cry from disclosure that results in safety.

 

In response to the Kennedy con Charles Grassley (R-IA) immediately attacked

the legislation on the floor of the Senate:

 

“The bill [s1802] does not address the outstanding critical problem that the

office responsible for post-market drug safety lacks the independence, lacks

the authority to promptly identify serious health risks and take necessary

steps that will protect the public. As I think we all agree, the FDA is in

desperate need of major overhaul.â€

 

The problem for Grassley, and all Americans, is that his true safety reform

measures for the FDA are being held hostage by the HELP committee which is

under the control of Kennedy and Enzi. His proposed legislation is S. 468: Food

and Drug Administration Safety Act of 2007

http://www.govtrack.us/congress/bill.xpd?bill=s110-468 and S. 467: Fair Access

to Clinical Trials Act of 2007

http://www.govtrack.us/congress/bill.xpd?bill=s110-467 . As Grassley told the

Senate:

 

“Let me be clear: Big Pharma does not like these bills. FDA management does

not like these bills. Lobbyists are spending hours upon hours lobbying against

these bills…What is wrong with establishing a separate center within the

FDA--not outside the FDA, within the FDA--with its only job being that of a

watchdog for those drugs already in the market?...What is wrong with supporting

a

clinical trial registry and results database that also requires sponsors to

reveal their negative trials?...I propose there is nothing wrong with any of

these

proposals.â€

 

The situation is rather grave for all Americans. Kennedy has attached

repressive legislation to replace the PDUFA funding thereby ensuring that his

agenda

will come before the Senate for a vote. The only real opposition to the

legislation is coming from Grassley, who is attacking the weakness in FDA reform

regarding drug safety and clinical trials. An even greater threat to the public

–

turning the FDA into a drug company and creating new regulatory powers that

can be used to attack dietary supplements and remove them from the market – is

being ignored by everyone – until now. Kennedy knows he can defeat Grassley

and keep Grassley’s bills from ever seeing the light of day. Can Kennedy

defeat

the American public? Solving this problem is up to you.

 

The Secret FDA Agenda – Government Against the People

 

The FDA is a puppet organization. Its management is a revolving door with Big

Pharma, Big Biotech, and Big Agriculture. The behavior of its management

team, set by its current leader Andrew von Eschenbach – but fully entrenched

in

its long and ugly history, is one of acting as a police-force bully to forward

the profits of those with money and stamp out all competition (under the false

guise of consumer protection). The FDA management fully believes it is above

any law http://www.emord.com/events/speeches/fda_violation.htm that is in its

way or any attempt at Congressional oversight. It gives lip service to its

safety mission. It is a cult unto itself.

 

The anti-American FDA is actively seeking to undermine U.S. laws and

harmonize our dietary supplement laws with Mexico and Canada. This is being done

through the Trilateral Cooperation Charter – an illegal agreement set up with

health regulatory agencies in Mexico and Canada. It is part of the campaign

towards

a North American Union, one which would be a catastrophe for health freedom

in this country as dietary supplement laws in Canada and Mexico are far more

restrictive than in the U.S.

 

The FDA would also like to harmonize our dietary supplement laws with the

evolving international standards set by Codex, thus branding therapeutic

nutrition as dangerous and risky and needing to be sold by Big Pharma or removed

from

the market altogether (if it competes with a blockbuster category of drugs).

Codex is planning to use the same proteomics and biomarker technology that will

be used by the FDA’s Critical Path Initiative to remove therapeutic dietary

supplements from the international market and force their policies on America,

thereby superseding the sovereignty of American law on threat of trade

sanctions. The FDA fully supports draconian Codex guidelines to regulate dietary

supplements and is working with the Germans to concoct technology to brand

nutrients as drugs. The FDA management is as bad as any government agency can

get.

Under the leadership of Andrew von Eschenbach it has plummeted to an all time

low.

 

What You Can Do

 

1) Call, fax, phone, and write your Senators and tell them you are opposed to

bill S1082 - Food and Drug Administration Revitalization Act. Tell them you

want no legislation of any kind that will enable the FDA to frivolously attack

dietary supplements. Tell them you do not want Big Pharma funding the FDA with

user fees for drug approvals. Demand an independent office within the FDA to

monitor drug safety. And tell them you want full disclosure by Big Pharma of

all their clinical trials. Tell them you support the Grassley legislation (S467

and S468) which offers true reform of the FDA.

 

2) Tell your Senators you are completely opposed to any law that would enable

the FDA to act as a drug company, such as S1082, which is proposing the

formation of the Reagan-Udall Foundation for the FDA.

 

3) Sign this petition demanding congressional oversight

http://www.thepetitionsite.com/takeaction/373269232?ltl=1177432290 of the

FDA’s Trilateral

Cooperation Charter – a key point the FDA is using to illegally support the

formation of the North American Union while at the same time undermining health

freedom. This is the FDA’s front line attack that undermines American law and

seeks

to harmonize us with the laws of other countries. We must win this battle to

stop Codex and preserve our health freedom – including access to therapeutic

dietary supplements and all alternative health options.

 

 

If S1082 becomes law and the FDA is allowed to enter relationships with

foreign countries without any Congressional mandate or oversight we can kiss

health

freedom goodbye – as well as our dietary supplements. It is time for dietary

supplement companies and trade groups to get their heads out of the sand and

quit jockeying for position in the New World Order at the expense of the future

well being of their own customers.

 

The issue of health freedom is an issue for all Americans who believe in our

constitution and our founding documents. America is the last bastion of health

freedom on earth. If we fall, the world will be plunged into a Dark Ages of

health. Our future health will be dictated by a multinational sickness industry

driven by profits for drug and biologic companies with little to do with real

quality of health. This is a crossroads – a moment in time. Health freedom is

fundamental to all other freedoms as without health freedom the minds and

bodies of a population are easy to control.

 

 

Related Articles:

 

1, FDA Wants to Eliminate Natural Health Care

http://www.newswithviews.com/DeWeese/tom81.htm

 

2,Feds eye control of vitamins, supplements – even water!

http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=55370

 

© 2007 Truth in Wellness, LLC -

 

--

 

posted by Sepp Hasslberger on Thursday April 26 2007

 

 

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