Major Expansion of FDA Powers will Target
Dietary Supplements
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). 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 (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). In previous versions 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 government. 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."
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 [S1082] 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."
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 and S.
467: Fair Access to Clinical Trials Act of 2007. 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."
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 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
- 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.
- 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.
- Sign this petition demanding congressional oversight
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.
This
article has been reprinted with permission from 21st Century Organics.
