|
The Security and Prosperity Partnership (SPP) intends to "harmonize" regulations between Mexico, Canada and the United States, without respect to potential violations of existing U.S. laws. Part of this process affects the drug and supplement industries by adopting the  WTO/WHO Codex Alimentarius, which promises to put the vitamin and health supplement industry under the control of global pharmaceutical corporations. They want ALL your health care dollars. Now, an actual bill called the "Food and Drug Administration Revitalization Act" (S1082), sponsored by Senator Edward Kennedy (D-MA), is on the Senate floor. Read this alarming commentary and pass it on to everyone who values their health freedoms.
By Byron J. Richards, CCN
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.
{sidebar id=1}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 Prescription Drug User Fee Act (PDUFA). 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.
Wellness Resources
|
