Monday, April 30, 2007
This bill is up in the Senate this week. From Lef.org: "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. [...]
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.
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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.
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