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.