By Byron J. Richards, CCN

April 30, 2007

NewsWithViews.com

Bill S1082: The Food and Drug Administration Revitalization Act (also called the Prescription Drug User Fee Act of 2007) is one of the greatest scams and con jobs ever foisted on the American public. Current FDA management is grossly incompetent on the subject of drug safety. This new legislation drastically increases FDA management’s power. Each day innocent citizens die at the hands of Big Pharma – oftentimes while the FDA hides known risks and condones the very drugs that cause harm – all in the name of profit at the expense of human health. See my extensive analysis of this legislation.

Bill S1082 pretends to address drug safety while in fact proposing a set of laws that helps hide existing risks while ushering in the next generation of extreme drug risk (the Critical Path Initiative). At the same time the bill dramatically broadens FDA regulatory power to attack dietary supplements and health freedom.

On the afternoon of April 30, a Unanimous Consent Agreement on S1082 is scheduled for 4:15 PM eastern time. Senator Kennedy, who is in charge of the HELP committee that has sent this bill to the Senate floor, is seeking to fast track this legislation through the Senate on a voice vote before anyone figures out what he is doing. Kennedy reported in the Congressional Record on April 24 that he filed a committee report on S1082; however, when the HELP committee office was contacted late Friday they were unaware of any report and did not have one - WHICH MEANS THAT ALMOST NO SENATOR WHO IS EXPECTED TO VOTE ON MONDAY TRULY KNOWS WHAT IS IN THIS BILL. Kennedy is seeking to run a secret government and bypass the Advise and Consent Clause of Article Two of the United States Constitution. This is not democracy.

As things stand right now, the bill is expected to pass by voice vote based on the propaganda of Kennedy, Enzi, Clinton, and many others. This is a bipartisan hoodwinking of the American public being paid for by Big Pharma. Big Pharma and the dysfunctional FDA management have spent over two years crafting this bill. Not only does the bill fail to solve key drug safety issues, IT TURNS THE FDA INTO A DRUG DEVELOPMENT COMPANY.

Immediate action is required in the Senate, and if the bill should pass, in the House. E-mail, phone, and fax your Senators and Representatives – please do all three! Big Pharma is spending millions to pass this legislation. It is up to the American people to stop it. Also see the additional action step following the sample letter.

To get information on contacting your Senators follow this link:

To get information on your Congressperson in the House of Representatives follow this link:

Here is a sample letter you can use:

Anti S.1082 Food and Drug Revitalization Act

April 30, 2007

The Honorable (Senator or Representative First and Last Name) Address Address

Dear Senator (or Dear Representative) Last Name;

The issue of drug safety is of the utmost importance to myself and all Americans. I am totally opposed to Senate bill S1082: Food and Drug Administration Revitalization Act, as well as any companion bill that is introduced in the House. I am dismayed that the HELP committee has not provided a report on this bill for your staff to study and that you are not aware of many dangerous consequences within this legislation. As one of the 150 million Americans that rely on dietary supplements to keep myself and my family well, I am especially concerned that this legislation broadens FDA regulatory power to harass functional foods and dietary supplements – which has nothing whatsoever to do with drug safety.

It is vital that the terms “food” and “food ingredients” be removed from this legislation. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. This bill authorizes, on pages 106-107, the creation of a new regulatory category that enables the FDA and the Reagan-Udall Foundation for the FDA to attack dietary supplements and functional foods. Often, I feel that the FDA is working to protect Big Pharma and eliminate safe and effective natural health options. By removing the terms food and food ingredients from this legislation there can be no confusion of drug regulation with food regulation.

Indeed, there are many shortcomings in this legislation. The following points need a much more open and public debate, and thorough testimony in the Senate:

1. There should be an end to Big Pharma funding the FDA for new drug development. There is no other situation in government where those needing regulation are allowed to pay the regulating agency and dictate how they will be regulated. This is a major conflict of interest that reduces drug safety. S1082 proposes an increase in such Big Pharma funding of the FDA. This is unacceptable.
2. Members on FDA advisory panels should not be allowed to have financial ties to the drugs being reviewed. This is a major conflict of interest. We need full disclosure of all clinical trial results – especially the ones that did not go well. S1082 allows Big Pharma to not report unfavorable results. I want full and complete disclose in the name of safety.
3. I much prefer an independent office within the FDA to monitor the safety of drugs already on the market. Existing FDA management has proven time and again to lack transparency on the issue of post marketing drug safety. Safety experts within the FDA must be totally free from management pressures.
4. I believe that legislation that places the FDA in the drug business should be considered on its own, as a separate bill. Especially since the Critical Path technology is based on the idea of speeding drugs to the market even faster with far less safety and effectiveness testing than the current drugs which are already causing such concern. In the spirit of true and meaningful safety reform, The Reagan-Udall Foundation for the Food and Drug Administration (pages 105-125), should be evaluated at another time.

S1082 is seeking to do far too much without true and meaningful FDA reform. Minimally, I want the terms “food” and “food ingredients” removed from this legislation. However, I ask you to vote no on the entire bill, because, as written, it will not prevent another Vioxx catastrophe.

Sincerely,

Additional Action Step

In addition to the above letter it is important to call Senator Hatch (202-224-5251) and Senator Harkin (202-224-3254) and leave a message telling them that you are very concerned that bill S1082 will gives the FDA new power to undermine DSHEA (Dietary Supplement Health and Education Act) and that you request they insert the following amendment into the legislation to avoid any possibility that dietary supplements will be evaluated as drugs. (Note: This language has been prepared by Jonathan Emord – leading health freedom attorney).

Amendment to Bill S1082

Purpose of the amendment:
The bill, S1082: The Food and Drug Administration Revitalization Act, is hereby amended to eliminate any reference to the terms food or food ingredients, such that food and food ingredients will not be subject to any jurisdiction or control by the Regan-Udall Foundation for the Food and Drug Administration.

Intent of amendment:
To eliminate from the bill any possibility that food or food ingredients would be treated like drugs either for safety review purposes or for assessment of their efficacy. It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury

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