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S1082 - WHAT IS REALLY GOING ON AT THE FDA

 

 

By Byron J. Richards, CCN

May 7, 2007

NewsWithViews.com

In May of 2006, after months of research and investigation, I published my ominous findings in the book Fight for Your Health: Exposing the FDA’s Betrayal of America. Everything I predicted in this book is on the fast track to becoming reality. A majority of Americans, not informed on current events and unaware of the history involved, are silent. Mainstream media, one of Big Pharma’s largest clients, is silent. Only the power of the internet, which rivals the invention of the printing press in significance, is making it possible for individuals to understand what is going on.

Americans are sick and tired of unelected bureaucrats, such as the management of the FDA, usurping our constitutional rights, suppressing our choices, interfering with commerce, and forcing on us a predetermined path that lines the pockets of the multinational corporations known as Big Pharma. The American people must wake up so that we do not consistently repeat the same mistakes that were made by our parents and grandparents, mistakes that created the current dilemma. We cannot and must not pass these problems on to our children and grandchildren.

Yet, before us this very day, the Senate is proposing sweeping changes (S1082) that will affect the FDA, Big Pharma, and Big Biotech for the next 50 years. This legislation is as significant as the original creation of the FDA. I wish I could say that these changes were mostly positive, but that is just not the case. Many of the real problems are being completely ignored. Under the pretense of improved consumer safety, this legislation seeks to lock in the Big Pharma monopoly called the sickness industry – even taking it to a whole new level. S1082 is a major tool that will assist the FDA, Big Pharma, and Big Biotech in their overall plan to suppress, eliminate, or buy up all safe and effective natural health competition.

In order to empower the American public to understand what is going on, I am releasing my book, Fight for Your Health, to be read online FREE OF CHARGE. Right now is a moment in time, a window of chance, which is rapidly closing. We must understand and learn from the mistakes of the past and forge a different future. Your voice matters. We can make a difference. Unlike Humpty Dumpty, we can put our country, our constitution, our communities, and our freedoms back together again. Health freedom is fundamental to all other freedoms. Rise up and be heard. Click on this link to read Fight for Your Health.

S1082 – User Fees - An Unhealthy Financial Arrangement

Now that “we the people” have been able to slow down the speed at which Kennedy and Enzi were attempting to sneak this sweeping package of FDA reform through the Senate, it gives us some time to analyze what is really taking place. At the very top of the list is the purported premise that is driving this legislation – the need to renew or change a current law called PDUFA (Prescription Drug User Fee Act). This law, originally put in place during the Clinton administration to help speed the approval of new drugs, is now a monster out of control.

PDUFA allows the very wealthy drug companies to pay fees to the FDA in order to have their drugs fast-tracked through FDA approval. There are numerous cases of the safety concerns of FDA scientists being overridden by FDA management to meet the time deadlines required by the PDUFA legislation. Additionally, such large sums of money coming from so few companies enables those companies to have considerable say in how they will be regulated. This is a major conflict of interest as well as a major safety issue. Last year Big Pharma paid the FDA 250 million in user fees, over 50% of the FDA’s budget for new drug approvals. Under S1082 this problem is made worse, raising Big Pharma contributions to 380 million, well over 50% of the FDA budget for new drug approvals.

Shockingly, ALL SENATORS have decided that this arrangement is just fine. What gives these Senators the right to perpetuate such a safety scam and conflict of interest on the American people? How can any Senator claim S1082 is true and meaningful safety legislation when one of the key problems driving safety concerns is made worse! This is total hypocrisy. I am amazed that Congress can come up with 100 billion dollars a year to fund a war in Iraq but can’t fund the FDA to correctly evaluate the safety of new drugs (and even more importantly – the safety of drugs already on the market).

To make matters worse, the Durbin amendment to S1082 (#1022, which passed on a vote of 94-0), directs the Secretary of Health and Human Services to conduct a study to figure out how to implement user fees in the food industry (which includes dietary supplement companies). I can tell you right now that unlike Big Pharma user fees, these user fees will drive up the cost of food and dietary supplements and run many smaller businesses out of business. Such money would have to be collected from many thousands of small companies as a form of tax, and in the case of dietary supplement companies will become part of an intentional FDA-harassment campaign to brand safe and effective dietary supplements as drugs. An underlying primary goal of the FDA is to help Big Pharma eliminate competition from the market. These user fees will be used in conjunction with draconian Adverse Event Reporting legislation that Hatch snuck through the Senate last year in the wee hours of the Lame Duck session.

Our government should fund the FDA for adequate inspection of the safety of the food supply, including and especially food imports. The FDA should not become the next IRS. We need less bureaucratic bumbling with our freedom, not more.

In essence, the Senate’s desire to encourage the expansion of user fees to Big Pharma and its desire to expand them to the food industry is a sign that the Senate can no longer do its job of proper financial appropriations. By dumping government responsibility onto the private sector, not only is a costly bureaucratic nightmare created, but in the case of drugs – SERIOUS SAFETY ISSUES AND CONFLICT OF INTEREST ISSUES ARE PERPETUATED. This is one reason every American should flood the Senate calling for a no vote on S1082.

The Anti-American FDA

Most people think the FDA management is busy looking out for drug and food safety to help protect American citizens from harm. Few people understand that FDA management and Big Pharma are on the same page, often a revolving door in terms of employment, AND FDA MANAGEMENT IS ACTIVELY TAKING ACTIONS TO UNDERMINE THE RIGHTS OF THE CITIZENS IN THIS COUNTRY. Bill S1082 does absolutely nothing to stop this major assault on the intentional FDA erosion of citizen’s rights.

FDA has deviously worked with Big Pharma to create case law precedent around the country that forces the FDA to hide safety issues from the public so as not to expose the “trade secrets” of Big Pharma. How this happened is fully explained in Fight for Your Health. It is important to understand that the FDA has intentionally gone out of its way to create a situation that keeps American citizens in the dark – and the proposed S1082 does not change this. Furthermore, the FDA has taken the position that citizens of the United States of America should have NO RIGHTS to sue a drug company in state court when a drug injures or kills them. FDA is seeking to undermine the balance of power between the states and the federal government, while at the same time shooting down fundamental rights of citizens.

In essence, FDA is taking a fascist/totalitarian approach. Why? Partly to prevent law suits and save Big Pharma money. And mostly because the FDA is planning on becoming a drug company and using its software as the centerpiece for the design of all new drugs through its Critical Path Initiative and the S1082-proposed Reagan-Udall Foundation for the FDA.

What happens when new FDA-designed drugs start injuring and killing people? If citizens have the right to sue when they have been injured they will in fact be suing the FDA. The FDA’s “solution” to this problem is to wipe out citizen’s rights. The FDA is saying that if they do the testing and give their stamp of approval, then the public should trust that the FDA did an honest job of ensuring safety and thus give up any rights of recourse - regardless of what happens. First of all, nobody trusts the FDA. Second of all, this plan is insane. Yet, it is exactly what is being pushed off on us by the FDA. S1082, as written, not only ignores this issue entirely but gives FDA management dramatically more power and creates the Reagan-Udall Foundation for the FDA to implement the plan.

Furthermore, FDA management is acting with a political agenda to forward globalization at the expense of health freedom in the United States. The FDA is actively helping to forge the North American Union through its illegal Trilateral Cooperation Charter with Mexico and Canada. If you have not already signed the petition demanding Congressional oversight on this issue, please do so by clicking on this link. The FDA is also seeking to harmonize United States laws to draconian Codex guidelines relating to dietary supplements so as to help eliminate competition for Big Pharma. This is also fully explained in Fight for Your Health.

The important point to understand is that FDA management is acting politically AND WITHOUT CONGRESSIONAL MANDATE OR AUTHORITY to undermine the laws in our country – including an outright attack on our constitution and sovereignty. FDA is actually helping to carry out the globalization agendas of both the Clinton and Bush administrations, administrations that have both been owned by Big Pharma. Thus, there is no turning to one or the other political party to solve these problems – it can only be solved by Americans uniting together to stand up for our rights and preserve our national sovereignty and constitution.

Your voice is clearly being heard. And we must keep flooding the Senate.

There are now two letters that need to be e-mailed or faxed, as well as calling in to let your Senator’s know your feelings. The first letter relates to The People’s Amendment, which must be in place if this horrid package of legislation becomes law. It has been updated to reflect the fact that Durbin has put the word “food” into the legislation in multiple places. The second letter relates to being opposed to the legislation in general.

To get information on contacting your Senators, click here:

Letter #1 - The People’s Amendment:

S.1082 - Please Amend to Protect Dietary Supplements

May 7, 2007

The Honorable (Senator First and Last Name)

Address
Address

Dear Senator Last Name;

The issue of drug safety is of the utmost importance to myself and all Americans. I am concerned that the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use S.1082 to undermine my access to safe and effective dietary supplements.

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 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.

I am sure you and other Senators were not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with a simple amendment.

Proposed amendment to S1082:
“The bill, S1082, is hereby amended to eliminate any reference to the terms food or food ingredients within Subtitle B - Reagan-Udall Foundation for the Food and Drug Administration, such that food and food ingredients will not be subject to any jurisdiction or control by the Reagan-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.

Sincerely,

Letter #2 – General opposition to S.1082

Anti S.1082 - Prescription Drug User Fee Amendments of 2007 (formerly the Food and Drug Revitalization Act)

May 7, 2007

The Honorable (Senator First and Last Name)

Address
Address

Dear Senator Last Name;

The issue of drug safety and access to drugs at a fair price is of the utmost importance to myself and all Americans. In general, I am opposed to Senate bill S1082: Prescription Drug User Fee Amendments of 2007, as it does not go far enough to protect myself and my family from the dangers of drugs.

I am opposed to Big Pharma funding of the FDA. I want Congress, not private industry, to fund new drug approval as well as the safety of drugs already on the market. It is an intolerable conflict of interest AND SAFETY ISSUE to have Big Pharma paying the FDA to approve its own drugs.

I want an independent office within the FDA to monitor the safety of drugs already on the market. FDA scientists must be free of all FDA management pressures and Big Pharma influence. I am in favor of all 11 Grassley amendments.

I support the Dorgan amendment that enables Americans to get a fair price on prescription medication.

I am opposed to the Reagan-Udall Foundation for the FDA, which supports the plans of the Critical Path Initiative, a plan that is officially on record wanting to speed new and even more powerful drugs to the market with far less safety and effectiveness testing than current medications.

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It is intolerable that Congress does not properly fund the FDA to approve new drugs, monitor the safety of drugs, and ensure a safe food supply. It is also intolerable that FDA management problems, as outlined in the Institute of Medicine report (which calls FDA management dysfunctional) are not being meaningfully addressed.

S.1082 is Big Pharma preferred legislation. I want true and meaningful safety legislation that protects myself and my family. Please vote no on S1082.

Sincerely,

Related articles:

1, S1082 - The Voice of the People is Being Heard
2,
Senators Bribed by Big Pharma vs. Senators not Bought Off 5-2-07
3, Dietary Supplements Threatened, Freedom in Danger 4-30-07
4, U.S. Health Freedom on Verge of Collapse 4-25-07

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Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, and educator. He is the author of Mastering Leptin, The Leptin Diet, and Fight for Your Health: Exposing the FDA's Betrayal of America.

Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. As founder of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement company since 1985, he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com

E-mail: byron@truthinwellness.com

 


 

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I want an independent office within the FDA to monitor the safety of drugs already on the market. FDA scientists must be free of all FDA management pressures and Big Pharma influence. I am in favor of all 11 Grassley amendments.