Health Freedom Action

Oppose/Amend HR 1561

Health Freedom in the Hands of the House Now. Tell Your Representative to Protect You, Not Big Pharma, Before It is, Literally, Too Late!

The Senate of the United States passed S. 1082 on May 9, 2007 with just one dissenting vote. Now the House of Representatives is up to bat.

The House will vote on identical legislation, HR 1561, and can kill the bill, amend it or pass it just as it comes from the Senate.

Your health hangs in the balance. Reading through the suggested letter prepared for you to send to your Representatives by the Natural Solutions Foundation you can see that there are a number of dangerous Big Pharma Give-Aways in this dangerous and highly destructive bill.

Please take the time to send this letter, or your own version of it, to your Representatives and let them know that this is a matter of critical importance to you and that you WILL be watching their performance.

After you send your letter by clicking on the "Send" link below, please take a moment to forward this information to everyone in your circle of influence and urge them to take action and then forward this action item to everyone THEY know. Volume of response is our best, and at this point, our ONLY tool for maintaining and protecting our health from the predatory and often literally life threatening FDA!

By the way, if your submission does not work (and we our links do get interfered with quite often) please send an email to dr.laibow@gmail.com with "SUBMIT-1561" in the subject line and your full name and address in the body of the email and we will submit for you.

Thanks for your activism!

We are the ones we have been waiting for. Our Senators certainly are not!

Yours in health and freedom,

Dr. Rima

Rima E. Laibow, MD

Medical Director

Natural Solutions Foundation

www.HealthFreedomUSA.org

>>Learn More

November 22, 2009

Subject:

Dear Representative:

HR 1561: FDA Revitalization Act

I am writing at the suggestion of the Natural Solutions Foundation to urge you in the strongest possible terms to reverse the damage done to the health and health freedom of the American people by Senate bill S1082 and its sister bill HR 1561: Food and Drug Administration Revitalization Act (passed by the Senate on May 9, 2007).  I urge you to vote "NO!" to defeat this dangerous bill.  If not defeated, it must be amended to protect the health and safety of the American people and their health freedoms, now seriously threatened by the Senate's adoption of this legislation.

S. 1082/HR 1561 fails to protect food and Dietary Supplements, generally regarded as foods, by protecting only DSHEA products, and leaving foods, compounded products, nutraceuticals, compound and bioidentical substances and functional foods without protection.

As a consumer of Dietary Supplements, I am deeply concerned that S. 1082 will give the FDA expanded regulatory power to undermine the spirit and letter of the Dietary Supplement Health and Education Act of 1994. S. 1082/HR 1561 authorizes, on pages 106-107 of S. 1082, 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. The terms “food” and “food ingredients” must be totally removed from this legislation. Removing these terms will make it clear that 1) 1082's House counterpart. HR 1561, and the resulting Compromise Bill are to govern only the safety of drugs and that 2) the safety of food and food ingredients is already governed by different laws which are in no way superseded by 1082/HR 1561.

In the event there is no way to stop the passage of HR 1561, then at least amended the bill to avoid any possibility that dietary supplements will be evaluated as drugs.  The Natural Solutions Foundation supports the following amendments
1. Amendment suggested by Jonathan Emord, J.D.:

Purpose of the amendment:
The bill, HR 1561: 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 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.

Amendment 2:
Congressman Ron Paul's strong protection of meaningful health claims, embodied in H. R. 2117, should be included in this bill as an amendment in it entirety to protect the right of consumers to know what the beneficial impacts of dietary supplements of all types may be for them.  Please support the inclusion of this important language as an amendment to this bill.

The Natural Solutions Foundation also strenuously objects to other components of this legislation, and feels that the House version, if passed, of S. 1082 should reflect the following changes:

1. The Reagan-Udall Foundation for the Food and Drug Administration component of the bill should be completely eliminated.  This section would turn the FDA into a drug development company that will expose Americans to new and dangerous drugs that have little testing to prove safety or effectiveness.  A regulator should not become, or have any affiliation with, a market participant!

2. HR 1561 proposes an increase in drug company funding of the FDA’s drug approval process.  The already ill-conceived “user fees” upon which the FDA is increasingly dependent for its operating budget, which will be substantially increased under this bill's provisions.  This means that this important regulatory agency will become even more subservient to its financial source rather than independently and thus able to serve as a public watch dog in the publics’ interest.  This fee structure already a major source of corruption and ultimately, of unnecessary costs and hundreds of thousands of preventable deaths in this country.  Increasing the FDA's dependence on this financially incestuous source of funding will simply make the problem worse at an accelerating cost of human suffering and agency corruption.

3. Members of the FDA advisory panels should have no financial, professional or other ties to the drugs being reviewed or the companies testing, manufacturing or marketing them.  This distance should be rigorously enforced and civil, professional and criminal penalties should be instituted to assure any such breech of public trust.

4. HR 1561 allows drug companies to hide unfavorable clinical trial results.  Drug companies must be required to fully disclose all information relating to the drugs.  Under the current regulatory situation, tremendous harm has come to light through complicity of the drug companies and the people who are tasked with regulating them.  HR 1561 makes this complicity a matter of legal permission rather than the corrupt handshake deal it is now.

5. Safety experts within the FDA must be totally free from management pressures.  The American Public has the right to expect and rely upon the findings of an independent office within the FDA with authority and meaningful resources to monitor the safety of the single greatest killer in the United States: properly prescribed pharmaceutical drugs which are already on the market and new ones as they are brought forward by the pharmaceutical industry.  Existing FDA management has proven time and again to lack transparency on the issue of post marketing drug safety and to regard obvious conflicts of interest as all in a day's work --and pay-- for the men and women who allegedly protect America from unreasonably dangerous drugs.

I look forward to your vigorous and highly health freedom protective efforts on behalf of voters like me and my neighbors, the people who have asked you to accept the honor or representing us in the United States House of Representatives.  We will all be watching closely.

Yours in health and freedom,

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