THE HEALTH FREEDOM OF CHOICE ACT

by Dan Haley

1) Regardless of the definition of a drug used by the Food and Drug Administration (FDA), as of the effective date of this Act, FDA is prohibited from exercising jurisdiction over products which are nontoxic or devices which are harmless.

2) Nontoxicity is defined as any substance less toxic than aspirin and is established when a manufacturer submits to the FDA tests from three independent, unrelated, and unconnected testing laboratories certifying that the product which the manufacturer proposes to place in interstate commerce is no more toxic than aspirin.

3) Harmlessness is established when the Underwriters Laboratory certifies as harmless a device which a manufacturer proposes to place into interstate commerce.

4) The FDA may contest such findings of nontoxicity or harmlessness, if it chooses, but it is required to do so within 90 days (as it routinely did before 1963), and must do so in sworn testimony made available to the manufacturer and to the public.

5) In the failure of the FDA to contest certification of nontoxicity or harmlessness in sworn testimony, the manufacturer is free to place the product in question in interstate commerce.

6) FDA officials up to and including the Commissioner will be guilty of committing a felony if they fail to observe the 90- day deadline. Manufacturers subjected to delays beyond the 90-day deadline are hereby authorized to press both criminal and/or civil charges against such FDA officials as seek to delay introduction of a product into interstate commerce, after the 90-day deadline has passed, without the presentation of sworn testimony establishing that the product is more toxic than aspirin or that it is harmful despite certification of its harmlessness by the Underwriters Laboratory.

7) Once a product is placed into interstate commerce, the FDA is expressly forbidden from seeking an injunction to prohibit such introduction into interstate commerce. Any FDA official will be guilty of a felony who seeks such an injunction, or seeks in any way to delay the introduction into interstate commerce of a product certified as nontoxic or harmless in the manner above stipulated.

8) From the effective date of this Act, FDA’s authorization to press criminal charges is restricted to products which are toxic, and FDA is prohibited from pressing criminal charges in any regulatory action when products have been certified as nontoxic and harmless in the manner stipulated. Similarly, the FDA is prohibited from confiscating such products as have been certified as nontoxic and harmless.

9) Employees of the FDA, upon their departure from the FDA, are hereby prohibited for ten years from working in any capacity, either as an employee, consultant, or member of a board, for any company subject to regulation by the FDA.

10) Employees of the Federal Trade Commission (FTC) upon their departure from the FTC, are hereby prohibited for ten years from working in any capacity, either as an employee, consultant, or member of a board, for any company subject to regulation by the FDA.

11) The General Accounting Office (GAO) will carry out a study to determine which and how many FDA employees will be rendered superfluous when the FDA is prohibited from regulating nontoxic substances or harmless devices, after the effective date of this law.

12) When the said GAO study is completed, and when the said number of FDA employees to be rendered superfluous is determined, the FDA is then required to put such superfluous employees to work in "post-marketing surveillance". Postmarketing surveillance is the regulatory inspection of substances already approved by the FDA as prescription drugs. Since such drugs, used in the indicated way, have become one of the top causes of death in the U.S., extensive and intensive additional regulatory supervision is needed. FDA was created to make sure that drugs are safe and needs to return to that focus. The American public has no need of protection against products certified as nontoxic or harmless, which have no place under FDA jurisdiction. Relieved of unnecessary regulation over products certified as nontoxic and harmless, the FDA will then be free to return to its basic duty of protecting the American public from toxic drugs, a duty at which it has failed in recent years. Thus FDA regulatory efforts will be focused and concentrated upon products which can do harm rather than dissipated in examination of products which cannot do harm.

Source:
“Politics in Healing”
Daniel Haley
Sept. 2000
Potomac Valley Press

ACCESS TO MEDICAL TREATMENT ACT (AMTA)

During the 2000 session of Congress, this bill was S-1955 in the Senate and HR-2635 in the House of Representatives. During the 2001 session, the bill will have to be reintroduced, so the numbers will change, and perhaps some provisions, but the name and objectives will remain the same.

What is the Access to Medical Treatment Act?

This is a Health Freedom bill. It will create a federal statutory right for consumers to use unapproved drugs and devices, so long as they follow the safety provisions in the bill. It will free practitioners from the fear of censorship, harassment, or worse for using unconventional therapies. It will guarantee your right to access the medical treatments of your choice, without the need of FDA approval. It will give Americans the ability to use therapies that are available to millions of people worldwide, and eliminate the need for Americans to go to Canada, Germany, Mexico, and elsewhere for therapies that are still considered illegal here in the U.S.

Would this bill open the door to dangerous quackery?

NO. Consumer protections are an essential element of the bill. The AMTA was conceived as a patients’ rights bill, to ensure that all Americans have access to the full range of therapies. Practitioners need to be protected from those who want to censure them or even to eliminate unconventional treatments. This is a freedom of choice bill. It gives Americans access to therapies that are being used safely and effectively in other countries, but which are not available here because FDA has not approved them. Freedom of choice is one of the bedrock principles upon which our nation rests. Asserting the right to use alternative treatments, provided that patients are not misled or misinformed, extends freedom of choice to the realm of medicine. This legislation stems from the conviction that an individual, suffering from a disease for which conventional medicine offers limited or no hope, should not be denied access to a nonconventional treatment if there is reason to believe that it might be beneficial. It also recognizes that not everyone is willing to suffer the side effects of conventional therapies when less toxic remedies are available.

What specific safeguards are there for consumers?

The legislation requires that unapproved treatments must be administered by licensed or otherwise authorized health care providers. It does not permit them to exceed their normal scope of practice. The products may not be advertised or promoted, which would prevent unscrupulous individuals from profiting from the sale of unapproved drugs. In addition, practitioners would be prohibited from charging more than an amount necessary to recover their costs. This restraint, coupled with other consumer protections in the bill, is meant to limit the use of unapproved drugs and devices to practitioners and manufacturers who have the best interests of the patients in mind.

Don’t we need the FDA to approve these substances to ensure that they are safe and effective?

The FDA is not in the business of regulating the practice of medicine, yet it has tried to insert itself into the process through its hammerlock on the dissemination of scientific information, its attempts to classify natural substances as drugs, and its delay in approving therapies that have been used successfully in other countries for decades. If Americans are to achieve the best health care in the world, the present system of regulation must be altered.

Why don’t companies simply get their therapies approved by the FDA?

The present system doesn’t work for therapies that are unpatentable (because they incorporate natural substances). It costs upwards of $300 million and takes a decade or more to obtain FDA approval of drugs today. Without patent protection, a manufacturer could not recoup that expense. In addition, many foreign companies are unwilling to commit that time and expense for products already approved for use overseas.