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DrSimone.com
Protective Health with Scientific Truth

"What is needed is some person, some institution, some inescapable 'force' that captures the imagination of our citizens and demonstrates that cancer and other diseases will be eliminated only when each of us comes to understand that this can only occur as part of a lifelong process of sanity, balance, moderation, and self-respect."

Internist - Medical Oncologist - Tumor Immunologist - Radiation Oncologist - Author - Inventor - Health Advocate
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Introducing Charles B. Simone, M.MS., M.D. 
Cancer's Worst Enemy 
"Charles Simone Phenomenon"
by William Pitts 
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The most influential people say...

"Nancy joins me in sending you our best wishes for the success of your vital work."
   Ronald Reagan, President

"Dr. Charles B. Simone, an expert in the field of cancer research and treatment, is an individual for whom I have the highest respect."
    Peter W. Rodino, Jr.
    Chairman, Judiciary

"If everyone would follow Dr. Simone’s Plan, we would make major strides toward putting the cancer doctors out of work."
    Robert A. Good, M.D.,Ph.D.
    Former Director, Memorial
    Sloan Kettering Hospital

"I congratulate Dr. Simone on innovative work."
    Dr. Linus Pauling,
   Two Unshared Nobel Prizes

"This book and program should be in all homes and all schools in the early grades. Congratulations, Dr Simone, you have done a great service for all of us."
    Lendon Smith, M.D.,
   Author, "The Children's Doctor"

"Valuable and timely. Should prove beneficial to the public."
    George E. Stringfellow,
   American Cancer Society

"Excellent work"
    Dr. Denis Burkitt, FRCP

"Thank you for all your work on behalf of alternative therapies."
    Tom Harkin, US Senator

"I agree with you that we need to focus not just on treatment but also on prevention."
    Henry Waxman, US House

"Your work will reduce cancer."
    William Bennett, Former
   Secretary of Education

"Thank you for having the courage to come forward. Your testimony was a powerful indicator of the great need for change in America's system of health care, and the importance of an individual's freedom of choice when treating illness."
    Dan Burton, Chairman
   Committee on Government
   Reform & Oversight


Copyright 2013
Charles B. Simone, M.MS., M.D.
(609) 896-2646

FDA’s REVIEW PROCESS STRUCK DOWN

Princeton, NJ – Charles B. Simone, M.D., a medical oncologist, immunologist and radiation oncologist at the Simone Protective Cancer Institute, continues to be a leader in health care matters and Food and Drug Administration reform. In 1993 he was called upon to write the language that led to the compromise in the US Senate and finally the House ensuring that all Americans have free access to food supplements – the Dietary Supplement, Health and Education Act of 1994 (DSHEA).

Wins Landmark Case Against FDA

Charles B. Simone, M.D. was again called upon to help Emord and Associates win a landmark case against the Food and Drug Administration. On January 15, 1999, the United States Court of Appeals for the D.C. Circuit ruled as invalid the FDA's interpretation of the term "significant scientific agreement" for pre-screening nutrient-disease relationship claims of nutritional supplements - [Pearson v Shalala]. The Court found that the FDA’s interpretation of the term "significant scientific agreement" has been "arbitrary and capricious" and "in violation of the Administrative Procedure Act."

FDA Violates First and Fifth Amendments

The Court also held that FDA's four sub-regulations [21 C.F.R. § 101.71(a), (c), (e); and § 101.79(c)(2)(i)(G)] as invalid and in violation of the First and Fifth Amendments to the United States Constitution. The First, because producers of dietary supplements are assertedly subject to a ‘prior restraint’ on their protected speech the labeling of products. The Fifth, because the agency’s approach is so vague as to deprive the producers of liberty (and property) without due process.

The U S Court of Appeals further stated: "It simply will not do for a government agency to declare - without explanation - that a proposed course of private action is not approved. The agency must articulate a satisfactory explanation for its action. To refuse to define the criteria it is applying is equivalent to simply saying no without explanation. Accordingly, on remand, the FDA must explain what it means by ‘significant scientific agreement’ or, at minimum, what it does not mean."