Cancer Cure Coalition Proposes Major Changes ...(fetyregulators keep raising the bar for ...),Health

We at the Cancer Cure Coalition agree with Dr. Miller that "What the FDA needs is competent management, discipline in the ranks, more effective risk- benefit balancing, a commitment to permitting patients to assume more responsibility for the risk of medicines, and the banishment of politics from regulatory decisions and policy."

We think that reform is needed as soon as possible, and we propose the following steps be taken:

1. Substantial additional funding should be given to the FDA to help it fulfill the increase in duties placed upon it by the Congress.

2. The "Food" division should be separated from the "Drug" division. Insuring the safety of food for the United States is an enormous responsibility and would be best performed by an agency dedicated to that purpose.

3. A special study should be made by an independent organization to make sure that the FDA has competent management. Those managers who are incompetent should be replaced. In the "Drug" division, management is needed that will recognize the needs of the patients and that will apply effective risk-benefit balancing.

4. Consideration should be given to using certified non-governmental agencies to perform the oversight of drug testing and the review of new drug applications. This would reduce cost while improving the quality of the review process.

Unless we move for reform now, the FDA will continue to harm the interests of patients, our health industry and the economy of the United States.

Contact:

Charles A. Reinwald, Chairman

Charles Reinwald, Jr., President

Cancer Cure Coalition

561-747-2174

E-mail: cancercurecoal@aol.com

http://www.cancercurecoalition.org

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