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CCC Chairman addresses Board of Directors of the Alliance for a Stonger FDAThank you for inviting me to present my proposal for expanding the mission of the Alliance for a Stronger FDA to include seeking reform at the agency. First, let me thank the board for its dedication to increasing the funding of the FDA and to congratulate it for the success it has achieved in getting increased appropriations from the Federal Government. You have put together an important organization in the Alliance by bringing together 180 members that represent a cross section of groups and individuals concerned with the success of the FDA. The Alliance includes non-profit groups, law firms and consulting groups, former FDA commissioners, former Human Health Secretaries, industry groups and companies in the food and medical industries, as well as distinguished individuals. Yet with all our efforts, the FDA is still failing to succeed in its mission. The problems in overseeing food safety seem to be overwhelming the FDA as can be seen, for example, in the current salmonella epidemic and in the manufacturing safety problems overseas. Further, the cost of getting new drugs approved by the FDA has continued to rise. It now costs an average of $1 billion and ten years to get a new drug or new treatment approved. This has delayed, and even prevented, the availability of many promising treatments, resulting in an increase in deaths and greater suffering for many. We know from bitter experience that its not sufficient to raise money for research if products discovered are not approved. The FDA itself has acknowledged that it is failing in its mission. In a November 2007 report entitled FDA Science and Mission at Risk, prepared for the FDA by its own subcommittee on Science and Technology, it acknowledges, and I quote, “The FDA cannot fulfill its mission because:1.2.1) its scientific base has eroded and its scientific organizational structure is weak, 1.2.2) its scientific workforce does not have sufficient capacity and capability, 1.2.3) its information technology (IT) infrastructure is inadequate.” End quote. As Dr. Henry I. Miller of the Hoover Institution, a former high level FDA executive, pointed out in his book To Americas Health / A Proposal to Reform the Food and Drug Administration, additional resources alone are not enough. He states, “The agencys most significant problems are mismanagement and a culture that is excessively risk-averse. Repeatedly accused (unjustly) of not being sufficiently concerned about drug safety, regulators keep raising the bar for approval, especially for innovative, high-tech products.” Dr. Miller believes “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 at the Cancer Cure Coalition agree with Dr. Miller, that additional money for the FDA is not enough and that reform is needed as soon as possible. It is for that reason that we are asking the Alliance to broaden its mission to include reform of the FDA. We suggest that reform should include separating the Food division from the Drug division to allow for better focus on the problems in the Food area. We also suggest that a special study should be made by an independent organization to help place more competent management at the FDA. It is not sufficient to obtain more money for the FDA if they do not have people who will use it properly. We also believe that Dr. Millers suggestion of using certified non-governmental agencies to perform the oversight of drug testing and the review of new drug applications should be adopted. This would reduce cost while improving the quality of the review process. Although my proposal for expanding our Alliances mission has advanced three suggestions, I would expect, if the board were to expand the mission, it would not be limited to those suggestions, but it would use its experience and knowledge in assisting the FDA. We believe that the failures at the FDA are jeopardizing the nations health, have weakened Medicare and have adversely impacted the very economy of the United States. We believe that the goal of the Alliance should not be simply to raise money for the FDA but rather to raise money that will be effectively used by the FDA to achieve its mission.
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This Month
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The
Power of Two Update - How Anne Became Healthy
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