Kidney Cancer Association Supports 5 "Pillars of Safety" for FDA Reform
CEO Bill Bro endorses remarks of Patient Advocate Foundation CEO Nancy Davenport-Ennis before U. S. Senate Committee
(PRWEB) April 8, 2005
The Kidney Cancer Association (KCA) endorsed the recent remarks of Ms. Nancy Davenport-Ennis, CEO of the National Patient Advocate Foundation, Washington, D. C., before the U. S. Senate Committee on Health, Education, Labor and Pensions. KCA president Bill Bro agreed with Ms. Ennis’ characterization that there 5 key “Pillars of Safety” critical to reforms at the United States Food and Drug Administration (FDA):
1. Safety and Efficacy must continue to be the foundational elements of the FDA regulatory process. Safety cannot exist in a vacuum apart from efficacy.
2. Mechanisms to enhance existing structures and processes for post market safety monitoring and adverse event reporting must be explored.
3. Efforts to bring even greater efficiency and scientific expertise to the FDAÂ’s review and monitoring processes must continue; such efforts must be done in a manner that empowers the agency to keep pace with the rapid advancements now occurring in areas such as genomics, proteomics, and nanotechnology.
4. FDA must continue to work with industry, patient groups, physicians, hospitals, academia, and other government agencies to enhance the critical path.
5. The FDA must be sufficiently resourced in order to insure more effective pursuit of its existing mandates. Additional resources are even more essential if FDA is to successfully implement a comprehensive suite of reforms.
Bro said his organization strongly supports such increased federal funding as is necessary to assure that FDA is staffed to meet demands placed on the agency by Congress.
“We are concerned that funding for the agency is currently insufficient to meet the ever-increasing burdens placed upon it.” He added, “If this agency is to remain recognized as the so-called ‘Gold Standard’ globally for the approval of life-saving treatments, our society can ill-afford to deny it adequate funding.”
The complete text of Ms. Davenport-EnnisÂ’ remarks is available online: http://help. senate. gov/testimony/t201_tes. html (http://help. senate. gov/testimony/t201_tes. html).
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