Sec. 2. Findings
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The Congress finds as follows: The mission of the National Institutes of Health
(NIH)is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Much of NIH’s research is carried out on animals. However, the precise number of animals used in research in the United States is unknown. Estimates range between 17 million and 100 million animals used annually. Such imprecise numbers make it impossible to effectively track and reduce the numbers of animals used, as mandated by the NIH policies to ensure the smallest possible number of animals are used. There is widespread agreement among scientists and regulatory agencies that animal models are poor predictors of the human response, with over 90 percent of new candidate drugs never making it to market. More than 30 percent of promising medications have failed in human clinical trials because they are found to be toxic despite promising pre-clinical studies in animal models. An additional 65 percent of candidate drugs that pass animal trials fail due to lack of efficacy. Despite the ever-increasing growth in animal procedures, there is no corresponding increase in the number of human medicines making it to the clinic. Dramatically rising costs and extremely high failure rates in drug development have led many to re-evaluate the value of animal studies. Effective alternatives to animals are available and growing. Cutting-edge technology has forged new frontiers in biology and medicine that have produced human-relevant models, including organoid cell cultures, organs-on-chips, genomics, induced pluripotent adult stem cells, 3D modeling with human cells, high throughput technology, molecular imaging, computer models, in silico trials, digital imaging, artificial intelligence, and other innovative methods—all of which have launched a technological revolution in biomedical research. Despite these cutting-edge, human-relevant methods, a preponderance of NIH research is carried out on animals. A 2019 news release from NIH indicates that 70 percent of NIH grant applications relate to studies using mice. The American public has expressed concern about subjecting animals to the pain of experimentation. This concern grows as alternatives to research on animals become available. Under the system of oversight established by the National Institutes of Health Revitalization Act of 1993 ( Public Law 103–43 ), NIH is supposed to outline a plan for reducing the use of animals in research. Section 404C(a)(1) of the Public Health Service Act ( 42 U.S.C. 283e(a)(1) ), as added by section 205 of the National Institutes of Health Revitalization Act of 1993, calls for NIH to conduct or support research into … methods of biomedical research and experimentation that do not require the use of animals and methods of such research and experimentation that reduce the number of animals used in such research . A dedicated center that provides resources, funding, and training to encourage researchers to utilize humane, cost-effective, and scientifically suitable non-animal methods is needed to fulfill the intent of the National Institutes of Health Revitalization Act of 1993 ( Public Law 103–43 ).
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- Pub. L. 103-43
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