The current FDA law, which relies exclusively on animal tests to determine if they are safe and effective for humans, has a 95% failure rate in human clinical trials, and sacrifice countless animals, including mice, rats, dogs, and non-human primates.
GLOBE NEWSWIRE: Animal Wellness Action, the Center for a Humane Economy, the Michelson Center for Public Policy, and other affiliated organizations applauded U.S. Representatives for introducing the FDA Modernization Act, H.R. 2565, to lift requirements for [BUT NOT BANNING] animal testing for any new drug development and to enable FDA to require the most effective testing methods, regardless of whether animals are used… The use of animals in new drug development represents a major category of animal testing in the United States, including the widespread use of dogs and primates…
The existing drug development paradigm, established by statute in 1938 under the Federal Food, Drug, and Cosmetics Act (FFDCA) relies on animal tests to determine if they are safe and effective for humans have a 95 percent failure rate in human clinical trials… The modifications to the FFDCA will provide drug sponsors more options for testing the safety and efficacy of drugs in order to improve clinical trial attrition rates, cut time to market in half, and substantially reduce R & D costs which could cut drug prices fivefold…
“This reform would allow the use of the nonclinical test methods most likely to predict how a drug will react in humans, including state of the art nonclinical models based on human biology,” said Gerry R. Boss, M.D., board member of the Center for a Humane Economy and a long-time researcher in drug development… “The FDA Modernization Act promotes animal welfare without compromising scientific research,” said Rep. Elaine Luria, D-Va. “There’s no reason we can’t leverage technology to adopt more compassionate standards for testing consumer drugs and other products. This bipartisan solution is a win-win for animal welfare advocates and science”…
“There has been exciting progress in using human-relevant cell-based assays, organs-on-chips, microphysiological systems, and sophisticated computer modeling to more accurately predict human response to drugs. Unfortunately, the FFDCA does not officially acknowledge these modern nonclinical tools. This amendment will go a long way to not only to reduce the use of animals but also to promote application of the newer technologies that will lead to safer and more effective drugs in the future,” said Dr. Paul Watkins, Director of the Institute for Drug Safety Sciences at the University of North Carolina, Chapel Hill…
The global race for a COVID-19 vaccine reminded the world about the need for urgent action. Data show that it typically takes 10 years and an investment of an average of $2 billion and up to $4 billion for a new drug, slowing delivery of palliatives and cures for patient groups, driving up drug costs, and sacrificing countless animals, including mice, rats, dogs, and non-human primates. SOURCE…
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