UPDATE! The U.S. Senate passed the FDA Modernization Act 2.0 (S.5002) in late September without a single dissenting voice. Now we need the U.S. House to bring it to a vote before the end of the year, but we cannot do it without your help. Please urge your U.S. House Representative to contact Chairman Frank Pallone to bring (S.5002) to the House floor for a vote before it ends its work for the year, sending the measure to the President. Doing so will improve the safety and effectiveness of biologics and biosimilar drugs for all Americans.
The FDA Modernization Act 2.0 would eliminate a 1938(!) mandate requiring drug developers to conduct animal tests and instead allow them to use the non-animal, human-relevant methods.
Millions of animals, including dogs, cats, rabbits, mice, rats, and pigs, are used to develop drugs each year. By removing the FDA’s mandate for animal testing, drug developers can spare the suffering of animals.
Fortunately, non-animal testing methods are available and include cell-based assays, organ chips, microphysiological systems, sophisticated computer modeling, and other human biology-based test methods. Approximately, 90% of all new drugs fail in human clinical studies after years of development and billions of dollars are spent and the unknown loss of animal lives.
Not only are animal lives wasted but incredible amounts of time and money, are wasted too. It takes at least 10 years and $1 billion to bring a new drug to market. Due to the reliance on animal testing, there is an overall failure rate in drug development of over 96%, including a 90% failure rate during clinical development in humans. That high failure rate inflates the price of the few successful drugs that actually reach the market. Those inflated costs are passed on to consumer through health insurance premiums.
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