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Dear Editor: The FDA Modernization Act, a bill to allow the use of 21st century test methods for drugs before they go to market, is at a critical juncture and I urge Sens. Ron Johnson and Tammy Baldwin and our Wisconsin U.S. representatives to cosponsor this important legislation. Doing so will lower drug costs, speed delivery of drugs to patients and reduce the number of animals used in testing.  It’s a win-win for people, animals and industry. 

Data show that animal tests are unreliable predictors of the human response to drugs. Between 90% and 95% of drugs found safe in nonclinical tests fail during human clinical trials due to toxicities not predicted by traditional animal tests or lack of efficacy. Yet the FDA requires animal testing even if there are superior non-animal methods. 

Human-relevant cell-based assays, organs-on-a-chip, human-on-a-chip (microphysiological systems) and computer modeling have been developed to more accurately predict human response to new drugs. 

It’s time to tweak the Food, Drug and Cosmetics Act to provide drug sponsors more options for testing the safety and efficacy of drugs to improve clinical-trial attrition rates, cut time to market in half and substantially reduce research and development costs that could cut drug prices. 

Paul Collins

Animal Wellness Action

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