Congress is currently considering The FDA Modernization Act, which would end mandatory animal testing for new drugs. As technology has progressed, animal testingis no longer necessary to determine whether drugs are safe and effective before they go to market. It is for this reason that I urge U.S. Sens. Chris Van Hollen and Ben Cardin, and Maryland’s members of the U.S. House of Representatives, to cosponsor this pressing legislation. Doing so will modernize a more-than-80-year-old drug development scheme, lower drug costs, expedite delivery of drugs to patients and reduce the number of animals harmed.
Data show that animal tests are unreliable predictors of the human response to drugs (”Johns Hopkins University can continue barn owl testing after permit battle with PETA,” July 14). Many 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 Food and Drug Administration requires animal testing even if there are superior non-animal methods.
Since animal testing was made mandatory decades ago, new technologies have emerged that are more accurate predictors of human response and are more efficient, including human-relevant cell-based assays, organs-on-a-chip, human-on-a-chip (microphysiological systems) and computer modeling.
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 five-fold. It’s a win-win for people, animals and industry
— Scott A. Schulman, Silver Spring
The writer is Maryland state director for Animal Wellness Action.
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