To the Editor: Kudos to Collins 



To the Editor: 

Kudos to Sen. Susan Collins for co-sponsoring the FDA Modernization Act of 2021 (H.R. 2565 and S. 2952), legislation to allow the use of 21st century test methods for new drugs before they go to market. 

Data show that animal tests are unreliable predictors of the human response to drugs. Between 90 percent and 95 percent 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 (micro physiological 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 fivefold. 

It’s time to modernize for the benefit of people and animals. 

 

Jennifer Skiff 

Tremont 

 

 

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