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It’s a critical moment in time. The FDA Modernization Act is a bill that, if passed, will allow the use of 21st century test methods for new drugs before they go to market. Maine Sens. Angus King and Susan Collins have cosponsored this important bill. Our Reps. Chellie Pingree and Jared Golden have not committed yet and I’m asking people to please urge them to support the Act.
The FDA Modernization Act will lower drug costs, speed delivery of drugs to patients, and reduce the number of animals used in science. It’s a win-win for people, animals and industry.
Data shows that animal tests are unreliable predictors of the human response to drugs. Between 90 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. The FDA has not changed its policies in over 80 years.
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 Cosmetic 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 R&D costs five-fold.
Please ask our good Reps. Pingree and Golden to cosponsor the FDA Modernization Act.
Jennifer Skiff
Northern Maine Director
Animal Wellness Action
Tremont
