FDA Modernization Act Ushers In Era Of “Cruelty-Free Drugs” With President’s Signature​

Congress Eliminates 1930s Animal-Testing Requirement

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“This is the biggest policy development in Congressional history in the quest to replace animal testing with morally and scientifically superior non-animal methods,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “Lawmakers were persuaded by our campaign to scrap mandatory animal testing in favor of 21st-century testing methods grounded on human biology.”

Why Animal Testing is Outmoded

It's bad science

The FDA's 80+ year-old drug development scheme requiring animal testing for the safety and efficacy of new drugs for humans hasn’t kept pace with 21st Century advances in science.

Why?

The process is slow, too regimented, and predictably imprecise. Animal tests are required, even though they are often poor predictors of what happens in humans and often don’t get the disease.

We should be ...

using human relevant, non-animal test methods, including organs on chips combined into Microphysiological Systems could cut drug development time in half, and reduce R&D costs fivefold. *

It's time to ...

test new drugs in test systems based on human biology, not animal biology. It typically takes drugmakers 10 years to bring a vaccine to market.  Animal testing drags out the timeline as scientist are required to examine the drug’s effect on multiple generations of multiple species of animals.

The results ...

are often hardly worth the wait. 95% of drugs that pass animal tests for safety and efficacy fail in human trials. In laboratory animal testing for new drugs, we have normalized and excused this massive failure rate of 5% efficacy

  • Source: Marx, U., Andersson, T. B., Bahinski, A. et al. (2016). Biology-inspired microphysiological system approach to solve the prediction dilemma and substance testing. ALTEX 33, 272-321.doi:10.14573/altex.1603161

Read about the FDA Modernization Act 2.0

Hero image credit:
Beagle: Jo-Anne McArthur / Animal Equality / We Animals Media, Capuchin monkey: Jo-Anne McArthur / NEAVS / We Animals Media