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

Congress Eliminates 1930s Animal-Testing Requirement

“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 21^st 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

FDA Modernization Act 2.0

The federal government drug development model is broken. Relying solely on animal tests to determine the safety and efficacy of new drugs hasn’t brought the desired results. The reality is, 95 percent of drugs fail in human clinical trials after animal tests purportedly show safety and efficacy.

In a move to revolutionize modern science in drug development, the U.S. Senate passed the FDA Modernization Act 2.0 (S.5002) in late September without a single dissenting voice. Now the U.S. House of Representatives must act before the Congress ends its work for the year, sending the measure to the President and ushering in a new era of humane drug development to deliver treatments and cures to patients more quickly and at lower costs and sparing millions of animals in the process.
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Hero image credit:
Beagle: Jo-Anne McArthur / Animal Equality / We Animals Media, Capuchin monkey: Jo-Anne McArthur / NEAVS / We Animals Media

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