FDA Modernization Act 2.0 Passes U.S. Senate!
Now We Need Your Help to Pass the Bill in the U.S. House of Representatives. ACT NOW!
Groundbreaking Legislation has the Potential to Spare Animals, Bring Safer and Better Treatments to Patients, and Drive Down Drug Prices
The U.S. Senate passed the FDA Modernization Act 2.0, S.5002, without dissent, taking a major step toward enacting a policy that could dramatically reduce testing on dogs, primates, and other animals in the years ahead. The bill, introduced by Senators Rand Paul, R-Ky. and Cory Booker, D-N.J., with 10 other cosponsors, will eliminate a federal mandate for animal testing for new drugs. (Senator Paul’s speech below)
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.
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.
(read more here)
Hero image credit:
Beagle: Jo-Anne McArthur / Animal Equality / We Animals Media, Capuchin monkey: Jo-Anne McArthur / NEAVS / We Animals Media