FDA Modernization Act Passes U.S. Senate!
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 FDA Modernization Act 2.0 does exactly that, and we’ve been promoting the policy with our allies in the U.S. Senate and in the U.S. House of Representatives. In 2021, Democrats and Republicans came together to introduce the FDA Modernization Act, H.R. 2565 and S. 2952, to reform our drug approval process and eliminate the animal-testing mandate.
With a bi-partisan vote of 392 to 28, the House passed the FDA Modernization Act as a rider to a larger package of FDA-related reforms, strengthening the chance of enactment this summer for a measure that would eliminate a statutory animal testing mandate for new drug development. The Senate Health, Education, Labor and Pensions Committee will soon hold a “markup” hearing on parallel legislation, which also includes the FDA Modernization Act as a rider.
While we still have work to do as the House and Senate work to reconcile differences in the two FDA legislative packages, we are on the path to see the adoption of a major national new policy to reduce animal testing and unleash the use of alternative test methods in our national efforts to test drugs formulated to cure or palliate disease.
(read more here)
Hero image credit:
Beagle: Jo-Anne McArthur / Animal Equality / We Animals Media, Capuchin monkey: Jo-Anne McArthur / NEAVS / We Animals Media