Animal testing is outmoded because, unlike human biology-based test methods, animals are unreliable predictors of human response, delaying treatments and cures to patients and driving up drug costs.
Just more than a year ago, Congress passed the FDA Modernization Act 2.0, and President Biden signed the bill into law. It was, without question, the most important policy in the nation’s history addressing animal testing. The bill eliminated an 84-year-old animal-testing mandate for every new drug in development, whether a drug for cancer, pain, Alzheimer’s, or any other affliction of the human body.
This new law promised a reboot of our national policies on drug development, sparing the lives of millions of animals a year, saving drug developers billions because they could now use more reliable and less expensive screening methods, and delivering better lifesaving and life-enhancing treatments and cures for tens of millions of patients in need.
Now, however, the U.S. Food and Drug Administration, which is charged with implementing the law, is failing to revise regulations that still bind drug developers to use primates, beagles, and other animal tests. In holding onto these archaic regulations, the FDA is defying Congress and the will of the people.
Harvard’s Wyss Institute announced the development of a human “body-on-a-chip” platform that enables in-vitro prediction of drug behaviors in humans.
Emulate leverages human biology + technology to ignite a new era in human health.
Quris’ AI Clinical Prediction Platform better predicts which drug candidates will safely work in humans, avoiding tremendous costs of failed clinical trials.
AxoSim empowers advancements in human neuroscience and accelerates the drug development process through their human-relevant drug discovery platform
The Business Case
The Center noted that FDA, the pharmaceutical sector, and academic institutions involved in research all have pledged to abide by the “3 Rs” when it comes to animal testing — reduction, refinement, and replacement of animal tests. These key stakeholders all must act with urgency to embrace a better, safer, more reliable safety regimen.
There should be a vigorous and methodical approach to eliminating the use of animals in favor of alternative methods over time. The running scandal is the enormous failure rate in drug development, the lack of cures for so many diseases, and the high prices for drugs that keep them out of reach for so many Americans.
Now, Congress must compel the FDA to update its regulations so drug-developers can take advantage of modern scientific methods and end the horrors suffered by animals in their lab.
We are supporting the FDA Modernization Act 3.0. The new legislation requires the FDA to publish a final rule to implement the FDA Modernization Act 2.0 and establish clear guidelines for non-animal test methods that can better predict drug safety and efficacy, and speed the time to market for new treatments and cures.
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Header photo credit:
Beagle: Jo-Anne McArthur / Animal Equality / We Animals Media, Capuchin monkey: Jo-Anne McArthur / NEAVS / We Animals Media