The end of animal testing?

New legislation in the United States means it is no longer necessary to test medicines on animals before human trials can commence as part of the Food and Drug Administration (FDA) approval process.

Signed by President Biden, it is hoped that the new rules could signal a major shift away from animal use after more than 80 years of drug safety regulation.

Previously, for a drug to be approved in the United States, the FDA typically required toxicity tests on one rodent species and one non-rodent species, such as a monkey or dog.

This process used tens of thousands of animals annually but, with more than nine in 10 subsequent human clinical trials failing, activists have argued that animal experiments are unnecessary and a waste of time, money, and lives.

Animal rights groups have welcomed the news and described it as a win not only for animals but also for patients and the healthcare industry.

Groups such as Animal Wellness Action have argued that, in preparing for human trial stages, the FDA should rely on computer modelling, ‘organ chips’, and other non-animal methods that have been developed over the past 10 to 15 years.

This new legislation paves the way for such approaches and now allows the FDA to promote a drug or biologic to human trials after either animal or non-animal tests.

While a major step forward, pro-research groups argue that the change will be slow and will not transform the drug approval process overnight.

Americans for Medical Progress, which advocates for animal research, states that non-animal technologies are still in their infancy and claims they won’t be able to replace animal models for many years to come.

Despite this, animal alternatives are increasing.

Recently, Emulate unveiled its organ chip technology that utilizes living cells and tissues from organs such as the brain, liver, lung, and kidney to evaluate the toxicity and effectiveness of experimental drugs on the human body.

Other animal alternatives include organoids - hollow, 3D clusters of cells that are derived from stem cells and mimic specific tissues. They have shown promise in predicting liver and cardiac toxicities. Proponents also tout the potential of digital artificial neural networks for rapidly identifying the toxic effects of drugs.

It should be noted that while this new legislation allows the agency to clear a drug for human trials without animal testing, it doesn’t require that it do so.

However, it is hoped it will open new paths of thinking around the alternatives available and their efficacy.

Related: Healthcare 2023 – the trends to watch