Revolution in Drug Development in the US: The End of Animal Testing?

The US Food and Drug Administration (FDA) has updated its regulations to allow, in appropriate cases, the use of alternative methods to animal testing, such as human cells, organs-on-chips, and computer models. The move aims to clarify that animal testing is not the only way to obtain safety information, but does not eliminate it. The change is expected to also affect pharmaceutical and research companies in Israel.

The US Food and Drug Administration (FDA) has published a significant regulatory update, allowing pharmaceutical companies to rely on alternative methods to animal testing in early development stages. The change aims to clarify that animal testing is not the only way to obtain safety information for regulatory decisions. Among the alternatives presented by the FDA: tests on human cells, 'organ-on-a-chip' systems that simulate organs like the liver, lungs, or heart, and computer models for predicting drug distribution in the body and toxic risks. The FDA emphasizes that this is not a ban on animal testing, and that such tests will still be required when no suitable alternative exists or when the validation level of the alternative method is insufficient. The evidence threshold required for approval of human trials will not change. Alongside the change, the FDA published an initial database of 25 examples of the use of the new methods. The move may also impact pharmaceutical companies, biotechnology companies, and research institutions in Israel seeking to begin clinical trials in the US. However, the decision on each product will be made based on the potential risks and the quality of evidence provided by the alternative. The change was published as a direct final rule, but the FDA allows the public and professional stakeholders to submit comments, and if substantial objections are received, the agency may withdraw the rule.