FDA updates drug safety testing rules to embrace non-animal methods

The US Food and Drug Administration (FDA) is seeking public comment on its newly published direct final rule, that clarifies its terminology around use of non-animal methods where appropriate for testing drug safety prior to studies in humans.

The rule replaces terms such as ‘animal tests’ and ‘animal studies’ with the terms “nonclinical tests” and ‘nonclinical studies.’ The update also replaces related terms, including ‘preclinical’ and ‘in vitro’.

Overall, the FDA’s rule no longer includes language that could indicate animal testing is the only acceptable method for producing safety information for regulatory decisions in products used in humans. The agency clarified however, that the rule does not eliminate or prohibit animal studies, change standards or add financial or regulatory requirements on drug developers.

The agency’s direct final rule defines ‘nonclinical test’ and ‘nonclinical study’ in line with the Food and Drug Omnibus Reform Act of 2022 (FDORA). This recognises newer, non-animal methods and traditional animal studies as options for providing the evidence required for first-in-human clinical studies.

“[This new rule] gives scientists and drug developers greater flexibility to use the testing approach that best addresses their scientific question”

Kyle Diamantas, Acting FDA Commissioner of Food and Drugs

 

Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, said: “This new rule supports the Trump Administration’s push to explore ways to complement, or where appropriate, replace animal studies with methods that may better predict how medicines will actually affect people.

“It gives scientists and drug developers greater flexibility to use the testing approach that best addresses their scientific question. Our goal is not to replace one rigid approach with another. It is to support rigorous, modern science — including animal studies when they remain appropriate and validated alternatives when they can provide the evidence needed to protect patients.”

Additionally, a new database by the FDA features specific uses of New Approach Methodologies (NAMs).

Earlier this month, the agency appointed four permanent senior leaders as directors of both the FDA’s drug and biologics evaluation centres, as well as its first deputy commissioner for technology and artificial intelligence (AI).