Animal testing is no longer needed to obtain FDA approval for human trials

For years, animal testing has been considered the gold standard for preclinical research. However, a recent change in US legislation means that new drugs do not need to be tested in animal models prior to clinical trials.

Animal testing is the only nonclinical method available to researchers for evaluating the effect of drugs on a whole organism. Yet despite the wealth of literature supporting animal research, we still see unforeseen and fatal side effects in human trials. High-profile pharmaceutical incidents, such as the Phen-fen scandal and TGN1412 trial, highlight the impact of species differences on clinical translatability.

New legislation passed in the US means that drugs can proceed to human trials without being tested on animals. The FDA Modernization Act 2.0 (signed at the end of 2022) expands the range of nonclinical models that can be used prior to human studies to include:

• cell-based assays
• computer modeling
• organ chips
• other human/non-human-based systems

Thanks to technological advances these alternative testing methods are becoming increasingly translational and accessable. This change in legislation may encourage researchers to improve their relevance further. You can find out more about the new FDA Modernization Act 2.0 and why some researchers are skeptical about its potential impact on the REPROCELL blog here: "Will the FDA Modernization Act 2.0. increase the use of alternative testing methods?"

Further Materials

BBC Two - The Drug Trial: Emergency at the Hospital - BBC documentary about the TGN1412 trial

FDA no longer needs to require animal tests before human drug trials | Science | AAAS - News release from Science

The 3Rs | NC3Rs - Website for the National Centre for the Replacement, Refinement & Reduction of Animals in Research.