FDA Modernization Act 2.0: FDA no longer requires all drugs to be tested on animals before human trials
Animal testing has been a regulatory requirement since 1938 to determine the safety and efficacy of drugs before they enter clinical trials. Despite the fact that animal models have uncovered many disease mechanisms, physiological and genetic differences between animals and humans often result in failures during clinical trials, with significant consequences. Between 2007 and 2010, 66% of Phase III failures were due to lack of efficacy and 21% due to drug toxicity, highlighting the need for improved preclinical evaluation and predictive data for clinical candidates 1.
However, recent data shows that this gap in predictive accuracy continues to persist. A review of 221 animal experiments found that only 50% had results that agreed with later human studies 2, and animal testing continues to fail in predicting toxicity in nearly half of drugs in the pipeline between Phase I trials and early post-market withdrawals 3.
