Former FDA Senior Official Describes His Fight to Modernize Drug Development, Replace Animal Testing

Study in a Sentence: David Gortler, MD, former senior advisor to the Food and Drug Administration commissioner, describes his fight to modernize the methods used in drug testing to improve outcomes for humans while reducing and replacing animal testing.

Healthy for Humans: Science and technology have advanced beyond the traditional animal-based approaches that have been used in FDA submissions since the 1960s, but policies and practice have not kept pace. Dr. Gortler sought investment in parallel studies of organs-on-chips (OOCs), which are engineered tools that use human cells to reconstitute human organ level function and which are used in testing pharmaceutical products.

Redefining Research: While many comparative studies already show that OOCs are more predictive than animal-based approaches, Dr. Gortler sought to test whether OOCs would speed nonclinical drug development by more accurately predicting safety and efficacy in humans. The proposal was refused, and Dr. Gortler now calls upon the FDA to keep pace with scientific progress and to embrace new technology while setting positive examples against animal cruelty.