This week, the U.S. Food and Drug Administration (FDA) launched Innovative Science and Technology Approaches for New Drugs (ISTAND), a pilot program that will help reduce and replace animal testing as part of drug development. The Physicians Committee for Responsible Medicine has worked toward this goal for several years by meeting with the FDA and Congress and providing expert input, hosting Congressional briefings, and leading drug development stakeholders in advocating for a pathway for the approval of nonanimal, human-biology based drug testing methods.
The FDA launched ISTAND to expand its ability to qualify drug development tools that are outside the scope of the FDA’s existing Drug Development Tools Qualification Program (DDT). The DDT program excluded the vast majority of nonanimal in vitro and computational approaches. Before ISTAND, if a drug developer wanted to use a human biology-based approach, it would only be reviewed and accepted on a case-by-case basis. The