U.S. Food and Drug Administration (FDA) launches pilot program to help reduce and replace animal testing in 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 drug developer would have to pitch the FDA and provide extensive evaluation studies each time they sought to use the approach.
"ISTAND provides a much-needed avenue for the FDA and industry to integrate new approaches that will improve drug development outcomes for humans without harming animals. Kudos to FDA for taking this monumental step!", said Elizabeth Baker, JD, pharmaceutical policy program director at the Physicians Committee.