FDA Launches Program to Approve Human Biology-Based Methods for Use in Drug Development

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 drug developer would have to pitch the FDA and provide extensive evaluation studies each time they sought to use the approach. 

ISTAND provides a new avenue for both pharmaceutical companies and test developers to work with the FDA to review a tool for regulatory acceptance. Once a method is qualified via ISTAND, any drug developer can confidently use the method for its qualified purpose without the additional case-by-case work.

Elizabeth Baker, JD, pharmaceutical policy program director at the Physicians Committee, co-authored a manuscript with FDA scientists that described the need for this program. Following its publication, the FDA produced a manuscript indicating that the agency was exploring pathways by which new approaches could gain broad acceptance.

“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,” says Elizabeth. “Kudos to FDA for taking this monumental step!”

To speak with Elizabeth Baker, JD please contact Donna Steele at dsteele [at] pcrm.org (dsteele[at]pcrm[dot]org) or 202-527-7342.