Till recently, there hasn’t been a clear way for nonanimal methods to gain the FDA’s stamp of approval, a concept for which the Physicians Committee has advocated for years. This changed when the FDA launched its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program in December 2020. ISTAND provides a pathway for companies and the FDA to work together to qualify nonanimal methods. Importantly, methods qualified under ISTAND will be communicated to sponsors via agency guidance indicating that the method can be used for its qualified purpose without the usual need for companies to do extensive validation work to use a new method. In the program’s first year, multiple companies have contacted the agency seeking to begin the process.
Despite all the inertia pushing for business as usual, revolutionary advances have been made in human-specific approaches that can reduce and replace animal use. When policies and funding shift to favor human-specific nonanimal approaches over animal experiments, the American public can expect safer and more effective drugs to be developed faster and at a lower cost—financially and morally.
INQUIRIM VITAE 