Statement on the NIH Statement regarding the Timeline and Scope of Animal Testing Reductions

ACNP Statement on the NIH Statement regarding the Timeline and Scope of Animal Testing Reductions

The American College of Neuropsychopharmacology (ACNP) expresses concerns regarding the timeline and scope of plans to reduce reliance on animal-only research projects that were described at the recent FDA-NIH Workshop on July 7, 2025. While we appreciate the regulatory agencies’ commitment to advancing alternative methodologies and the NIH’s clarification that future Notices of Funding Opportunity (NOFOs) will prioritize human-based research technologies complemented by animal models rather than eliminating animal research entirely, we believe that careful implementation will be critical to maintaining scientific rigor in neuropsychopharmacology research.

The development of treatments for devastating psychiatric and neurological disorders including depression, anxiety, schizophrenia, Alzheimer’s disease, and addiction to opioids and other misused substances requires a complex understanding of brain function that cannot yet be replicated through alternative methodologies alone.

While New Approach Methodologies (NAMs), including AI-based computational models and organoid testing, show promise, they remain insufficient for comprehensive neuropsychopharmacological research when used in isolation. Indeed, ACNP launched a new journal focusing on digital- and computational-based approaches for psychiatry and neuroscience research (NPP-Digital Psychiatry and Neuroscience) in 2023 to expedite dissemination of cutting-edge research in these important and evolving domains. The NIH’s initiative to prioritize human-based research technologies, while advancing the field toward more translational approaches, must be implemented thoughtfully to ensure continued progress in understanding brain disorders that affect millions of Americans.

Moving too rapidly toward human-based methodologies without fully validated complementary approaches poses potential risks to patient safety. Inadequate preclinical testing could lead to clinical trials with insufficient safety data, potentially exposing vulnerable patient populations to unforeseen as well as unnecessary risks including but not limited to illness, disability, or death.