HEARTS Act of 2025

If passed, the NIH will redirect funding toward alternative method development and institutions will incur compliance costs for data collection and reporting. Historical precedent: the 1993 NIH Revitalization Act mandated animal use reduction planning, but the bill's sponsors argue oversight gaps prevented implementation—this bill attempts to enforce that vision through concrete incentive structures and a dedicated center. The European Union's REACH and ECHA regulations (established 2007) successfully reduced animal testing through mandatory alternative assessment and reporting; by 2023, EU animal testing declined significantly, though timelines for chemical safety testing extended initially. Pharmaceutical industry adoption of organoid and microphysiological systems has accelerated since 2015, with major companies investing heavily in alternatives. The bill's bi-annual reporting requirement creates transparency that could accelerate institutional innovation toward alternatives, or expose institutions with high animal use to public scrutiny and potential funding pressure. The U.S. EPA and FDA have begun accepting non-animal data for certain toxicology endpoints since 2019, reducing regulatory barriers to alternatives adoption. No CBO cost estimate is provided in the bill text.