H.R. 2821, FDA Modernization Act 3.0
Pass the FDA Modernization Act 3.0.
Occurrences
Evidence
FDA said it would begin reducing animal-testing requirements for monoclonal antibodies and other drugs, starting immediately for IND applications and using AI, cell lines, organoids, and other NAMs.
The roadmap says FDA will reduce animal testing in preclinical safety studies with validated NAMs and cites Congress's 2022 FDA Modernization Act 2.0 as the recent legislative baseline.
Assessments
The promise is specifically to pass the FDA Modernization Act 3.0. The evidence shows later FDA administrative progress in reducing animal-testing requirements, but those actions explicitly build on the 2022 FDA Modernization Act 2.0 and do not show that a 3.0 act was enacted. There is also no evidence here that Ken Calvert sponsored, wrote, or materially advanced a 3.0 measure to final passage. Because the candidate remains in federal office and the record provided does not establish either enactment or a definitive failed end-state, the best judgment is unresolved rather than delivered or partial.