EXECUTIVE SUMMARY
Signed into law December 29, 2022, the FDA Modernization Act 2.0 represents the most significant change to drug testing requirements since the 1938 Federal Food, Drug, and Cosmetic Act. This landmark legislation removes the 84-year-old mandate requiring animal testing for investigational new drug (IND) applications, enabling pharmaceutical companies to use New Approach Methodologies (NAMs) including organ-on-chip systems, organoids, and computational models.
KEY PROVISIONS
- Section 3209: Amends Federal Food, Drug, and Cosmetic Act Section 505(i)
- Removes "animal" requirement: Replaces with "nonclinical tests or studies"
- NAMs explicitly included: Cell-based assays, organ chips, microphysiological systems, computer models
- Sponsor discretion: Companies choose appropriate testing methods
- FDA acceptance: Agency must accept qualified alternative methods
LEGISLATIVE HISTORY
- Sponsors: Sen. Rand Paul (R-KY) and Sen. Cory Booker (D-NJ)
- Bipartisan support: Unanimous Senate passage
- Included in: Consolidated Appropriations Act, 2023
- Public Law: 117-328, Section 3209
- Effective: December 29, 2022
INDUSTRY IMPACT
- Accelerates adoption of human-relevant testing models
- Reduces drug development costs (animal studies: $2-5M per compound)
- Improves predictive accuracy for human drug response
- Opens pathway for organ-on-chip and organoid companies
- Catalyzes investment in NAMs technology sector