S-355-119
Held at the desk.
Sponsored by Cory Booker (D-NJ)
What it does
This bill would require the FDA to publish an interim final rule within one year, updating its regulations to replace references to "animal" tests with the broader term "nonclinical tests" across more than 20 sections of federal drug approval regulations. It would also add a statutory definition of "nonclinical test" to key regulatory sections. The bill implements language already enacted in the Consolidated Appropriations Act of 2023, which first authorized non-animal testing methods for drug development. It also makes a minor technical correction to fix a duplicate subsection label in existing law.
Who benefits
Pharmaceutical and biotechnology companies that develop or use non-animal testing technologies (e.g., organ-on-a-chip, computer modeling, cell-based assays), as they would gain clearer regulatory standing for these methods. Animal welfare organizations and advocates who oppose animal use in research. Researchers and startups specializing in alternative testing technologies, who would gain a more level regulatory footing. Patients who may benefit if alternative methods accelerate or improve drug development pipelines. Academic institutions developing computational and in vitro testing tools.
Who is hurt
Contract research organizations (CROs) and laboratory animal suppliers whose business models depend on animal-based preclinical testing, who may face reduced demand over time. Researchers whose expertise is specifically in animal-based toxicology and pharmacology. Animal breeders and vivarium operators. Potentially, drug safety advocates who argue that animal testing provides irreplaceable whole-organism safety data that alternative methods cannot yet fully replicate.
Supporters argue
Supporters argue that the 2023 Consolidated Appropriations Act already authorized non-animal testing methods but that outdated regulatory language still effectively requires animal studies, creating a gap between statute and regulation that this bill closes. They contend that validated alternatives — such as organ-on-a-chip systems and computational toxicology — can produce equivalent or superior safety data for certain drug classes, and that aligning FDA regulations with current law removes an unnecessary barrier to innovation and reduces costs and timelines in drug development.
Opponents argue
Opponents argue that updating regulatory language to treat non-animal methods as equivalent to animal studies may outpace the scientific validation of those methods, potentially weakening the safety evidence base for new drugs before alternatives are fully proven. They contend that animal studies capture whole-organism, multi-system interactions — including immune responses and organ crosstalk — that current in vitro and computational models cannot reliably replicate, and that moving too quickly risks approving drugs with safety profiles that are inadequately characterized.
Constitutional context
This bill directs an executive agency (HHS/FDA) to issue a specific rule within a set timeframe, which falls squarely within Congress's authority under the Commerce Clause (Art. I, §8, cl. 3) and the Necessary and Proper Clause (Art. I, §8, cl. 18) to regulate drug commerce and direct agency action. No significant constitutional tension is apparent, though post-Loper Bright (2024), courts would independently review whether any resulting FDA rule stays within the statutory authority Congress has granted.
Checks and balances
Congress directs HHS/FDA to issue the rule; the executive branch (FDA) retains discretion over technical implementation details; federal courts could review the rule's scope under the post-Loper Bright standard of independent statutory interpretation.
Historical precedent
The FDA Modernization Act 2.0, enacted as part of the Consolidated Appropriations Act of 2023, first removed the statutory requirement that animal testing be used in drug development, directly preceding this bill's regulatory implementation effort.