House votes to push FDA past animal testing rules

The FDA Modernization Act 3.0 passed the House, directing the agency to update rules that still reference animal testing.

The US House of Representatives passed the FDA Modernization Act 3.0 this week. The bill would require the FDA to update regulations that still reference animal testing wherever federal law already permits alternative nonclinical methods. It was sponsored by Rep. Buddy Carter, with Rep. Nanette Barragán as lead Democratic co-sponsor.

The bill builds on the 2.0 version, which passed in 2022 and removed the statutory requirement for animal testing before human trials. In 2025 the FDA released a roadmap aiming, within three to five years, to make animal studies the exception rather than the default in preclinical safety and toxicity testing. The NIH has backed the shift with more than $150 million through its Complement-ARIE program and a prior $87 million organoid initiative.

Why it matters for abundance: animal studies are slow and expensive, and they are a major cost bottleneck early in drug development. Validated alternatives — organoids, cell-based assays, computational models — can be faster and cheaper, which over time means more candidate drugs tested and lower development costs feeding into eventual prices.

The caveats are real. The Senate passed a nearly identical bipartisan bill in December, but the two chambers must align before it reaches the president. Experts are split on how much the March draft guidance will change practice, and Vanda Pharmaceuticals criticized it for vague validation requirements. Supporters concede that rewriting regulations will take time. Watch for final passage and how quickly the FDA actually updates its rules.

Source: Fierce Biotech