The FDA Modernization Act 3.0 updates regulations to replace "animal tests" with "nonclinical tests" and incorporates the definition of "nonclinical test" to reflect advancements in testing methods for drugs and biological products.
Earl "Buddy" Carter
Representative
GA-1
The FDA Modernization Act 3.0 updates regulations for drug testing by replacing the term "animal tests" with "nonclinical tests" in the Code of Federal Regulations to reflect advancements in testing methods. It also incorporates the definition of "nonclinical test" as defined in the Federal Food, Drug, and Cosmetic Act. Additionally, the bill corrects a subsection designation within the Federal Food, Drug, and Cosmetic Act to ensure legal clarity.
FDA Rulebook Update: 'Nonclinical Tests' to Replace 'Animal Tests' in Drug Safety Regs Within One Year
This part of the FDA Modernization Act 3.0 directs the Food and Drug Administration (FDA) to update its regulations within one year. The core change? Officially swapping out the term "animal tests" for the broader "nonclinical tests" when describing the safety studies needed before testing drugs in humans. This isn't totally new ground – it's about making the rulebook match a change Congress already made to the main drug law (the Federal Food, Drug, and Cosmetic Act) back in late 2022 via the Consolidated Appropriations Act, 2023.
More Than Just Mice: Updating the FDA's Playbook
So, what counts as a "nonclinical test"? The law defines it pretty broadly: it can be tests run in test tubes (in vitro), computer simulations (in silico), or studies using other non-human methods – which can still include animals, but crucially, doesn't have to. Think sophisticated computer modeling, lab-grown human cells or tissues (sometimes called 'organoids' or 'organs-on-chips'), or other methods that don't involve live animals. This update requires the FDA to comb through specific sections of its regulations (Title 21 of the Code of Federal Regulations, covering things like clinical trial applications and new drug approvals) and make sure the language reflects this wider range of acceptable tests. It's basically aligning the detailed instructions with the overarching law, acknowledging that modern science offers more ways to assess drug safety before human trials.
Dotting I's and Crossing T's: The Regulatory Details
The bill sets a deadline: the FDA has one year from the Act's passage to issue what's called an "interim final rule" making these language changes. This rule will take effect immediately. The legislation also includes a bit of technical housekeeping, fixing a numbering issue where two different parts of the Food, Drug, and Cosmetic Act accidentally got labeled as subsection (z). This bill re-labels one of them as (aa) to clear up the confusion. While much of this section focuses on administrative updates and aligning regulations with existing law, it formally cements the regulatory space for potentially faster, more diverse, and ethically varied approaches to preclinical drug testing.