S.355 - FDA Modernization Act 3.0 (119th Congress)
Summary
S.355, the FDA Modernization Act 3.0, mandates the Secretary of Health and Human Services, via the FDA Commissioner, to finalize rules regarding nonclinical testing methods. This bill aims to replace references to "animal" tests with "nonclinical" tests in specific sections of Title 21 of the Code of Federal Regulations. The bill also incorporates the definition of "nonclinical test" into relevant sections of the CFR.
Expected Effects
The immediate effect will be a shift in regulatory language, emphasizing non-animal testing methods. This could lead to increased development and acceptance of alternative testing methodologies. Ultimately, this may reduce reliance on animal testing for drug and cosmetic safety evaluations.
Potential Benefits
- Promotes innovation in testing methodologies by encouraging alternatives to animal testing.
- Potentially reduces the cost and time associated with drug and cosmetic development.
- May lead to more ethical and humane testing practices.
- Could improve the accuracy and relevance of safety testing by utilizing more advanced nonclinical methods.
- Enhances regulatory consistency by updating references in the Code of Federal Regulations.
Potential Disadvantages
- Potential for initial uncertainty or confusion during the transition to new testing methods.
- Possible increased costs for companies investing in new nonclinical testing technologies.
- Risk that nonclinical tests may not fully replicate the complexities of biological systems, potentially leading to unforeseen safety issues.
- May require additional training and expertise for regulatory agencies and industry personnel.
- Could face resistance from groups that prioritize traditional animal testing methods.
Constitutional Alignment
The bill appears to align with the Constitution's broad goals of promoting the general welfare (Preamble). Congress has the power to regulate interstate commerce, which includes the regulation of food, drugs, and cosmetics (Article I, Section 8, Clause 3). The specific regulations outlined in the bill fall under this purview.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).