H.R.2821 - FDA Modernization Act 3.0 (119th Congress)
Summary
H.R. 2821, the FDA Modernization Act 3.0, directs the Secretary of Health and Human Services, through the FDA Commissioner, to finalize rules regarding nonclinical testing methods. This bill aims to implement changes from the Consolidated Appropriations Act of 2023, specifically those related to replacing references to "animal" tests with "nonclinical" tests in FDA regulations. The bill mandates the publication of an interim final rule within one year of enactment to amend relevant sections of Title 21 of the Code of Federal Regulations and to incorporate the definition of "nonclinical test".
Expected Effects
The primary effect of this bill will be to formally update FDA regulations to reflect the shift towards non-animal testing methods. This includes updating terminology and definitions within the Code of Federal Regulations. The immediate effectiveness of the interim final rule will expedite the implementation of these changes.
Potential Benefits
- Promotes innovation in drug development by encouraging the use of advanced nonclinical testing methods.
- Reduces reliance on animal testing, potentially leading to more ethical and humane research practices.
- Streamlines the regulatory process by clarifying definitions and updating outdated terminology.
- Could lead to faster and more efficient drug approval processes.
- May reduce the cost of drug development by utilizing potentially cheaper non-animal testing methods.
Potential Disadvantages
- Potential for initial uncertainty and confusion as the industry adapts to the new terminology and regulations.
- Risk that nonclinical tests may not always accurately predict human responses, potentially leading to safety concerns.
- Possible need for additional resources and training for FDA staff and industry personnel to effectively implement the new regulations.
- Concerns from some stakeholders who believe animal testing is still necessary for certain types of drug development.
- The interim final rule becoming immediately effective bypasses typical notice and comment periods, potentially limiting public input.
Constitutional Alignment
This bill appears to align with the general welfare clause of the Constitution, as it aims to improve public health and safety through modernizing drug testing regulations. Specifically, the bill falls under the purview of Congress's power to regulate interstate commerce, as it pertains to the regulation of drugs and medical devices that are often produced and distributed across state lines (Article I, Section 8, Clause 3). The bill does not appear to infringe upon any specific constitutional rights or limitations.
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).