H.R. 2821: FDA Modernization Act 3.0

The FDA Modernization Act 3.0 (H.R. 2821) is a proposed law introduced in April 2025 by Representative Earl L. 'Buddy' Carter. Its main goal is to update existing regulations to allow drug developers to use alternative testing methods instead of traditional animal testing when assessing the safety and effectiveness of new drugs and medical devices. The bill requires the Secretary of Health and Human Services to publish an interim final rule within one year of enactment. This rule would update specific sections of the Code of Federal Regulations to replace references to 'animal' tests with 'nonclinical' tests and define 'nonclinical test' in various parts of the drug approval process.

Supporters of the FDA Modernization Act 3.0 argue that it represents a significant step forward in modernizing drug development by reducing reliance on animal testing. They believe that incorporating alternative nonclinical testing methods can lead to more efficient and ethical drug development processes. Proponents also highlight that the bill aligns with scientific advancements and public sentiment favoring the reduction of animal testing.

Critics of the FDA Modernization Act 3.0 express concerns about the reliability and validation of alternative nonclinical testing methods. They worry that moving away from traditional animal testing could compromise the safety and efficacy assessments of new drugs and medical devices. Some also point out that the bill may face challenges in implementation, as regulatory agencies and the pharmaceutical industry would need to adapt to new testing standards and ensure that alternative methods are adequately validated.

The FDA Modernization Act 3.0, sponsored by Earl Carter, presents a significant potential conflict of interest due to the substantial financial contributions from the Health Professionals sector, totaling $120 million. This industry directly overlaps with the subject matter of the bill, which aims to modernize FDA regulations that could impact healthcare practices and pharmaceutical approvals. Given that all of the sponsor's top donations come from individuals within this sector, there is a clear financial incentive for the sponsor to advocate for policies that may favor these donors. Voters should be aware that such financial ties could influence legislative outcomes that affect public health and safety.

These industries are both affected by this bill and among the sponsor's top donors.

Organizations that lobbied on issues related to this bill's policy area.

Source: Senate Lobbying Disclosure Act (LDA) filings, 2026

Top industries funding Earl Carter, ranked by total contributions.

Source: OpenSecrets.org (Center for Responsive Politics)