H.R.1082 - Shandra Eisenga Human Cell and Tissue Product Safety Act (119th Congress)
Summary
H.R.1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act, aims to enhance the safety and awareness surrounding human cell and tissue products. It mandates the Secretary of Health and Human Services to conduct a national education campaign. This campaign will inform both the public and healthcare providers about the potential risks and benefits of human cell and tissue product transplants.
The act also introduces civil penalties for violations of regulations related to these products. It seeks to streamline regulatory oversight by improving information dissemination and updating regulatory practices. Finally, the act requires the Secretary to provide information to relevant stakeholders, conduct workshops, and establish a public docket for comments, culminating in a report to Congress with recommendations.
Expected Effects
The Act will likely increase public and healthcare provider awareness regarding human cell and tissue products. It will also strengthen regulatory oversight and enforcement in this area. This could lead to safer practices and increased confidence in the use of these products.
Increased transparency and stakeholder engagement are also anticipated. The civil penalties may deter violations, promoting compliance with existing regulations.
Potential Benefits
- Increased public awareness of the risks and benefits of human cell and tissue products.
- Enhanced safety through stricter enforcement of regulations.
- Streamlined regulatory oversight, promoting efficiency and predictability.
- Improved information dissemination to stakeholders, including healthcare professionals and patients.
- Opportunities for public input through the establishment of a public docket.
Potential Disadvantages
- Potential for increased regulatory burden on tissue establishments.
- The cost of implementing the public awareness campaign and regulatory updates may strain resources.
- Civil penalties could disproportionately affect smaller establishments.
- The time required for the Secretary to develop and disseminate educational materials and conduct workshops may delay implementation.
- The act's focus on regulation may inadvertently stifle innovation in the field of human cell and tissue products.
Constitutional Alignment
The Act aligns with the Constitution's general welfare clause (Preamble). It promotes public health and safety through regulation and information dissemination. The Act does not appear to infringe upon any specific constitutional rights or limitations.
Congress's power to regulate interstate commerce (Article I, Section 8) provides a basis for regulating human cell and tissue products, which are often transported across state lines. The Act's provisions for public awareness campaigns and stakeholder engagement do not raise any apparent constitutional concerns.
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).