Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1082

Introduced
2/6/25  
Refer
2/6/25  

Caption

Shandra Eisenga Human Cell and Tissue Product Safety Act

Impact

The legislation is expected to significantly impact state and national regulations related to organ and tissue donation by enhancing the knowledge base for healthcare professionals and the public. It aims to address prevalent issues in donor screening and tissue viability, thereby potentially increasing donor rates and improving transplant outcomes. Furthermore, the bill introduces stricter regulatory compliance measures, establishing civil penalties of up to $10 million for violations of guidelines pertaining to human cell and tissue products, which may influence how organizations manage compliance moving forward.

Summary

House Bill 1082, titled the Shandra Eisenga Human Cell and Tissue Product Safety Act, aims to enhance awareness regarding the risks and benefits associated with human cell and tissue products transplants. The bill mandates that the Secretary of Health and Human Services initiate a cohesive, evidence-based education campaign directed at both the public and health care providers. This initiative includes the development of educational materials on organ donation, procedure protocols, and patient communication—focusing on informed decision-making and modern best practices.

Contention

While the bill has garnered support for its objectives of public health improvement and education, concerns may arise regarding the enforcement of penalties and the implications for healthcare providers. Critics might argue that the financial burden of compliance could lead to less participation from smaller practices or organizations. The establishment of a public docket for feedback and revisions to regulations indicates an acknowledgment of stakeholder input, which may help mitigate these concerns. Overall, the balance between robust education and regulatory oversight will be a focal point in discussions surrounding the bill's implementation.

Congress_id

119-HR-1082

Policy_area

Health

Introduced_date

2025-02-06

Companion Bills

US HB340

Related The HCT/P Modernization Act of 2025This bill requires the Food and Drug Administration (FDA) to provide information to stakeholders and report on the regulation of human cell and tissue products, also referred to as human cells, tissues, or cellular or tissue-based products (HCT/Ps), which are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.The bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion with them on advancing the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and submit to Congress a report with recommendations on regulating these products. Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group and best practices for obtaining a recommendation about products from them. Also, annually for three years, the FDA must publish on its website information on the inquiries submitted and average response times for the Tissue Reference Group, as well as the number of human cell and tissue manufacturers that have registered with the FDA and the number of inspections the FDA has conducted with respect to these manufacturers since 2019. (The Tissue Reference Group is a working group within the FDA that receives product-specific questions from, and provides recommendations for, stakeholders on the regulation of human cell and tissue products under the FDA’s rules.) 

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