Shandra Eisenga Human Cell and Tissue Product Safety Act
Impact
If enacted, HB 7188 will significantly impact the regulations surrounding human cell and tissue products. By requiring the Secretary to initiate educational programs and update existing donor eligibility guidelines, the bill hopes to reduce health risks and improve the overall safety of transplant procedures. This legislation will also enable ongoing communication between stakeholders in the tissue transplant community, including healthcare providers and industry experts, thereby promoting regulatory predictability and ensuring that safety practices remain aligned with scientific developments.
Summary
House Bill 7188, titled the 'Shandra Eisenga Human Cell and Tissue Product Safety Act', aims to enhance public and healthcare provider awareness regarding the risks and benefits associated with human cell and tissue product transplants. The bill mandates the Secretary of Health and Human Services to conduct a nationwide education campaign and to develop informational materials that focus on organ, tissue, and eye donation, as well as the availability of donor screening tests. This effort seeks to improve understanding among both professionals and families impacted by transplant decisions.
Sentiment
The sentiment towards HB 7188 appears generally positive among health advocates and transplant organizations who recognize the importance of informed decision-making in advancing public health policies. Ensuring that both providers and the public are educated about the benefits and risks associated with transplants aligns with broader goals of enhancing healthcare outcomes and patient safety. However, there may be apprehensions regarding the adequacy of funding and resources needed to execute these educational initiatives effectively.
Contention
There were discussions surrounding the potential challenges of implementation and the administrative burden placed upon the Secretary of Health and Human Services. Some critics may argue that the bill requires a significant investment in public outreach that could distract from other pressing healthcare priorities. Additionally, determining the effectiveness of the awareness campaign and ensuring compliance among healthcare providers will be key factors that will need monitoring to assess the long-term impact of the legislation.
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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