Shandra Eisenga Human Cell and Tissue Product Safety Act
Impact
This legislation is poised to impact existing state laws related to health and safety, particularly regarding human cell and tissue products. By establishing a formal avenue for education through the Secretary of Health and Human Services, the bill promotes increased scrutiny and oversight of the safety standards applicable to these medical products. It encourages healthcare providers to consider updated guidelines on transplant procedures and could lead to improved patient outcomes through better informed medical practices.
Summary
SB3733, known as the 'Shandra Eisenga Human Cell and Tissue Product Safety Act', aims to enhance public and healthcare provider awareness about the risks and benefits associated with human cell and tissue product transplants. The bill mandates the Secretary of Health and Human Services to engage in a nationwide, evidence-based educational initiative to inform stakeholders about these products. This campaign is expected to utilize various multimedia platforms to ensure broad outreach, emphasizing the potential health risks, including infectious diseases, related to human cell and tissue products.
Contention
While the bill aims to promote safety and awareness, it may spark debate regarding the extent of regulation in the healthcare sector. Critics may argue that mandatory education campaigns could place additional burdens on healthcare providers and establishments involved in tissue transplants. Additionally, the effectiveness and allocation of resources towards such campaigns could invite scrutiny, prompting discussions on whether they adequately address the concerns they intend to resolve. The potential financial implications for compliance in terms of civil penalties for violations further adds complexity to its acceptance.
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.)
A resolution expressing support for the designation of June 19, 2024, as "World Sickle Cell Awareness Day" in order to increase public awareness across the United States and global community about sickle cell disease and the continued need for empirical research, early detection screenings, novel effective treatments leading to a cure, and preventative care programs with respect to complications from sickle cell anemia and conditions relating to sickle cell disease.
Expressing support for the designation of June 19, 2024, as "World Sickle Cell Awareness Day" in order to increase public awareness across the United States and global community about sickle cell disease and the continued need for empirical research, early detection screenings, novel effective treatments leading to a cure, and preventative care programs with respect to complications from sickle cell anemia and conditions relating to sickle cell disease.