Shandra Eisenga Human Cell and Tissue Product Safety Act
Shandra Eisenga Human Cell and Tissue Product Safety Act
Plain Language Summary
# Shandra Eisenga Human Cell and Tissue Product Safety Act (HR 1082) **What the bill does:** This legislation strengthens safety oversight of human cell and tissue products—materials like skin grafts, bone, cartilage, and other biological products used in medical treatments. It establishes financial penalties (fines) for companies or organizations that violate FDA rules about donor screening and manufacturing practices. The bill also requires the FDA to hold educational workshops with healthcare professionals and industry stakeholders, create a public comment system, and report back to Congress with recommendations on how these products should be regulated. **Who it affects:** The bill impacts manufacturers and processors of human cell and tissue products, healthcare providers who use these products, tissue banks, and ultimately patients who receive these treatments.
The FDA gains new enforcement tools and responsibilities. **Current status:** The bill has passed the House of Representatives and is now under consideration in the Senate. It was named after Shandra Eisenga, whose case highlighted safety concerns with tissue product handling and distribution.
CRS Official Summary
Shandra Eisenga Human Cell and Tissue Product Safety ActThis bill establishes civil penalties for violations of regulations governing the donation and handling of human cell and tissue products. It also requires the Food and Drug Administration (FDA) to report on the regulation of these products and to provide related information to stakeholders. (Human cell and tissue products are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.)Specifically, the bill establishes civil penalties for violations of the FDA’s regulations on donor eligibility and current good tissue practice for manufacturing and distributing human cell and tissue products.Also, the bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion on 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 report to Congress with recommendations. The bill also requires the FDA to support the development of educational materials for health care professionals regarding organ, tissue, and eye donations and related topics.Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group (a working group within the FDA) and best practices for obtaining a recommendation from them about human cell and tissue products. Also, annually for three years, the FDA must publish on its website information on inquiries submitted to the Tissue Reference Group and FDA registrations and inspections regarding human cell and tissue manufacturers.
Latest Action
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.