Shandra Eisenga Human Cell and Tissue Product Safety Act

This legislation requires the Secretary of Health and Human Services to implement a national, evidence-based education campaign. This campaign aims to increase awareness among the public and healthcare providers regarding the potential risks and benefits associated with human cell and tissue product transplants, as well as best practices for organ, tissue, and eye donation, including donor screening tests. The bill also establishes significant civil penalties for individuals or entities that violate federal regulations pertaining to human cell and tissue products. These penalties can reach up to $20,000 per violation, with additional daily fines for continuing infractions, and an amount equal to the retail value of the products involved, capped at $10,000,000 per proceeding. Furthermore, the legislation mandates the Food and Drug Administration to enhance regulatory oversight and transparency . This includes publishing educational materials and best practices for interacting with the Tissue Reference Group on its public website. The FDA must also annually release data on registered establishments, inspections, and Tissue Reference Group inquiries and response times for four years. To streamline regulatory processes, the bill directs the FDA to provide information and conduct workshops for various stakeholders, fostering regulatory predictability and scientific advancement. It also requires the establishment of a public docket to gather comments on modernizing the regulation of human cell and tissue products, specifically addressing concepts like minimal manipulation and homologous use. Finally, the Secretary must report to Congress with recommendations for regulatory updates, considering scientific developments, access, and public health protection.