Shandra Eisenga Human Cell and Tissue Product Safety Act

The Shandra Eisenga Human Cell and Tissue Product Safety Act seeks to improve the safety and public understanding of human cell and tissue products (HCT/Ps). It directs the Secretary of Health and Human Services to conduct a national, evidence-based education campaign. This campaign will inform both the public and healthcare providers about the potential risks and benefits of HCT/P transplants, as well as best practices for organ, tissue, and eye donation. The Act introduces new civil penalties for violations of HCT/P regulations, specifically subparts C or D of section 1271 of title 21, Code of Federal Regulations. Violators could face penalties of up to $20,000 per day for continuing violations, plus an amount equal to the retail value of the products involved, with a total cap of $10,000,000 per proceeding. These penalties aim to strengthen compliance and deter unsafe practices within the HCT/P industry. Furthermore, the legislation mandates the Food and Drug Administration (FDA) to streamline regulatory oversight and increase transparency. The FDA must publish educational materials and best practices for its Tissue Reference Group on its public website. It will also annually publish data on registered HCT/P establishments, inspections conducted, and the number and average response times for inquiries to the Tissue Reference Group, enhancing public access to crucial regulatory information. Finally, the Act requires the Secretary to engage stakeholders through information sharing and workshops to support regulatory predictability and scientific advancement. It also establishes a public docket for comments on modernizing HCT/P regulation and mandates a report to Congress by September 2026 with recommendations for regulatory improvements, considering factors like regulatory burden, scientific developments, and public health protection.