Shandra Eisenga Human Cell and Tissue Product Safety Act
Key claim: The Shandra Eisenga Human Cell and Tissue Product Safety Act creates civil penalties for violations of FDA donor-eligibility and good-tissue-practice rules and requires the FDA to expand education, stakeholder input, congressional reporting, and public transparency on human cell and tissue products.
Abstract
(HR1082 · 119th Congress) Shandra Eisenga Human Cell and Tissue Product Safety Act This 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 (2025-06-24): Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Why this matters
For patients receiving tissue-based products (grafts, reproductive tissue, cellular therapies) and for the tissue banks and clinics that supply them, this bill would raise the enforcement stakes for existing FDA donor-screening and good-tissue-practice rules by adding civil monetary penalties on top of current inspection and recall authorities. The new workshop, docket, and reporting duties would also give providers and the public more visibility into how FDA oversees HCT/Ps, potentially shaping future guidance and compliance expectations. The bill is at introduction stage in the Senate HELP Committee and has not yet changed any coverage or payment rules.