House Passes the Shandra Eisenga Human Cell and Tissue Product Safety Act

The US House of Representatives passed H.R. 7188, the Shandra Eisenga Human Cell and Tissue Product Safety Act, by voice vote this week. Sponsored by Reps. John Moolenaar (R-MI) and Debbie Dingell (D-MI), the legislation was combined with H.R. 8251, the HCT/P Modernization Act, and advanced unanimously (40-0) by the House Energy & Commerce Committee earlier this year. The bill now moves to the Senate, where it must pass by the end of the week to avoid reintroduction next year.

H.R. 7188 introduces critical measures to enhance the safety and oversight of human cell and tissue products, including:

• Public Awareness Campaign: The Department of Health and Human Services (HHS) will be required to conduct a public awareness campaign focused on organ, tissue, and eye donation, including evidence-based methods of approaching patients and their families, and the availability of any donor screening tests. 
• FDA Guidance Updates: The Food and Drug Administration (FDA) will be required to review and update its donor eligibility guidance and any other relevant guidance documents to reduce the risk of transmission of mycobacterium tuberculosis and sepsis by human cells, tissues, and cellular and tissue-based products (HCT/Ps).
• Civil Penalties and Transparency: The FDA would have new authority to issue civil penalties for violations of regulatory standards under subparts C and D of 21 CFR 1271 regarding human cell or tissue products. The agency will also be required to publish information on the Tissue Reference Group (TRG), including the number and type of inquiries to the TRG in the preceding year and the average response time for submissions to the TRG. 
• Modernization Feedback: The FDA will be required to establish a public docket to receive written comments on modernizing the regulation of human cell and tissue products, including as it relates to assessing minimal manipulation and homologous use. Additionally, HHS will submit a report to Congress by September 30, 2026, with recommendations to improve the regulation of human cell and tissue products. The report will address regulatory burden, scientific advancements, access to HCT/Ps, and public health protections.

AATB supported H.R. 7188 upon its introduction and remains committed to working with lawmakers to ensure the safety, availability, and advancement of life-transformative tissue product transplants.