S. 4885: Shandra Eisenga Human Cell and Tissue Product Safety Act

This bill would direct the Department of Health and Human Services, mainly through the Food and Drug Administration (FDA), to do several things related to human cell and tissue products, such as donated tissues used in transplants and certain cellular therapies.

Public education and awareness

The bill would require HHS to support a national education campaign aimed at both health care professionals and other relevant professionals. The campaign would provide educational materials about:

• organ, tissue, and eye donation;
• evidence-based ways to talk with patients and families about donation;
• the availability of donor screening tests; and
• other issues related to donation.

New civil penalties for violations

The bill would add financial penalties for people or organizations that violate certain FDA requirements governing human cell and tissue products regulated under section 361 of the Public Health Service Act. A violator could be fined up to:

• $20,000 for each violation;
• $20,000 for each day a violation continues after written notice from the Secretary; and
• an amount equal to the retail value of the human cell and tissue products involved.

The total penalty in a single proceeding could not exceed $10 million.

FDA information-sharing and oversight

The bill would require the FDA to publish more information on its website about human cell and tissue products, including:

• educational materials about the FDA’s Tissue Reference Group;
• best practices for getting timely and accurate recommendations from that group;
• the number of tissue establishments that registered with FDA since January 1, 2019;
• the number of FDA inspections of tissue establishments since January 1, 2019, including a comparison with inspections of blood establishments;
• the number and type of inquiries to the Tissue Reference Group in the prior year; and
• the average response time for those inquiries.

Stakeholder education and workshops

The bill would require FDA to provide information and hold workshops or similar educational sessions for stakeholders such as industry, tissue establishments, academic medical centers, research groups, and patients. The goal would be to improve regulatory predictability and support scientific progress.

Updates to existing FDA policy work

The bill would revise a prior FDA reform provision to focus workshop best practices on generating scientific data for certain human cell-, tissue-, and cellular-based medical products, including stem cell and other cellular therapies.

Public comment process and report to Congress

Within 60 days of enactment, HHS would have to open a public docket for written comments on how to improve the regulation of human cell and tissue products, including issues such as minimal manipulation and homologous use. By September 30, 2026, HHS would have to report to Congress on the workshop and public comments and recommend regulatory changes, taking into account regulatory burden, scientific developments, access to products, and public health protection.

Relevant Companies

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