Bill · S. 4885· Senate(119-S-4885)
Shandra Eisenga Human Cell and Tissue Product Safety Act
- Introduced
- 6/24/2026
- Last activity
- 6/24/2026 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Gary Peters
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
The Shandra Eisenga Human Cell and Tissue Product Safety Act requires the Secretary of Health and Human Services to lead a national education campaign. This campaign aims to increase awareness among the public and health care providers regarding the risks and benefits of human cell and tissue product transplants. The bill also mandates the development of educational materials covering organ, tissue, and eye donation. Additionally, it establishes strict civil penalties for those who violate specific regulations regarding these products. The legislation seeks to streamline regulatory oversight by requiring the publication of specific data on the FDA website. Finally, it directs the Secretary to develop recommendations for regulating these products while considering scientific developments and public health.
Yes
Does this make what the government does easier for the public to see?+5
The bill requires the FDA to publish specific data regarding inspections, registration, and response times on its website.
Does this make health care easier to get in general?+4
The bill seeks to increase awareness of organ, tissue, and eye donation to improve availability and access to these products.
Does this put more money into medical research?+3
The bill promotes scientific advancement and the generation of scientific data for cellular therapies through workshops and regulatory updates.
The opposite
Would business owners be better off under this?-4
The establishment of high civil penalties for regulatory violations creates a significant financial risk for business owners in this sector.
Does this make it easier to run a small business?-3
The bill introduces significant civil penalties of up to $20,000 per violation and $10,000,000 in aggregate which could burden smaller establishments.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Awareness and Education: The Secretary will support educational materials for health care professionals regarding organ, tissue, and eye donation, including methods for approaching families and information on donor screening tests (Section 3).
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Improved Public Information: The FDA will publish data on the website regarding the number of registered establishments, the number of inspections conducted, and the response times of the Tissue Reference Group (Section 5(a)(2)).
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Stakeholder Support: The Secretary will provide information to various stakeholders, including patients, and conduct workshops to support regulatory predictability and scientific advancement (Section 5(a)(3)).
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Modernizing Regulation: The bill includes processes to modernize the regulation of human cell and tissue products by considering scientific developments and protecting public health (Section 5(c) and 5(d)).
Potential Negative Impacts for People
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Significant Financial Penalties: Any person who violates certain requirements for human cell or tissue products can be held liable for civil penalties of up to $20,000 per violation, an additional $20,000 for each day a violation continues, and an amount equal to the retail value of the products (Section 4).
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Large Cap on Fines: Total civil penalties for violations adjudicated in a single proceeding may reach up to $10,000,000 (Section 4).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Improves Healthcare Access+4Increases Research Funding+3
- Governance And Ideology
- Improves Government Transparency+5
- Demographic And Interest Groups
- Good For Business Owners-4
- Economy And Finance
- Improves Small Business Support-3
- 6/24/2026
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
2 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Roger MarshallRepublican · Kansas