Shandra Eisenga Human Cell and Tissue Product Safety Act
- Bill Number
- S. 4885
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 2
- Status
- Introduced
- Latest Action
- 2026-06-24: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-07-07T04:53:30Z
AI-Generated Summary
Purpose of the Legislation This bill aims to enhance public and health care provider awareness of human cell and tissue product transplants through an evidence-based education effort, strengthen enforcement against regulatory violations, and modernize oversight of these products to balance safety, access, and scientific progress.
Key Provisions Outlined
- Education Campaign: Requires the Secretary of Health and Human Services to develop and share materials with health care professionals on organ, tissue, and eye donation practices, donor screening tests, and related donation topics.
- Civil Penalties: Introduces new fines for violations of FDA rules (21 CFR 1271 Subparts C and D) on human cell and tissue products regulated under Section 361 of the Public Health Service Act, including up to $20,000 per violation (plus daily penalties after notice) and the retail value of affected products, capped at $10 million per proceeding.
- Regulatory Streamlining: Directs the FDA to post educational resources and best practices on its website about the Tissue Reference Group; publish annual data on registrations, inspections, inquiries, and response times; hold stakeholder workshops; create a public comment docket on regulation updates (including minimal manipulation and homologous use); and submit a report to Congress by September 30, 2026, with recommendations on oversight.
- Amendments: Updates a prior law (Food and Drug Omnibus Reform Act of 2022) to focus on scientific data for stem cell and cellular therapies.
Significant Changes to Existing Law Introduced
- Adds a new subsection to Section 368 of the Public Health Service Act (42 U.S.C. 271) establishing civil penalties specifically for human cell and tissue product violations.
- Modifies Section 3205 of the Food and Drug Omnibus Reform Act of 2022 to emphasize scientific data generation for certain medical products.
- Creates new FDA reporting, website publication, and public engagement requirements not previously mandated in statute.
Potential Impacts
- On government agencies: Increases FDA workload for education, inspections, data tracking, workshops, and reporting, while providing tools for better regulatory predictability.
- On citizens: Improves awareness for patients and families considering donations or transplants, potentially affecting access to these products.
- On international relations: Minimal direct effects, though enhanced U.S. regulatory clarity could influence global standards in regenerative medicine.
- Overall: May raise compliance costs for industry but could improve public health protections and support innovation.
Main Stakeholders Affected
- Federal agencies, primarily the Department of Health and Human Services and Food and Drug Administration.
- Human cell and tissue establishments, tissue banks, and industry participants.
- Health care providers, academic health centers, research organizations, and biomedical consortia.
- Patients and the general public seeking information on donations and transplants.
Notable Legal, Constitutional, or Political Implications
- Strengthens administrative enforcement through civil penalties without new criminal provisions, focusing on public health under existing Section 361 authority.
- Promotes transparency via public dockets and reports, potentially reducing regulatory uncertainty in an evolving field.
- Emphasizes evidence-based approaches to minimal manipulation and homologous use determinations, which could shape future FDA guidance while considering scientific developments and access issues.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Recent Actions
- 2026-06-24: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2026-06-24: Introduced in Senate
Bill Versions
- Shandra Eisenga Human Cell and Tissue Product Safety Act — issued 2026-06-24 — PDF (8 pages)