Shandra Eisenga Human Cell and Tissue Product Safety Act
- Bill Number
- H.R. 1082
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Passed House
- Latest Action
- 2025-06-24: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-07-10T16:58:20Z
AI-Generated Summary
Purpose
The Shandra Eisenga Human Cell and Tissue Product Safety Act (H.R. 1082) aims to enhance public and health care provider awareness of the risks and benefits associated with transplants of human cell and tissue products (such as skin, corneas, or bone used in medical treatments). It also seeks to improve regulatory oversight, enforcement, and transparency to ensure safety while promoting scientific advancement and access to these products.
Key Provisions
- Definitions (Section 2): Defines key terms, including "human cell and tissue product" (referring to human cells, tissues, or cellular/tissue-based products regulated by the FDA under existing rules), "Secretary" (head of the Department of Health and Human Services, or HHS), and "Tissue Reference Group" (an FDA advisory body on tissue-related issues).
- Public Awareness Campaign (Section 3): Requires the Secretary of HHS to develop and distribute educational materials for health care professionals and others on topics like organ, tissue, and eye donation methods, donor screening tests, and other donation-related issues.
- Civil Penalties (Section 4): Adds new penalties to the Public Health Service Act for violations of FDA regulations on human cell and tissue products (specifically subparts C and D of 21 CFR 1271). Penalties include up to $20,000 per violation, an additional $20,000 per day for ongoing violations after notice, plus the retail value of affected products; the total per proceeding cannot exceed $10,000,000.
- Streamlining Regulatory Oversight (Section 5):
- Requires the FDA to publish educational materials and best practices on its website about the Tissue Reference Group.
- Mandates annual public reports (starting one year after enactment, for four years) on FDA registrations, inspections of tissue establishments (compared to blood establishments), inquiries to the Tissue Reference Group, and response times.
- Directs the FDA to provide information and conduct workshops for stakeholders like industry, tissue banks, academic centers, research groups, and patients to support predictable regulations and innovation.
- Amends the 2022 Food and Drug Omnibus Reform Act to expand guidance on scientific data for developing stem cell and other cellular therapies.
- Establishes a public docket for comments on modernizing regulations, including concepts like "minimal manipulation" (processing that doesn't alter the product's basic characteristics) and "homologous use" (using the product for the same function in the recipient as in the donor).
- Requires a report to Congress by September 30, 2026, summarizing workshops and comments, with recommendations on reducing regulatory burdens, incorporating science, improving access, and protecting public health.
Significant Changes to Existing Law
- Introduces civil monetary penalties for the first time under the specified FDA regulations for human cell and tissue products, which were previously enforced mainly through other means like injunctions or seizures.
- Expands FDA reporting requirements on inspections, registrations, and advisory group activities, providing more transparency than current practices.
- Updates the 2022 Food and Drug Omnibus Reform Act to broaden focus from "best practices" to include generating scientific data and the latest information on stem cell and cellular therapies.
- Creates new mechanisms like a public docket and congressional report to facilitate input on regulatory modernization, which could lead to future rule changes on how products are classified and approved.
Potential Impacts
- Government Agencies: Increases workload for HHS and FDA through education campaigns, website updates, annual reports, workshops, and a congressional report; may enhance enforcement capabilities via penalties but could strain resources for inspections and responses.
- Citizens: Improves awareness among patients and families about donation risks/benefits and screening, potentially leading to safer transplants and better-informed decisions; could increase access to therapies by streamlining regulations and reducing burdens.
- International Relations: No direct impacts mentioned, though enhanced U.S. standards might influence global tissue trade or harmonization efforts with international regulators.
Main Stakeholders Affected
- Health Care Providers and Professionals: Gain access to educational tools on donation and screening, aiding patient interactions.
- Patients and Donors: Benefit from heightened awareness of risks/benefits and potentially safer, more accessible products.
- Tissue Establishments and Industry: Face stricter penalties for violations but also opportunities for regulatory clarity through workshops, reports, and modernization efforts.
- Research Organizations and Academic Centers: Receive support for scientific advancement via guidance, data sharing, and public input opportunities.
- FDA and HHS: Responsible for implementation, including oversight, education, and reporting.
- General Public: Indirectly affected through improved public health protections and donation promotion.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens FDA enforcement by adding financial penalties, which could deter non-compliance and encourage better industry practices; the public docket and report promote transparency and stakeholder involvement, potentially leading to administrative rule-making under the Administrative Procedure Act.
- Constitutional: No apparent challenges; aligns with Congress's authority under the Commerce Clause to regulate public health and interstate medical products.
- Political: Named after an individual (Shandra Eisenga), suggesting it may stem from a specific incident or advocacy; emphasizes balancing safety with innovation, which could appeal across party lines in health policy debates, though it adds regulatory requirements that might face scrutiny over costs or federal overreach.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Moolenaar, John R. [R-MI-2]
Cosponsors (1)
Recent Actions
- 2025-06-24: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2025-06-23: Motion to reconsider laid on the table Agreed to without objection.
- 2025-06-23: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
- 2025-06-23: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
- 2025-06-23: DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.
- 2025-06-23: Considered under suspension of the rules. (consideration: CR H2860-2862)
- 2025-06-23: Mr. Bilirakis moved to suspend the rules and pass the bill.
- 2025-06-12: Placed on the Union Calendar, Calendar No. 127.
- 2025-06-12: Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
- 2025-06-12: Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
- 2025-04-29: Ordered to be Reported by Voice Vote.
- 2025-04-29: Committee Consideration and Mark-up Session Held
- 2025-02-06: Referred to the House Committee on Energy and Commerce.
- 2025-02-06: Introduced in House
- 2025-02-06: Introduced in House
Bill Versions
- Shandra Eisenga Human Cell and Tissue Product Safety Act — issued 2025-06-23 — PDF (10 pages)
- Shandra Eisenga Human Cell and Tissue Product Safety Act — issued 2025-02-06 — PDF (8 pages)
- Shandra Eisenga Human Cell and Tissue Product Safety Act — issued 2025-06-24 — PDF (8 pages)
- Shandra Eisenga Human Cell and Tissue Product Safety Act — issued 2025-06-12 — PDF (10 pages)