Technical corrections only. The text of H.R. 1082 in v4 is identical to v3, with the only changes being updates to the legislative status information indicating its referral to the Senate. No substantive policy changes were made between these versions.
Shandra Eisenga Human Cell and Tissue Product Safety Act
- Sponsor
- Rep. Moolenaar, John R. [R-MI-2]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jun 24, 2025
Bottom line
The bill aims to enhance safety and transparency in human cell and tissue product transplants through public education, stricter enforcement, and regulatory modernization efforts at the FDA.
What it actually does
This bill, named the Shandra Eisenga Human Cell and Tissue Product Safety Act, mandates the Secretary of Health and Human Services to launch an education campaign on human cell and tissue product transplants. It also establishes civil penalties for violations of FDA regulations concerning these products and directs the FDA to streamline regulatory oversight by publishing information, conducting workshops, and developing recommendations for modernizing regulations, particularly regarding 'minimal manipulation' and 'homologous use' definitions.
Proponents argue
Supporters argue that this bill is crucial for protecting public health by increasing awareness among healthcare professionals and the public about the risks and benefits of human cell and tissue products. They contend that establishing clear civil penalties will deter non-compliance with FDA regulations, while streamlining regulatory processes will foster innovation and provide greater clarity for industry stakeholders, ultimately improving patient access to safe and effective therapies.
Opponents contend
Critics might argue that while the intent is good, the new civil penalties could disproportionately burden smaller tissue establishments, potentially stifling innovation or reducing the availability of certain products. Some may also express concern that the push for 'streamlining' regulations, particularly around 'minimal manipulation' and 'homologous use,' could inadvertently weaken safety standards if not carefully implemented, potentially exposing patients to unproven or risky treatments.
The bill is concise and can be read quickly, allowing sufficient time for an informed reader to grasp its core provisions and implications.
Section 3
Human Cell and Tissue Products Transplant Public Awareness Campaign
This section requires the Secretary of Health and Human Services (HHS) to support the creation and distribution of educational materials. These materials are intended to inform healthcare professionals and other relevant experts about various aspects of organ, tissue, and eye donation, including effective methods for discussing donation with patients and their families, the availability of donor screening tests, and other important considerations related to the donation process.
Supporters argue
Proponents argue that an informed healthcare community is vital for ensuring safe and ethical donation practices. This campaign will empower professionals with evidence-based information, leading to better patient care and more effective communication regarding donation, ultimately increasing the availability of life-saving tissues and organs.
Critics contend
No specific opposition is typically raised against public awareness campaigns for organ and tissue donation, as they are generally seen as beneficial for public health. Potential concerns, if any, might relate to the cost-effectiveness of the campaign or the specific content and messaging, but not the underlying goal.
Tradeoffs
The primary tension is ensuring the educational materials are comprehensive and balanced, covering both benefits and potential risks, without inadvertently creating undue alarm or discouraging legitimate donations. Resource allocation for the campaign also presents a tradeoff against other public health initiatives.
Section 4
Civil Penalties for Violations of Human Cell and Tissue Product Requirements
This section amends the Public Health Service Act to introduce civil penalties for individuals or entities that violate specific FDA regulations (Subparts C or D of 21 CFR 1271) concerning human cell and tissue products. Violators can face a penalty of $20,000 per violation, with an additional $20,000 for each day a violation continues after written notice from the Secretary. Furthermore, an amount equal to the retail value of the products involved in the violation can be added, with a total cap of $10,000,000 for all violations adjudicated in a single proceeding.
Section 5
Streamlining Regulatory Oversight of Human Cell and Tissue Products
This section directs the FDA to undertake several initiatives to streamline regulatory oversight. It requires the FDA to publish educational materials and best practices for interacting with the Tissue Reference Group (TRG) and to annually report statistics on registered establishments, inspections, TRG inquiries, and response times. It also mandates the FDA to provide information and conduct workshops for stakeholders on regulation. Furthermore, it amends existing law to broaden the scope of scientific data generation for cell- and tissue-based products, establishes a public docket for comments on regulatory modernization (including 'minimal manipulation' and 'homologous use'), and requires a report to Congress by September 30, 2026, with recommendations for regulatory updates.
The bill defines 'human cell and tissue product' by referencing 'human cells, tissues, or cellular or tissue-based products' in section 1271.3(d) of title 21, Code of Federal Regulations (or successor regulations). It also specifically mentions 'minimal manipulation' and 'homologous use' as defined in section 1271.3 of title 21, Code of Federal Regulations, as key terms for regulatory modernization.
Section 2(1), Section 4(d)(3), Section 5(c)(2)
Why it matters:This is standard legislative practice for brevity and to ensure consistency with existing legal frameworks. It avoids reprinting lengthy definitions and ensures the bill's scope aligns precisely with established regulatory categories.
Case for: Referencing existing CFR definitions ensures legal precision and avoids creating conflicting definitions. It grounds the bill's scope in established regulatory science and practice, providing clarity for those already familiar with the field.
Case against: While legally precise, relying on external regulatory definitions makes the bill less accessible to the general public. Understanding the full implications requires consulting external documents, which can be a barrier to informed public discourse.
Estimated impact: These definitions are foundational to the entire bill, determining which products are subject to the new education campaign, civil penalties, and regulatory streamlining efforts. Their interpretation directly impacts the scope of FDA's authority and industry compliance.
This subsection amends Section 3205 of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) by striking 'best practices' and all that follows through 'other cellular therapies' and inserting 'best practices on generating scientific data necessary to further facilitate the development of certain human cell-, tissue-, and cellular-based medical products (and the latest scientific information about such products), namely, stem cell and other cellular therapies'.
Section 5(b)
Why it matters:This is standard legislative practice for amending existing statutes. It's a precise way to update or clarify previous legislative intent without reprinting the entire amended section.
Case for: Proponents would argue that this amendment clarifies and broadens the FDA's mandate to provide guidance on scientific data generation for a wider range of advanced cell and tissue therapies, including stem cells. This supports innovation and helps developers navigate regulatory pathways more effectively.
Case against: No specific opposition is typically raised against clarifying or broadening scientific guidance, as it generally benefits both regulators and industry. However, some might argue that such an amendment could subtly shift the FDA's focus or resource allocation, potentially impacting other areas of oversight.
Estimated impact: This amendment expands the scope of FDA's guidance and scientific information dissemination regarding advanced cell and tissue therapies, potentially accelerating development and improving regulatory predictability for these products.