H.R. 1082: Shandra Eisenga Human Cell and Tissue Product Safety Act

This bill, known as the Shandra Eisenga Human Cell and Tissue Product Safety Act, aims to enhance the safety and awareness associated with human cell and tissue product transplants. Below are the primary components of the bill:

Public Awareness Campaign

The Secretary of Health and Human Services is tasked with supporting the development and distribution of educational materials. These materials will focus on:

• Organ, tissue, and eye donation, including effective ways to discuss this with patients and their families.
• Tests for screening donors to ensure safety.
• Other relevant aspects related to donation.

Civil Penalties for Violations

The bill introduces civil penalties for entities that violate regulations surrounding human cell and tissue products. Key points include:

• Violators may face penalties of up to $20,000 for each violation.
• If violations continue after the Secretary provides notice, an additional $20,000 per day can be imposed.
• Penalties can reach a maximum of $10 million for all violations in a single adjudication.

Regulatory Oversight Enhancement

The Secretary is required to improve transparency and accessibility regarding human cell and tissue products by:

• Publishing educational materials about the Tissue Reference Group on the FDA's public website.
• Regularly publishing information on the number of registered human cell and tissue establishments and the inspections conducted by the FDA.
• Providing information and conducting workshops for stakeholders involved in the regulation and use of these products.

Scientific and Regulatory Updates

The bill mandates updates to scientific and regulatory practices concerning human cell and tissue products. This includes:

• Providing recommendations for best practices for research and the development of these medical products.
• Establishing a public docket for input regarding the regulation of human cell and tissue products.

Report to Congress

By September 30, 2026, the Secretary must provide a report to Congress summarizing discussions from public workshops on human cell and tissue products and offer recommendations. This report will consider:

• Regulatory burdens.
• Scientific advancements.
• Access to these medical products.
• Public health protection measures.

Definitions

Definitions included in the bill clarify the terminology used, such as what constitutes a "human cell and tissue product," and identifies the relevant authorities, including the Secretary of Health and Human Services and the Tissue Reference Group of the FDA.

Relevant Companies

• ABMD - **ABIOMED, Inc.**: This company specializes in heart pumps and organs, and might be affected by increased regulations regarding the safety of transplantable tissue products.
• ILMN - **Illumina, Inc.**: A significant player in genomics, it may see impacts from donor screening requirements and associated testing methodologies.
• CZIV - **CureVac N.V.**: Their work in mRNA technology for therapeutics could be influenced by new regulations regarding human cell products.