H.R. 7188 (RH) – Shandra Eisenga Human Cell and Tissue Product Safety Act
Summary:
The Shandra Eisenga Human Cell and Tissue Product Safety Act (H.R. 7188) is a bill introduced in the House of Representatives on November 23, 2024, by Representative Debbie Wasserman Schultz (D-FL). The bill aims to enhance the safety of human cell and tissue products used in medical procedures.
Background:
The bill is named after Shandra Eisenga, a young woman who died in 2016 from a fungal infection she contracted from a contaminated umbilical cord blood product she received as part of her cancer treatment. The tragedy highlighted concerns about the safety of human cell and tissue products, which are used in a wide range of medical procedures, including organ transplants, blood transfusions, and stem cell therapies.
Key Provisions:
- Establishes a national registry for human cell and tissue establishments: The bill requires all establishments that manufacture, process, store, or distribute human cell and tissue products to register with the Food and Drug Administration (FDA). This will improve traceability and facilitate investigations in the event of adverse events.
- Requires premarket review of certain products: The bill requires the FDA to review and approve certain types of human cell and tissue products before they can be marketed, based on their risk profile. This includes products that are intended to be implanted or infused into patients.
- Enhances post-market surveillance: The bill strengthens the FDA’s ability to monitor human cell and tissue products after they have been marketed. It requires manufacturers to report adverse events and establishes a system for tracking and investigating these events.
- Provides funding for research: The bill authorizes funding for research to improve the safety and quality of human cell and tissue products. This includes research on testing methods, manufacturing processes, and risk assessment.
Impact:
The Shandra Eisenga Human Cell and Tissue Product Safety Act would have a significant impact on the safety of human cell and tissue products in the United States. It would:
- Reduce the risk of adverse events: By establishing a national registry and requiring premarket review, the bill would help to ensure that human cell and tissue products are safe and meet appropriate quality standards.
- Improve traceability: The registry would allow the FDA and manufacturers to quickly track products in the event of an adverse event, facilitating investigation and containment.
- Strengthen post-market surveillance: The bill would enhance the FDA’s ability to monitor human cell and tissue products after they have been marketed, providing additional safeguards for patients.
- Promote innovation: By providing funding for research, the bill would encourage the development of new and improved human cell and tissue products.
Outlook:
The Shandra Eisenga Human Cell and Tissue Product Safety Act is currently under consideration by the House of Representatives. It has received bipartisan support and is expected to be passed by the House with strong support. The bill’s prospects in the Senate are less certain, but it is seen as a priority for patient advocacy groups and is likely to receive consideration there as well.
H.R. 7188 (RH) – Shandra Eisenga Human Cell and Tissue Product Safety Act
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