This bill establishes civil penalties for violations of regulations governing the donation and handling of human cell and tissue products. It also requires the Food and Drug Administration (FDA) to report on the regulation of these products and to provide related information to stakeholders. (Human cell and tissue products are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.)
Specifically, the bill establishes civil penalties for violations of the FDA’s regulations on donor eligibility and current good tissue practice for manufacturing and distributing human cell and tissue products.
Also, the bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion on the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and report to Congress with recommendations. The bill also requires the FDA to support the development of educational materials for health care professionals regarding organ, tissue, and eye donations and related topics.
Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group (a working group within the FDA) and best practices for obtaining a recommendation from them about human cell and tissue products. Also, annually for three years, the FDA must publish on its website information on inquiries submitted to the Tissue Reference Group and FDA registrations and inspections regarding human cell and tissue manufacturers.
