Sponsors (2)
Official title: Require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes.
Introduced June 24, 2026 by Gary C. Peters · Last progress June 24, 2026
The bill improves safety, oversight, and regulatory clarity for human cell and tissue products through alignment with FDA definitions, stronger enforcement, training, and transparency — but it increases liability and administrative costs and creates potential regulatory uncertainty that could hinder access to novel therapies and burden smaller providers.
Patients and health systems will face fewer unsafe or unregulated human cell and tissue products because the bill gives HHS clearer enforcement tools (per-violation/daily penalties and recovery of retail value) to deter noncompliance and remove financial incentives to sell unsafe products.
Hospitals, clinicians, and patients gain clearer, consistent legal coverage and predictability because the bill aligns the statutory definition of covered human cell and tissue products with the FDA regulatory definition and requires published guidance and best practices.
Healthcare workers and families will have better, standardized information and training on organ, tissue, and eye donation, improving consent conversations, increasing donation opportunities, and smoothing hospital donation workflows.
Clinics, tissue banks, manufacturers, and small providers face large financial liability (including fines and civil penalties up to millions), which could raise costs, discourage provision of some therapies, or drive smaller providers out of the market and thereby limit patient access.
Hospitals, developers, and patients may face significant regulatory uncertainty because the bill ties coverage and enforcement to the FDA's regulatory definitions (and successor rules), allowing the scope to shift through future FDA rulemaking or redrafting without fresh congressional approval, increasing litigation risk and planning difficulty.
Patients seeking novel or emerging cell and tissue therapies could have delayed or restricted access if the bill's reliance on technical FDA definitions excludes new therapies until FDA updates its rules.
Based on analysis of 5 sections of legislative text.
Creates civil penalties for violations of FDA human cell and tissue product rules, requires HHS/FDA education and transparency, and mandates workshops, a public docket, and a 2026 report to Congress.
Creates new civil penalties for violations of FDA rules for human cells, tissues, and cellular or tissue‑based products, and directs HHS/FDA to expand education, transparency, and stakeholder engagement about donation, Tissue Reference Group activities, and regulatory approaches. Requires publication of educational materials and annual metrics for four years, establishes a public docket and workshops on regulatory modernization, and mandates a congressional report with recommendations on regulation of these products.