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Requires HHS and FDA to expand education, transparency, and stakeholder outreach about human cell and tissue products and establishes new civil monetary penalties for violations of FDA tissue regulations. The bill directs the agencies to publish educational materials and best practices, open a public docket within 60 days for workshop input, and deliver a report to Congress by September 30, 2026 summarizing comments and regulatory recommendations. It sets financial penalties for persons who violate specified FDA tissue rules: $20,000 per violation, $20,000 per day after notice, plus the retail value of the products, with a maximum recoverable amount of $10,000,000 in a single proceeding.
The bill increases regulatory clarity, transparency, and enforcement to improve patient safety and predictability for cell- and tissue-based products, but does so at the cost of significant compliance and administrative burdens—with financial penalties and unfunded implementation risks that could deter providers and unevenly affect access.
Hospitals, health systems, researchers, and state regulators gain clearer regulatory definitions and a designated implementation authority (Secretary and Tissue Reference Group), improving predictability about which cell and tissue products are covered and reducing regulatory uncertainty.
Patients and hospitals benefit from stronger enforcement tools and higher penalties that deter unsafe distribution of human cell and tissue products, reducing exposure to contaminated or noncompliant products and improving patient safety.
Healthcare professionals and hospitals receive standardized, evidence-based education and accessible donor-screening materials that help integrate donation processes into clinical workflows and may increase donor registration and organ availability.
Regulated entities (hospitals, tissue processors, contractors) face substantial financial liability—statutory penalties and remedies that can reach into the millions—raising compliance costs and risking business disruption.
Patients and providers may lose access to some cell- and tissue-based therapies because high penalties and recovery of product value could deter manufacturers or suppliers from offering certain products.
Hospitals, clinicians, and HHS may bear unfunded implementation costs for mandated education and outreach, creating an unfunded mandate on providers and potentially slowing or limiting uptake of the required materials.
Introduced February 6, 2025 by John Moolenaar · Last progress June 24, 2025