Sponsors (2)
The bill strengthens safety, oversight, and transparency for human cell and tissue products—improving enforcement, training, and stakeholder engagement—but does so by locking coverage to evolving FDA definitions and imposing significant enforcement and administrative costs that could create legal uncertainty and discourage smaller providers or delay access to novel therapies.
Patients and clinicians: stronger enforcement (per-violation/day penalties and recovery of retail value) and clearer enforcement authorities deter sale of unsafe or unregulated human cell and tissue products, reducing risk of contaminated biologics.
Clinicians and hospitals: aligning the statute with the FDA's regulatory definition provides a clear, consistent legal definition of covered human cell and tissue products, reducing regulatory uncertainty and improving predictability for clinical practice and coverage decisions.
Government oversight and regulatory compliance: the bill avoids creating conflicting standards with FDA (by using the FDA definition and enhancing reporting/metrics), which should streamline compliance and make HHS/FDA oversight more coherent and actionable.
Providers, patients, and developers: tying the statute to the FDA's definition and successor regulations allows the scope of covered products to change via future FDA rulemaking without new congressional action, creating ongoing legal and coverage uncertainty for many stakeholders.
Clinics, tissue banks, manufacturers and small providers: the bill imposes large financial liability (including steep fines and potential recovery of retail value, and caps up to multi‑million-dollar proceedings) that could raise costs, lead to consolidation, or discourage provision of certain therapies—especially by smaller entities.
Patients and developers: relying on a technical regulatory definition risks excluding novel or emerging cell and tissue therapies until FDA updates its rules, potentially delaying patient access and creating coverage gaps.
Based on analysis of 5 sections of legislative text.
Directs FDA to publish guidance, metrics, and workshops on human cell and tissue products, creates a public docket and report to Congress, and establishes civil fines for violations of FDA tissue regulations.
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
Requires HHS/FDA to produce and share educational materials and best practices for organ, tissue, eye, and human cell and tissue product donation and to publish regular data and hold workshops to improve regulatory clarity. Establishes civil monetary penalties for violations of FDA human cell and tissue regulations and creates a public docket and reporting requirement to Congress on regulatory approaches and modernization issues.