Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
The bill requires HHS to run an evidence-based public and provider education campaign about human cell and tissue products; increases transparency and stakeholder engagement around FDA Tissue Reference Group processes; creates a public docket and a September 30, 2026 report to Congress on modernizing regulation; and adds civil monetary penalties for violations of FDA 21 C.F.R. part 1271 subparts C and D, including per-violation fines, daily continuing violation fines, retail-value forfeiture, and a $10 million cap per proceeding.
Progressives emphasize patient safety and enforcement benefits
Relative to its intended legislative type, this bill combines substantive legal changes (new civil penalties and statutory amendments) with administrative requirements (education, transparency, workshops) and reporting obligations.
The bill requires HHS to run an evidence-based public and provider education campaign about human cell and tissue products; increases transparency and stakeholder engagement around FDA Tissue Reference Group processes; creates a public docket and a September 30, 2026 report to Congress on modernizing regulation; and adds civil monetary penalties for violations of FDA 21 C.F.R. part 1271 subparts C and D, including per-violation fines, daily continuing violation fines, retail-value forfeiture, and a $10 million cap per proceeding.
Moderate-to-high chance based on narrow, technical scope, stakeholder engagement steps, and modest fiscal footprint; enforcement details and Senate process are uncertainties.
Relative to its intended legislative type, this bill combines substantive legal changes (new civil penalties and statutory amendments) with administrative requirements (education, transparency, workshops) and reporting obligations. It is generally specific about penalties, responsible actors, and timelines, and it integrates with existing statutes and regulations, but it does not address funding, administrative enforcement processes, or mitigation/exemption mechanisms.
Progressives emphasize patient safety and enforcement benefits
These are examples from the analysis, not a ranked list of the most-affected groups.
Progressives emphasize patient safety and enforcement benefits
Generally supportive.
Values stronger patient safety, public education, and transparency.
Will want enforcement to protect patients while watching for access harms and equity impacts.
Cautiously positive.
Appreciates evidence-based education, transparency, and regulatory modernization.
Seeks clear timelines, cost estimates, and balanced enforcement to avoid unintended consequences.
Skeptical.
Supports patient safety and streamlined processes but worries about expanded federal penalties, regulatory overreach, and negative effects on innovation and access.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Moderate-to-high chance based on narrow, technical scope, stakeholder engagement steps, and modest fiscal footprint; enforcement details and Senate process are uncertainties.
The bill has not accumulated any surfaced votes yet.
Progressives emphasize patient safety and enforcement benefits
Moderate-to-high chance based on narrow, technical scope, stakeholder engagement steps, and modest fiscal footprint; enforcement details an…
Relative to its intended legislative type, this bill combines substantive legal changes (new civil penalties and statutory amendments) with administrative requirements (education, transparency, workshops) and reporting…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.