FDA gets new teeth to police cell transplants; industry gets a say in rewriting rules
H.R. 1082 — Shandra Eisenga Human Cell and Tissue Product Safety Act · Filed by John Moolenaar (R-MI) · 1 cosponsor · Introduced Feb 6, 2025 · Passed chamber
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What it does
This bill requires the FDA to run a public education campaign about cell and tissue transplants, establishes civil penalties (up to $20,000 per violation, capped at $10 million per proceeding) for companies that violate FDA regulations on human cell and tissue products, and directs the FDA to publish data on inspections, registrations, and regulatory timelines while holding public workshops and a docket to modernize how these products are regulated.
Why we flagged it
The bill's operative mechanism is twofold: (1) establishing civil penalties for FDA violations in cell/tissue product regulation, and (2) mandating public transparency and stakeholder engagement on regulatory modernization. Both are enforcement and accountability measures, not industry carve-outs.
What the text implies
- The $10 million cap on civil penalties per proceeding may limit deterrence if multiple violations occur in a single case, potentially allowing large manufacturers to treat penalties as a cost of doing business rather than a serious enforcement tool.
- The bill directs the FDA to hold public workshops and establish a docket on 'modernizing' cell/tissue product regulation, including review of 'minimal manipulation' and 'homologous use' standards—concepts that industry has long sought to relax. The outcome of this process is not predetermined, but the framing invites regulatory streamlining that could reduce safety oversight.
- Requiring annual reporting of inspection data and Tissue Reference Group response times creates transparency, but the bill does not mandate enforcement action if inspection rates or response times fall below public-health benchmarks, limiting the practical impact of disclosure.
- The education campaign focuses on 'risks and benefits' of transplants, which is appropriate, but the bill does not specify that educational materials must highlight FDA enforcement actions or safety violations, potentially allowing a balanced-tone campaign that obscures serious safety issues.
Section numbers refer to the bill text the analysis read — linked under Primary records below.
Who it affects
The bill strengthens FDA enforcement against unsafe cell and tissue products through new civil penalties, increases transparency by requiring public reporting of inspection data and regulatory timelines, and mandates patient/provider education about donation and transplant risks. These protections and accountability measures benefit ordinary people receiving or considering these treatments.
Who stands to gain
- cell and tissue product manufacturers
- tissue establishments
- biomedical consortia and research organizations
Named in the bill
FDA (Food and Drug Administration), HHS (Department of Health and Human Services), Tissue Reference Group, Bristol Myers Squibb (BMY), Grifols (GH), Pfizer (PFE), DaVita (DVA), Johnson & Johnson (JNJ)
Where it stands
1 cosponsor: 1 Democrats.
- Feb 6, 2025 — Introduced · Congress.gov: “Introduced in House”
- Feb 6, 2025 — Referred to House Committee on Energy and Commerce and Senate Committee on Health, Education, Labor, and Pensions · Congress.gov: “Referred to the House Committee on Energy and Commerce”
- Apr 29, 2025 — Markup held in committee · Congress.gov: “Committee Consideration and Mark-up Session Held”
- Apr 29, 2025 — Reported out of committee · Congress.gov: “Ordered to be Reported by Voice Vote”
- Jun 23, 2025 — Passed the House · Congress.gov: “On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)”
- Jun 23, 2025 — Floor vote scheduled · Congress.gov: “Mr. Bilirakis moved to suspend the rules and pass the bill”
Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.
Money around this bill
1 lobbying clients named this bill on 2 disclosure filings across 2 quarters, Dec 2025 to Jun 2026. Those filings disclosed $300,000 in lobbying spend. A filing names 16 bills on average, so that figure is what each filing reported, not a share belonging to this bill.
More lobbying clients named this bill than 0% of bills with at least one filing.
John Moolenaar, the sponsor, reported $595,100 in PAC receipts in the 2026 cycle.
- University of Michigan — $300,000 on 2 filings
Lobbying Disclosure Act filings through Jul 20, 2026. A filing shows who paid to lobby on a bill it names, not what changed.
How this was measured
Analysis — Quorum's AI read the bill text published by Congress.gov (6,162 characters) on Jun 10, 2026. Section numbers in the findings refer to that text, linked below; transparency and hidden-provision scores are compared against the median of 16,222 analysed bills.
Status and sponsors — Congress.gov's bill record — actions, committee referrals and cosponsors — loaded nightly. The timeline shows status changes, not every procedural action.
Money — Senate Lobbying Disclosure Act filings whose specific-issue field names this bill for quarters ending Dec 2025 to Jun 2026. A filing's amount is reported whole beside the median number of bills a filing names; it is never divided across them. PAC receipts are FEC-reported contributions to the sponsor's candidate committee in the 2026 cycle.
As of — lobbying records through Jul 20, 2026 · page rendered 2026-10-20.
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