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119-hr-1082119th CongressWALLET

Shandra Eisenga Human Cell and Tissue Product Safety Act

Sponsored By: Representative Moolenaar, John R. [R-MI-2]

Passed House

Summary

This bill would strengthen safety and oversight of human cell and tissue products by clarifying key definitions, boosting education for clinicians and donors, and adding civil penalties for regulatory violations.

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  • Patients and donors would see clearer public information on donation, available screening tests, and Tissue Reference Group timelines through FDA-published materials and annual reports on registered establishments, inspections since 2019, inquiries, and average response times.
  • Clinicians and transplant teams would get targeted educational materials, workshops, and interactive sessions to improve how they approach donation and obtain timely, accurate recommendations from the Tissue Reference Group.
  • HCTP establishments and other regulated entities would face civil penalties of up to $20,000 per violation and $20,000 per day after notice, plus the retail value of the products, with a $10.0 million cap per proceeding; the bill also creates a public docket and a workshop to inform updated recommendations on regulation, with a summary and recommendations due by September 30, 2026.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 1 benefits, 1 costs, 0 mixed.

Big fines for tissue product violations

If enacted, businesses that break FDA tissue product rules would face large fines. The bill would set $20,000 for each violation. After written notice, it would add $20,000 for each day the violation continues. It would also charge the retail value of the products involved. Total penalties in one case could not exceed $10 million. These penalties would apply to violations on or after the date of enactment.

FDA would update tissue product rules

The FDA would open a public docket within 60 days to get comments on modernizing tissue product rules. Within 1 year, and then yearly for 3 years, the FDA would post key metrics on its website. These include registered establishments since 2019, inspection counts with blood-bank comparisons, Tissue Reference Group inquiries, and average response times. The FDA would post plain-language guides about the Tissue Reference Group and how to get timely recommendations. HHS would run workshops and update best practices to focus on generating scientific data for cell and tissue therapies, including stem cell products. HHS would share donation and donor screening materials for clinicians and give regulation recommendations by September 30, 2026.

Sponsors & CoSponsors

Sponsor

Moolenaar, John R. [R-MI-2]

MI • R

Cosponsors

  • Rep. Dingell, Debbie [D-MI-6]

    MI • D

    Sponsored 2/6/2025

Roll Call Votes

No roll call votes available for this bill.

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