S. 4885, Regulatory Modernization with Safety Overlay. Quorum's AI analysis reads it as a trade-off: gains for some, costs for others.
S. 4885 · Mixed
What it does
This bill requires the HHS Secretary to run a public education campaign about cell and tissue transplants, establishes civil penalties (up to $20,000 per violation, $10M cap) for companies that violate FDA regulations on human cell and tissue products, and directs the FDA to publish information about its oversight activities, hold stakeholder workshops, and report to Congress on modernizing the regulatory framework for these products. The bill is named after Shandra Eisenga, suggesting a victim-protection or safety motivation.
The analysis names pharmaceutical manufacturers (BMY, PFE, JNJ) — and 3 more groups — among the beneficiaries.
The trade-off
The $10M civil-penalty cap may be insufficient to deter violations by large pharmaceutical and biotech firms, especially if violations involve high-value products or repeated breaches.
The analysis put a high warning level on this bill. Transparency scores 65%, and the analysis found no provisions unrelated to the bill's subject.
Who is behind it
Filed by Gary Peters. Cosponsored by Roger Marshall.