The "Shandra Eisenga Human Cell and Tissue Product Safety Act" aims to improve the safety and oversight of human cell and tissue products through increased public awareness, stricter penalties for violations, and streamlined regulatory processes.
John Moolenaar
Representative
MI-2
The Shandra Eisenga Human Cell and Tissue Product Safety Act aims to improve the safety and oversight of human cell and tissue products by increasing public awareness, establishing civil penalties for violations of regulations, and streamlining the regulatory process. It mandates the creation of educational materials, sets penalties for non-compliance, and requires the FDA to publish information and reports related to tissue product regulation. The Act also focuses on stakeholder education, updating scientific practices, and gathering public input to modernize the regulation of human cell and tissue products, with a final report to Congress due by September 30, 2026.
Shandra Eisenga Act: New Rules and Penalties for Human Cell and Tissue Products, Plus FDA Oversight Tweaks
The "Shandra Eisenga Human Cell and Tissue Product Safety Act" aims to tighten up the rules around human cell and tissue products – things like skin grafts, bone marrow transplants, and emerging stem cell therapies. The bill does a few key things: pushes for better education for healthcare pros, slaps hefty fines on companies that break the rules, and streamlines how the FDA oversees this rapidly evolving field.
Getting the Word Out
The bill kicks off by requiring the Secretary of Health and Human Services to get educational materials out to doctors, nurses, and other professionals. This isn't just about the technical side of transplants; it's also about how to talk to patients and families about donation, what tests are available, and other need-to-know info. Think of it like a mandatory training program to make sure everyone's on the same page when it comes to these life-changing procedures.
Hitting Rule-Breakers Where It Hurts: New Penalties
This is where the bill gets serious. If a company violates regulations around handling or processing these human cells and tissues (specifically, subparts C or D of section 1271 of title 21, Code of Federal Regulations), they could face some major financial penalties. We're talking up to $20,000 per violation, plus another $20,000 for each day the violation continues after the FDA sends a written notice. On top of that, they could be fined the entire retail value of the products involved. The total penalty is capped at $10 million per proceeding – but that's still a huge chunk of change. For example, If a company improperly stores tissue samples, leading to contamination, they could be fined for each contaminated sample and for every day they don't fix the problem.
Streamlining the FDA's Job (For Better or Worse?)
The bill also wants the FDA to streamline its oversight. This includes publishing info about the Tissue Reference Group (the folks who give advice on these products) and best practices online. The FDA will also have to publish annual reports for three years, starting within a year of the bill's enactment. These reports will cover things like how many new tissue establishments registered, how many inspections the FDA did (and how that compares to blood bank inspections), and how long it takes the Tissue Reference Group to respond to questions. This part is all about making the process more transparent and, hopefully, more efficient. The agency will also be required to hold workshops and gather input on how to modernize these regulations, with a report due to Congress by September 30, 2026.
While transparency and efficiency sound good, it's worth keeping an eye on how "streamlining" plays out in practice. Less red tape could mean faster access to new treatments, but it could also mean less oversight, which is a concern when dealing with something as sensitive as human cells and tissues. The bill tries to balance this by requiring the FDA to consider the "regulatory burden," "scientific developments," "access to these products," and "public health protection" when making recommendations. But, the devil, as always, will be in the details.