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This bill matters because it aims to improve public safety and transparency in a vital area of medicine: the use of human cell and tissue products for transplants and other therapies. If this bill becomes law, both patients and healthcare providers would be better informed about these medical products, allowing them to make more educated decisions and understand potential risks. The introduction of civil penalties provides a stronger deterrent against companies that might disregard safety regulations, potentially preventing unsafe products from reaching patients and improving the overall quality of these crucial medical materials.
Without this bill, public and professional awareness regarding human cell and tissue products might remain inconsistent, and the tools for enforcing existing regulations could be less effective. Voters should care because this legislation could lead to safer medical treatments, more informed healthcare choices, and greater accountability from companies that handle these essential biological products. It seeks to update how these products are overseen, balancing scientific progress with the protection of public health, which has a direct impact on the well-being of many Americans.
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This bill matters because it aims to improve public safety and transparency in a vital area of medicine: the use of human cell and tissue products for transplants and other therapies. If this bill becomes law, both patients and healthcare providers would be better informed about these medical products, allowing them to make more educated decisions and understand potential risks. The introduction of civil penalties provides a stronger deterrent against companies that might disregard safety regulations, potentially preventing unsafe products from reaching patients and improving the overall quality of these crucial medical materials.
Without this bill, public and professional awareness regarding human cell and tissue products might remain inconsistent, and the tools for enforcing existing regulations could be less effective. Voters should care because this legislation could lead to safer medical treatments, more informed healthcare choices, and greater accountability from companies that handle these essential biological products. It seeks to update how these products are overseen, balancing scientific progress with the protection of public health, which has a direct impact on the well-being of many Americans.
An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)
An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)
| TYPE | AMOUNT | WHO |
|---|---|---|
| civil | Up to $20,000 for each violation; $20,000 for each subsequent day a violation continues after written notice; plus an amount equal to the retail value of the human cell and tissue products that are the subject of the violation, with a total cap of $10,000,000 for all such violations adjudicated in a single proceeding. | Any person who violates a requirement of subparts C or D of section 1271 of title 21, Code of Federal Regulations, (or successor regulations) with respect to human cell or tissue products regulated under section 361. |