H.R.1082 - Shandra Eisenga Human Cell and Tissue Product Safety Act (119th Congress)
Summary
H.R.1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act, mandates the Secretary of Health and Human Services to conduct a national education campaign to raise awareness about the risks and benefits of human cell and tissue product transplants. It also introduces civil penalties for violations of regulations related to these products.
The Act aims to streamline regulatory oversight by requiring the FDA to publish educational materials and data related to tissue products. It also establishes a public docket for comments on modernizing regulations.
Finally, the Act directs the Secretary to report to Congress with recommendations on regulating human cell and tissue products, considering regulatory burden, scientific developments, access, and public health.
Expected Effects
This act will likely increase public and healthcare provider awareness regarding human cell and tissue products. It will also enhance regulatory oversight and enforcement in this sector.
The increased penalties may deter violations, leading to safer practices. The public docket and reporting requirements could lead to more informed and responsive regulations.
Ultimately, the act is intended to improve the safety and efficacy of human cell and tissue product transplants, benefiting patients and the healthcare system.
Potential Benefits 4/5
- Increased awareness among healthcare professionals and the public regarding the risks and benefits of human cell and tissue products.
- Enhanced regulatory oversight of human cell and tissue products, potentially leading to safer products and practices.
- Streamlined processes for obtaining recommendations from the Tissue Reference Group, improving efficiency.
- Opportunities for stakeholders to provide input on modernizing regulations through the public docket.
- Improved access to information and best practices related to human cell and tissue products through the FDA website.
Potential Disadvantages
- Increased regulatory burden on establishments dealing with human cell and tissue products, potentially increasing costs.
- Potential for civil penalties to disproportionately affect smaller establishments.
- The effectiveness of the public awareness campaign may be limited if not properly funded and implemented.
- The report to Congress and subsequent recommendations may take several years to materialize into concrete regulatory changes.
- There is a risk that the focus on regulation could stifle innovation in the field of human cell and tissue products.
Constitutional Alignment 5/5
The Act appears to align with the Constitution's broad mandate to "promote the general Welfare" (Preamble). By aiming to improve the safety and efficacy of human cell and tissue products, the Act falls under the purview of public health, which is a legitimate area for Congressional action.
There are no apparent infringements on individual liberties or rights as defined in the Bill of Rights. The Act does not appear to violate any specific constitutional provision.
The Act's delegation of authority to the Secretary of Health and Human Services and the FDA is consistent with established practices and does not raise significant constitutional concerns, provided that the delegated authority is exercised within reasonable bounds and subject to judicial review.
Impact Assessment: Things You Care About
This action has been evaluated across 19 key areas that matter to citizens. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).