H.R.340 - The HCT/P Modernization Act of 2025 (119th Congress)
Summary
H.R.340, also known as "The HCT/P Modernization Act of 2025," aims to streamline the regulatory oversight of human cell and tissue products (HCT/Ps). The bill directs the Secretary of Health and Human Services, through the FDA Commissioner, to enhance transparency and provide educational resources regarding HCT/Ps. This includes publishing information about the Tissue Reference Group and best practices for obtaining timely recommendations.
The bill also mandates the publication of data related to HCT/P establishments, inspections, and inquiries to the Tissue Reference Group. Furthermore, it requires the Secretary to conduct workshops and establish a public docket for comments on modernizing HCT/P regulation, culminating in a report to Congress with recommendations.
In short, the bill seeks to modernize the regulation of human cell and tissue products, increase transparency, and promote scientific advancement in the field.
Expected Effects
The likely effect of this bill is increased efficiency and clarity in the regulation of human cell and tissue products. This could lead to faster development and availability of new therapies.
It will also provide more information to stakeholders, including industry, researchers, and patients. The report to Congress could lead to further legislative or regulatory changes in the future.
Potential Benefits
- Increased transparency in the regulation of human cell and tissue products.
- Improved access to information for industry, researchers, and patients.
- Streamlined regulatory processes, potentially leading to faster development of new therapies.
- Enhanced regulatory predictability, fostering scientific advancement.
- Opportunities for public input through the establishment of a public docket.
Potential Disadvantages
- The bill may increase the workload of the FDA, requiring additional resources.
- Streamlining regulations could potentially lower safety standards if not carefully implemented.
- The report to Congress may not lead to significant changes in regulation.
- The benefits may primarily accrue to industry rather than patients.
- The bill's focus on streamlining may overshadow other important considerations, such as ethical concerns.
Constitutional Alignment
The bill appears to align with the US Constitution, particularly Article I, Section 8, which grants Congress the power to regulate commerce, including interstate commerce related to human cell and tissue products. The bill also aligns with the general welfare clause of the Preamble, as it aims to promote public health through the regulation of medical products. The bill does not appear to infringe on any individual liberties or rights protected by the Bill of Rights.
The bill delegates authority to the Secretary of Health and Human Services and the FDA, which is a common practice and generally permissible under the Constitution as long as Congress provides sufficient guidance and standards for the agencies to follow. The requirement for a report to Congress ensures continued oversight by the legislative branch.
Overall, the bill seems to operate within the bounds of constitutional authority and does not raise any significant constitutional concerns.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).