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, aims to enhance the safety and awareness surrounding human cell and tissue product transplants. It mandates the Secretary of Health and Human Services to conduct a national education campaign. This campaign will target both the public and healthcare providers, focusing on the risks and benefits associated with these products.
The bill also introduces civil penalties for violations of regulations concerning human cell and tissue products. Furthermore, it seeks to streamline the regulatory oversight of these products by improving information dissemination and updating regulatory practices.
Finally, the bill requires the Secretary to publish information on the FDA website, conduct workshops, and establish a public docket for comments, culminating in a report to Congress with recommendations for modernizing regulations.
Expected Effects
The likely effect of this bill is increased awareness and safety in the use of human cell and tissue products. This will be achieved through better education and stricter regulatory enforcement.
It should also lead to more efficient regulatory processes within the FDA. This will be accomplished by providing more clarity and predictability for stakeholders.
Ultimately, the bill seeks to balance innovation with patient safety. It does this by ensuring that the regulatory framework keeps pace with scientific advancements.
Potential Benefits
- Increased public and healthcare provider awareness regarding the risks and benefits of human cell and tissue products transplants.
- Enhanced safety standards for human cell and tissue products through stricter enforcement and civil penalties for violations.
- Streamlined regulatory oversight by the FDA, leading to more efficient and predictable processes for tissue establishments.
- Improved information dissemination and education for stakeholders, including industry, researchers, and patients.
- Promotion of scientific advancement in the field of human cell and tissue products while ensuring patient safety.
Potential Disadvantages
- Potential for increased regulatory burden on tissue establishments, which could increase costs and potentially limit access to certain products.
- The civil penalties, while intended to deter violations, could disproportionately affect smaller establishments.
- The need for the Secretary to develop and disseminate educational materials and conduct workshops may strain resources within the Department of Health and Human Services.
- The public docket and report to Congress could create delays in implementing necessary regulatory updates.
- There is a risk that the focus on regulatory compliance could stifle innovation in the field of human cell and tissue products.
Constitutional Alignment
The bill aligns with the US Constitution through its promotion of the general welfare (Preamble). It does this by ensuring the safety and efficacy of human cell and tissue products.
Congress's authority to regulate interstate commerce (Article I, Section 8, Clause 3) provides the constitutional basis for regulating human cell and tissue products that are often transported across state lines.
The bill does not appear to infringe upon any individual liberties or rights protected by the Constitution or its amendments.
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).