Overview
Title
To require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes.
ELI5 AI
This bill, called the "Shandra Eisenga Human Cell and Tissue Product Safety Act," wants to teach people and doctors about the good and bad things that happen when using donated human cells and tissues. It also sets rules about penalties for breaking the law but there are worries that the penalties might be too high and that the money to teach people could be spent without a proper plan.
Summary AI
H. R. 7188, also known as the "Shandra Eisenga Human Cell and Tissue Product Safety Act," aims to increase awareness about the risks and benefits of human cell and tissue product transplants through a national education campaign run by the Secretary of Health and Human Services. It requires updating and reviewing guidance on donor eligibility and imposes civil penalties for violations related to these products. Additionally, the bill seeks to streamline regulatory oversight by making information more accessible and providing educational resources to stakeholders. It also mandates a report to Congress by 2026 to help modernize regulations considering scientific advancements and public health protections.
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AnalysisAI
The proposed legislation, H. R. 7188, titled the "Shandra Eisenga Human Cell and Tissue Product Safety Act," seeks to enhance public and healthcare provider awareness regarding the potential risks and benefits of human cell and tissue product transplants. The bill outlines a comprehensive approach by mandating the Secretary of Health and Human Services to lead a national education campaign, review and update regulatory guidance, instate penalties for regulatory violations, and streamline regulatory oversight.
General Summary of the Bill
The main objective of the bill is to ensure both the public and healthcare professionals are well-informed about human cell and tissue product transplants. This is to be achieved through educational campaigns and enhanced regulation. The bill includes definitions relevant to the regulation of human cell and tissue products, establishes a framework for penalties in cases of regulatory non-compliance, and mandates regular publication of educational materials, among other regulatory enhancements. The bill further outlines measures for reviewing and possibly updating existing guidance to ensure safety and reduce risks associated with these medical products.
Summary of Significant Issues
One issue with the bill is the potentially excessive penalties for regulatory violations, which may unduly burden smaller organizations. The bill allows for fines up to $10,000,000, a significant amount that raises concerns over its proportionality and potential impact on smaller stakeholders. Furthermore, the bill relies on ambiguous language in some sections, such as lack of defined terms and vague roles for certain professionals, which could result in inconsistencies and confusion in implementation.
Another point of concern is the lack of clarity in how penalties will be imposed, assessed, and appealed, potentially leading to inconsistent enforcement. Additionally, the bill does not clearly outline the budget or funding limits for the educational campaign, posing risks of wasteful spending. Lastly, the authority granted to certain federal officials lacks detailed oversight mechanisms, which might result in inefficiencies in regulatory execution.
Impact on the Public
The bill is designed with the public's safety and awareness in mind, aiming to equip healthcare providers and the general populace with better knowledge about human cell and tissue transplants. This could potentially lead to increased organ and tissue donations and safer transplant practices, enhancing public health outcomes.
Impact on Specific Stakeholders
Healthcare Providers and Institutions: The bill mandates educational initiatives that could benefit healthcare providers by increasing their understanding and capacity to manage transplants safely, but it also adds layers of regulatory requirements. More informed healthcare providers might assure patients of safer and more effective care.
Smaller Organizations: The civil penalties outlined could disproportionately impact smaller healthcare facilities or organizations that might struggle financially under the weight of potential fines.
Government and Regulatory Bodies: The bill extends the responsibilities of regulatory bodies like the FDA, requiring them to provide thorough oversight, review current guidelines, and engage in stakeholder education. While these enhance regulatory frameworks, they also require efficient management to prevent bureaucratic inefficiencies.
General Public: As the primary beneficiaries, the general public stands to gain from enhanced transparency and safety measures in human cell and tissue product transplants. However, adequate dissemination of information and its accessibility would be crucial to realizing these benefits.
Overall, the bill takes critical steps toward improving the awareness and regulation of human cell and tissue product transplants. However, careful consideration must be given to its practical implications, potential financial burdens, and the need for clear, measurable objectives to ensure its effectiveness and fairness across different groups.
Financial Assessment
In analyzing the financial aspects of H. R. 7188, or the "Shandra Eisenga Human Cell and Tissue Product Safety Act," several key points are relevant to understanding how money is referenced and utilized within the bill.
Civil Penalties
A significant financial component of the bill involves the imposition of civil penalties for violations related to human cell and tissue products. Section 5 of the bill introduces penalties of up to $20,000 for each violation, with an additional $20,000 for each subsequent day the violation continues after written notice is given. This can accumulate to a maximum penalty of $10,000,000 for all violations adjudicated in a single proceeding.
This section raises concerns outlined in the issues section, such as the penalties potentially being excessive, especially for smaller organizations. Such high penalties could be burdensome and might unduly impact organizations that lack the financial resources of larger entities, raising financial and ethical questions about the fairness and proportionality of the penalties levied.
Indeterminate Budget for Educational Campaign
The bill mandates a national, evidence-based education campaign to increase awareness about the potential risks and benefits of human cell and tissue product transplants. However, Section 3 does not specify any budget or funding limits for this campaign. This absence of defined financial boundaries may lead to concerns regarding wasteful expenditure of public funds, as there is no delineation of how much money can or should be spent on this initiative. The lack of financial parameters could lead to inefficiencies and uncontrolled spending, impacting the responsible use of taxpayer dollars.
Financial Reporting and Workshops
Section 6 requires annual reporting, workshops, and educational sessions to facilitate regulatory predictability and scientific advancement. The financial implications of these ongoing activities are not clearly defined, potentially resulting in substantial costs without clear objectives or outcome metrics. This raises concerns about inefficiency and wasteful spending, as the expenditures associated with these activities might increase without a corresponding benefit in terms of outcomes or public value.
Penalty Valuation Concerns
Additionally, the bill stipulates that penalties can include amounts equal to the retail value of the products involved in violations. The process for determining this retail value is not clarified, which could lead to arbitrary assessments and inconsistent penalties. The potential for subjective evaluations of product value poses a risk of unfair financial burdens being placed on organizations, depending on how such valuations are conducted and enforced.
In summary, H. R. 7188 contains several financial references that address penalties, educational campaign funding, and regulatory actions. While these efforts aim to improve oversight and safety for human cell and tissue products, they also introduce significant financial concerns about potential over-penalization, uncontrolled spending, and inconsistencies in financial management and penalty assessments. These concerns highlight the need for clear financial guidelines and accountability measures within the bill.
Issues
The civil penalties outlined in Section 5 are potentially excessive, with penalties reaching up to $10,000,000. This could disproportionately affect smaller organizations and may be considered burdensome, raising financial and ethical concerns.
The lack of specified definitions in Section 2 for terms like 'human cells, tissues, or cellular or tissue-based products' might lead to confusion, as these terms rely on external regulatory codes that are not accessible to all readers.
In Section 5, the process for how penalties will be assessed, appealed, or enforced is not clearly defined, which could lead to inconsistent enforcement and legal disputes.
Section 3 does not specify any budget or funding limits for the awareness campaign, potentially leading to wasteful spending. This raises financial concerns regarding the use of public funds.
The broad and vague language used in Section 3, such as 'other appropriate professionals' and 'other relevant aspects of donation,' could cause confusion and inconsistency in the campaign's implementation.
Section 6 gives significant authority to the Secretary and the Commissioner of Food and Drugs without clearly defined oversight mechanisms, which might result in bureaucratic inefficiencies or regulatory biases.
In Section 5, the requirement to pay penalties equal to the retail value of the products involved is not well-explained, leading to possible arbitrary valuations and unfair penalties.
Section 6 requires annual reporting and workshops that could impose considerable costs without clear objectives or performance metrics, raising concerns about potential inefficiency or wasteful spending.
Section 3 lacks specific metrics or methods for evaluating the impact of the educational campaign, which could result in inefficiency and lack of accountability for the campaign's effectiveness.
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The section provides the short title of the law, stating that it may be referred to as the “Shandra Eisenga Human Cell and Tissue Product Safety Act.”
2. Definitions Read Opens in new tab
Summary AI
This section outlines the definitions used in the Act. It explains that "human cell and tissue product" refers to certain products as defined by federal regulations, identifies the "Secretary" as the Secretary of Health and Human Services, and describes the "Tissue Reference Group" as a part of the Food and Drug Administration.
3. Human cell and tissue products transplant public awareness campaign Read Opens in new tab
Summary AI
The Secretary is tasked with creating and sharing educational materials to help inform healthcare workers and other professionals about organ, tissue, and eye donations. This includes teaching them how to approach donors and their families and providing information about donor screening tests and other important aspects of donation.
4. Review and update of existing guidance Read Opens in new tab
Summary AI
The Secretary of Health, through the Commissioner of Food and Drugs, must review existing guidelines for donor eligibility of human cells and tissue products within a year and, if needed, update the 2007 guidance and any related industry guidelines, focusing on reducing risks of diseases like tuberculosis and sepsis. If no updates are needed, they must explain their decision to specific congressional committees.
5. Civil penalties for violation of requirements for human cell and tissue products Read Opens in new tab
Summary AI
The section adds penalties for violating regulations related to human cell and tissue products. If a person violates these rules, they could be fined up to $20,000 for each violation, plus additional penalties for ongoing violations, and up to $10,000,000 total for all violations in a single case.
Money References
- Section 368 of the Public Health Service Act (42 U.S.C. 271) is amended by adding at the end the following: “(d)(1) Any person who, on or after the date of the enactment of the Shandra Eisenga Human Cell and Tissue Product Safety Act, 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 shall be liable to the United States for a civil penalty in an amount not to exceed the sum of— “(A)(i) $20,000 for each violation; and “(ii) in the case of a violation that continues after the Secretary provides written notice to such person, $20,000 for each subsequent day on which the violation continues; and “(B) an amount equal to the retail value of the human cell and tissue products that are the subject of the violation.
- “(2) The total civil penalty under paragraph (1) may not exceed $10,000,000 for all such violations adjudicated in a single proceeding.
6. Streamlining regulatory oversight of human cell and tissue products Read Opens in new tab
Summary AI
The bill aims to streamline the regulation of human cell and tissue products by requiring the publication of educational materials and inspection data, conducting stakeholder education, setting up a public docket for comments on regulation updates, and presenting a report to Congress with recommendations by 2026 to balance regulatory needs with scientific advancements and public health protection.