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
The bill wants to help people and doctors know more about the good and bad parts of using special body parts called human cells and tissues for medical help. It asks a health leader to start a big campaign to share this information and make sure safety rules are followed, even giving fines if people don't follow the rules.
Summary AI
The bill, titled the “Shandra Eisenga Human Cell and Tissue Product Safety Act,” requires the Secretary of Health and Human Services to launch a national education campaign to raise awareness among the public and healthcare providers about the risks and benefits of human cell and tissue product transplants. The campaign will consider expert advice and may include media efforts to inform about potential infectious risks. Additionally, the bill imposes civil penalties for violations related to these products and mandates a report to Congress on improving their safety, as well as a review and update of donor eligibility guidelines.
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AnalysisAI
General Summary of the Bill
The proposed legislation, known as the "Shandra Eisenga Human Cell and Tissue Product Safety Act," aims to mandate a national education campaign to inform both the public and healthcare providers about the risks and benefits of human cell and tissue product transplants. It directs the Secretary of Health and Human Services to lead this initiative, with possible collaboration with nonprofit organizations and media entities to disseminate information. The bill also outlines civil penalties for regulatory violations concerning these products, requires a report to Congress on safety improvements, and mandates an update of guidance on donor eligibility within specific timeframes.
Summary of Significant Issues
One of the notable issues with the bill is its broad and sometimes vague language, particularly regarding what constitutes "evidence-based" criteria for the educational campaign, which could undermine its effectiveness. There is also ambiguity in how penalties for violations are defined and enforced, including the cap on penalties, which may not align with the severity of some violations. Additionally, the bill permits extensive discretion in media spending without clear limits, which could lead to unchecked expenses.
The drafting lacks specificity in incorporating expert advice into the educational campaign, potentially sidelining valuable stakeholder insights. Furthermore, without defined metrics for success, evaluating the effectiveness of grant-funded activities becomes challenging. Finally, the lack of detailed budget or resource allocation for updating guidance could result in inefficiencies and inadequate stakeholder consultation.
Impact on the Public
For the general public, the bill could enhance awareness about the advantages and potential health risks of human cell and tissue product transplants, potentially contributing to better-informed health decisions. However, should the educational campaign lack clarity or fail to reach its target audience effectively, the initiative might not fully achieve its informative objectives.
The legislation's approach to imposing penalties could deter unlawful practices, reinforcing safety standards for cell and tissue products. However, inconsistent enforcement and a potentially inappropriate penalty cap might limit this positive outcome.
Impact on Specific Stakeholders
Healthcare providers and tissue establishments are key stakeholders likely to be affected. More awareness and training could lead to better care and safer transplant practices, directly benefiting patients. However, entities involved in transplants might face increased scrutiny and financial penalties if found non-compliant, which could introduce operational challenges.
Nonprofit organizations might receive grants, offering opportunities to play a significant role in public education campaigns, though lack of clarity in fund distribution might spark concerns about fairness. Media companies could benefit from contracts awarded for campaign purposes; however, without defined spending guidelines, this could lead to unequal opportunities among potential contractors.
In summary, while the bill seeks to enhance safety and awareness around human cell and tissue products, its effectiveness hinges on clarifying the broad language and ensuring consistent enforcement and accountability mechanisms.
Financial Assessment
The "Shandra Eisenga Human Cell and Tissue Product Safety Act" introduces various financial elements related to the regulation and public awareness of human cell and tissue products. This commentary will explore these financial aspects in detail.
Civil Penalties
The bill outlines specific penalties for violations of regulations concerning human cell and tissue products. Section 4 mandates that any person in violation of regulation requirements could face a civil penalty up to $20,000 for each violation or each day of a continuing violation. Additionally, the violator could be liable for an amount equal to the retail value of the products in question. The maximum penalty cap for these violations is set at $10,000,000 for all violations addressed in a single proceeding.
One financial issue identified with this section is the lack of clarity on how the fine amounts are determined. The absence of specificity could result in inconsistent application and enforcement. There is also no mention of the governmental body responsible for enforcing these penalties, which could lead to ambiguity in accountability. Furthermore, the cap on penalties could be inappropriate, being either excessively lenient or overly stringent, depending on the scale and impact of violations, raising concerns about the effectiveness of the penalties as a deterrent.
Grants for Public Awareness Campaign
The bill authorizes the Secretary of Health and Human Services to award grants to nonprofit organizations. These funds are intended to increase public and healthcare provider knowledge and awareness about the risks and benefits associated with human cell and tissue product transplants. Section 3 identifies key uses for the grant funds, focusing on educating the public about possible health risks such as infectious diseases, including tuberculosis and sepsis.
However, Section 3 lacks details regarding metrics or specific goals for knowledge and awareness increases, which could result in inefficiencies or wasteful expenditure. Without defined outcomes or measures of success, it may be challenging to determine if the allocated funds are effectively enhancing public awareness.
Media Campaigns
The Secretary is given authority to fund national multimedia campaigns to further extend awareness about human cell and tissue product risks. As stated in Section 3, these campaigns can utilize a wide range of media formats, including traditional and digital channels.
There is a provision allowing the Secretary to determine any additional appropriate media, which could lead to unchecked spending if not guided by specific criteria or limits. This broad discretionary power raises concerns about potential overspending or misallocation of resources.
In summary, while the bill includes financial references and measures aimed at regulation and public awareness, several areas lack detailed guidance, potentially leading to inconsistency and inefficiency in how financial resources are utilized. Careful oversight and specific criteria may be necessary to ensure that allocated funds effectively meet the objectives of enhancing awareness and improving safety in the use of human cell and tissue products.
Issues
The language in Section 3, subsection (a) is very broad and does not specify the criteria for what constitutes 'evidence-based', which could result in an ineffective public awareness campaign if not properly defined.
In Section 4, there is no specification on how the fine amounts are determined for each violation or for each day of a continuing violation, potentially leading to inconsistent application and enforcement of the regulations.
Section 3, subsection (b) lacks details on how the advice of stakeholder experts will be incorporated into the education campaign, which might lead to oversight or misalignment with expert recommendations.
Section 4 does not specify the entity within the United States government responsible for enforcing these penalties, leading to ambiguity in enforcement accountability.
The provision in Section 3, subsection (d) (2) for using 'any other medium determined appropriate by the Secretary' is broad and could lead to unchecked spending without clear guidelines or limits on the types of media used.
The maximum penalty cap of $10,000,000 in Section 4 might be either too lenient or too strict depending on the scale and severity of the violations, raising concerns about the adequacy of punitive measures.
Section 5 mentions a report to Congress 'not later than 2 years after the date of enactment,' which might delay necessary actions to improve product safety, affecting public health priorities.
In Section 3, subsection (c) (2), there are no metrics or goals for increasing knowledge and awareness, making it difficult to evaluate the effectiveness of the grant-funded activities and potentially leading to ineffective use of funds.
Section 6 does not specify a budget or resources required for the internal review and updating process, which could lead to potential overspending or lack of resources in the effort to update guidance.
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
The section provides definitions for terms used in the Act, including "human cell and tissue establishment," which refers to a facility regulated by the Center for Biologics Evaluation and Research, and "human cell and tissue products," which refers to human cells, tissues, or similar products. It also defines "Secretary" as the Secretary of Health and Human Services.
3. Human cell and tissue products transplant public awareness campaign Read Opens in new tab
Summary AI
The bill mandates the Secretary to create a nationwide educational campaign to inform the public and healthcare providers about the risks and benefits of human cell and tissue transplants. It allows grants for nonprofit organizations to help spread awareness and for media campaigns that may use various platforms like TV, radio, and social media to increase understanding of potential infectious risks associated with such transplants.
4. Civil penalties for violation of requirements for human cell and tissue products Read Opens in new tab
Summary AI
Any person who breaks certain rules about human cell and tissue products can be fined up to $20,000 for each violation or for each day they continue breaking the rules, plus the retail value of the products involved. The maximum total penalty for such violations in a single case cannot exceed $10,000,000.
Money References
- (a) In general.—Any person who violates a requirement of section 361 of the Public Health Service Act (42 U.S.C. 264) or part 1271 of title 21, Code of Federal Regulations (or successor regulations) with respect to human cell or tissue products shall be liable to the United States for a civil penalty in an amount not to exceed the sum of— (1)(A) $20,000 for each violation; or (B) $20,000 for each day of a continuing violation; and (2) an amount equal to the retail value of the human cell and tissue products that are the subject of the violation.
- (b) Maximum penalty.—The total civil penalty under subsection (a) shall not exceed $10,000,000 for all such violations adjudicated in a single proceeding.
5. Report to Congress Read Opens in new tab
Summary AI
The Secretary is required to submit a report to Congress within two years of the Act's enactment, detailing what actions Congress and the FDA could take to enhance the safety of human cell and tissue products. The report should include an analysis of current regulations, a record of registered establishments, inspection frequencies, and suggestions for better donor screening regulations.
6. Review and update of existing guidance Read Opens in new tab
Summary AI
The Secretary, through the Commissioner of Food and Drugs, must start reviewing existing guidance for deciding who can donate human cell and tissue products within one year after the Act is enacted. Additionally, updated guidance must be issued within three years to ensure that it meets the relevant regulations.