Overview
Title
To direct the Secretary of Health and Human Services to carry out a public awareness campaign to increase participation by women in clinical trials that are conducted or supported by the National Institutes of Health, and for other purposes.
ELI5 AI
H.R. 10484 wants to help more women join in testing new medicines and to tell people about rare diseases that affect women. It gives money to share this information but doesn't say exactly how to use it wisely.
Summary AI
H.R. 10484 aims to increase women's participation in clinical trials and promote awareness about rare diseases, especially those affecting women. The bill directs the Secretary of Health and Human Services to run public awareness campaigns and establish an Interagency Task Force to improve research and treatments for rare diseases. Additionally, it authorizes funding for these initiatives and requires an action plan to coordinate efforts across departments. The proposed funding is $10 million annually from 2025 to 2029 for each campaign and task.
Published
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AnalysisAI
The proposed bill, titled the Securing Equal Access to Research, Care, and Health Act of 2024 or the "SEARCH Act of 2024," aims to address gender disparities in medical research and healthcare, particularly in clinical trials and awareness campaigns for rare diseases. Introduced in the House of Representatives, the bill would direct the Secretary of Health and Human Services to undertake specific initiatives to increase women's participation in clinical trials supported by the National Institutes of Health (NIH) and improve awareness of bleeding and clotting disorders among women. Additionally, it establishes an Interagency Task Force to enhance research and treatment for rare diseases, with an emphasis on those affecting women disproportionately.
General Summary of the Bill
The bill is structured into several key sections:
Public Awareness Campaign for NIH Clinical Trials: This section mandates a campaign to boost women's participation in NIH clinical trials, particularly for rare diseases, with an annual allocation of $10 million from 2025 to 2029.
Campaign for Bleeding and Clotting Disorders Awareness: Another campaign is proposed to increase awareness of and involvement in programs related to bleeding and clotting disorders, such as hemophilia, with similar funding as the first campaign.
Interagency Task Force for Rare Diseases: Establishes a task force to coordinate research and innovation efforts across government and private sectors to advance treatments for rare diseases and conditions, targeting those impacting women.
Coordination Action Plan: Calls for an action plan to streamline efforts by the Department of Health and Human Services (HHS) concerning research and development of products for rare diseases affecting women, requiring public accessibility and congressional submission.
Summary of Significant Issues
Several issues arise from the bill's current draft:
Funding and Accountability: While the bill allocates substantial funds toward awareness campaigns, it lacks specific guidelines on the allocation and monitoring of these funds. This absence could lead to financial inefficiencies or misuse.
Criteria for Outreach and Success Measurement: The bill does not specify criteria or metrics for selecting outreach locations or measuring the success of the campaigns, potentially hindering their effectiveness.
Task Force Composition and Duties: Concerns about potential political influence and conflicts of interest exist due to the lack of clear criteria for selecting task force members. Moreover, the broad duties assigned to the task force may lead to inefficiencies without defined goals or timelines.
Inclusion of Underrepresented Groups: The bill prioritizes women's participation without addressing other underrepresented groups in NIH clinical trials, raising ethical concerns about equitable representation.
Public Access and Transparency: The action plan lacks clarity on how the public can access it and provide feedback, which might affect transparency and public trust.
Impact on the Public and Stakeholders
Broadly, the bill could have a positive impact by increasing women's involvement in clinical trials and raising awareness of important health issues, potentially leading to more inclusive and effective medical research. By focusing on diseases that affect women disproportionately, the bill attempts to address gender imbalances in healthcare research and treatment.
However, the success of these campaigns heavily relies on well-defined strategies and accountability mechanisms. Without specific guidelines, there is a risk of ineffective resource utilization, which could diminish the bill's potential positive impact.
Stakeholders such as women patients, healthcare providers, and research institutions stand to benefit from enhanced focus and resources. For women, this could mean improved access to healthcare options and treatments tailored to their specific needs. Healthcare providers and researchers might find more opportunities and support for gender-specific studies and initiatives.
Conversely, the lack of inclusion for other underrepresented groups could lead to disparities in clinical trial participation and healthcare improvements, leaving specific populations without adequate representation or benefit.
In summary, while the bill holds promise for advancing women's participation in clinical trials and addressing rare diseases, its effectiveness will depend on careful attention to funding allocation, accountability, and inclusivity considerations.
Financial Assessment
The bill H.R. 10484, titled "Securing Equal Access to Research, Care, and Health Act of 2024," involves several financial allocations which are primarily aimed at increasing participation by women in clinical trials and raising awareness of certain health conditions that affect women. Here is a breakdown of the financial aspects of the bill:
Allocated Funds:
$10 million annually: This amount is authorized for the public awareness campaign designed to increase the participation of women in clinical trials conducted or supported by the National Institutes of Health (NIH) from the fiscal years 2025 to 2029. The campaign emphasizes targeting women to participate in trials, especially those involving rare diseases.
$10 million annually: Another allocation of $10 million annually for the same period is dedicated to a separate campaign focusing on increasing awareness of bleeding and clotting disorders, including hemophilia, among women.
Both these allocations are drawn from Section 2 and 3 of the bill. The concerns surrounding these financial allocations hinge on the lack of detailed planning and criteria, which might lead to inefficiencies and mismanagement.
Financial Management and Accountability Concerns:
The bill outlines substantial annual appropriations but lacks specifics on how these funds will be distributed and managed. This omission raises concerns about potential financial mismanagement, as highlighted in the issues section. Without clear accountability measures, there is a risk that the funds might not be used effectively.
Moreover, the absence of measurable outcomes or success criteria for these campaigns makes it challenging to monitor the appropriateness of the expenditures. This lack of clarity may render the evaluation of the campaigns' success difficult, which in turn may lead to resources being misallocated.
Interagency Task Force and Action Plan:
While the bill proposes an Interagency Task Force to advance treatments for rare diseases with no specific financial allocations tied to it, the omission of detailed budget planning for this task force might lead to inefficiencies. Furthermore, Section 5 calls for an action plan but does not specify a budget or funding source for its implementation, which questions the practicality and financial viability of this initiative.
In conclusion, while the financial allocations in H.R. 10484 indicate a strong commitment to advancing women's health issues and participation in clinical research, they are coupled with potential pitfalls related to financial oversight and effective resource utilization. The absence of detailed allocation procedures, accountability measures, and evaluation criteria pose significant challenges to the pragmatic implementation of the bill's initiatives.
Issues
The bill authorizes a substantial appropriation of $10,000,000 per fiscal year for both the public awareness campaign to increase women's participation in NIH clinical trials (Section 2) and awareness of bleeding and clotting disorders in women (Section 3) without specific details on fund allocation or accountability measures, leading to potential financial mismanagement concerns.
Sections 2 and 3 lack specific criteria for selecting appropriate outreach locations and measures of success, which may result in ineffective use of resources and difficulty in evaluating the campaigns' success, raising concerns of financial inefficiency.
The Interagency Task Force on Advancing Treatments for Rare Diseases (Section 310C) includes several appointed members, with concerns about potential political or special interest influence in the appointment process due to a lack of criteria for selecting members who are biopharmaceutical innovators, private health plan administrators, and representatives of research institutions.
The Task Force's duties in Section 310C are broad, lacking specific measurable goals or timelines, which could lead to inefficiency or lack of accountability in coordinating efforts across agencies and incentivizing research on rare diseases.
Section 2 prioritizes diseases that disproportionately impact women but does not address the potential exclusion of other underrepresented groups in NIH clinical trials, possibly leading to ethical considerations about equitable access and representation.
Section 5 does not specify a budget or funding sources for implementing the action plan for coordinating HHS efforts on rare diseases, leading to concerns about financial feasibility.
The process for public accessibility and transparency of the action plan in Section 5 is not clearly defined, potentially hindering public involvement and feedback.
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 first section of this bill assigns a short title to the legislation, stating that it can be referred to as the "Securing Equal Access to Research, Care, and Health Act of 2024" or the "SEARCH Act of 2024".
2. Public awareness campaign to increase participation of women in NIH clinical trials Read Opens in new tab
Summary AI
The bill requires the Secretary of Health and Human Services, through the National Institutes of Health, to launch a public awareness campaign aimed at increasing the number of women participating in their clinical trials, especially for trials focused on rare diseases. They are authorized to spend $10 million each year from 2025 to 2029 to support this effort.
Money References
- (d) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2025 through 2029.
3. Public awareness campaign to increase awareness of bleeding and clotting disorders in women Read Opens in new tab
Summary AI
The bill mandates that the Secretary of Health and Human Services launch a public awareness campaign aimed at increasing the number of women involved in programs related to bleeding and clotting disorders, such as hemophilia. It also allocates $10 million annually from 2025 to 2029 to fund this initiative.
Money References
- (b) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2025 through 2029.
4. Interagency Task Force on Advancing Treatments for Rare Diseases Read Opens in new tab
Summary AI
The Interagency Task Force on Advancing Treatments for Rare Diseases is established by the Secretary as a permanent group composed of key government officials and appointed experts, including biopharmaceutical innovators and rare disease advocates. Its duties include assessing federal activities and funding related to rare diseases and coordinating efforts to encourage research and development of treatments, especially for rare diseases that affect women.
310C. Interagency Task Force on Advancing Treatments for Rare Diseases Read Opens in new tab
Summary AI
The section establishes a permanent Interagency Task Force on Advancing Treatments for Rare Diseases, which will be created within 90 days of the SEARCH Act of 2024's enactment. This Task Force will include various government officials and appointed experts to assess federal activities related to rare diseases and coordinate efforts to promote research and development, especially for conditions affecting women.
5. Action plan for coordinating HHS efforts with respect to certain rare diseases and conditions Read Opens in new tab
Summary AI
The Secretary of Health and Human Services is tasked with creating a plan to better coordinate department efforts to support research and development of products focusing on rare diseases that mainly affect women. The plan must be completed within 180 days, submitted to Congress, and made available to the public online.