Overview
Title
To require the Secretary of Health and Human Services to establish a list of essential medicines, and for other purposes.
ELI5 AI
The MAPS Act wants to make sure people have the important medicines they need by having a special list and checking where medicines come from so they don't run out during emergencies, while keeping some information secret to stay safe.
Summary AI
H.R. 6992, known as the “Mapping America’s Pharmaceutical Supply Act” or "MAPS Act," instructs the Secretary of Health and Human Services to create and regularly update a list of essential medicines critical to public health and safety. This list focuses on drugs necessary to handle health emergencies and prevent shortages that could threaten public health. Additionally, the bill mandates mapping the entire U.S. pharmaceutical supply chain to identify vulnerabilities and enhance national security, while making sure sensitive commercial information remains confidential. The Secretary must also report to Congress on the implementation progress and data gaps within 18 months of the bill's enactment.
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AnalysisAI
General Summary of the Bill
H.R. 6992, titled the “Mapping America’s Pharmaceutical Supply Act” or the “MAPS Act,” seeks to empower the Secretary of Health and Human Services to establish and maintain a list of essential medicines necessary for public health emergencies and to prevent shortages in the healthcare system. The bill also aims to enhance the transparency and security of the U.S. pharmaceutical supply chain by coordinating with various federal agencies to create a comprehensive map and database of pharmaceutical production and distribution activities. This initiative is designed to identify and mitigate supply chain vulnerabilities and other national security threats.
Summary of Significant Issues
One of the primary challenges presented by this bill is the lack of specific criteria guiding the selection of essential medicines. The bill uses terms like "reasonably likely" without clear definitions, which can lead to varying interpretations and potential inconsistencies in decision-making. Furthermore, while the bill mandates a list of essential medicines, the process for public input and inclusion of such input in the final list is not clearly outlined. This lack of transparency could impact the integrity of the list's final version.
Additionally, the bill does not clearly define a budget or funding source for its initiatives, particularly the mapping and database creation related to the pharmaceutical supply chain. This omission could result in uncontrolled spending, affecting taxpayer funds. The roles of the various agencies involved are also vaguely defined, which may lead to overlapping responsibilities or gaps, hindering the effectiveness of supply chain oversight.
The bill addresses data confidentiality and sharing among agencies but does not detail how sensitive information will be protected against potential breaches, raising concerns about privacy and data security. Finally, there is a concern regarding the dual title of the act, which could create public confusion about the bill's true intent and purpose.
Impact on the Public
For the general public, this bill could significantly impact access to essential medications, especially during emergencies. By ensuring a comprehensive and up-to-date list of essential medicines, the bill promises to improve public health preparedness and response capabilities. However, the success of this outcome hinges on the bill's execution, including effective coordination and transparency in its processes.
Broadly speaking, the potential for supply chain improvements could lead to a more resilient healthcare infrastructure. Yet, these benefits may be offset by financial burdens if the bill does not address funding and budget concerns adequately. Moreover, the lack of precision regarding how public comments will influence the medicines list could lead to public distrust in the process.
Impact on Specific Stakeholders
Healthcare providers might benefit directly from this bill, as an updated list of essential medicines could streamline decision-making in emergencies, ensuring critical drugs are available and accessible. Meanwhile, pharmaceutical companies would be key stakeholders in the supply chain mapping process. The bill’s lack of specification on what constitutes industry cooperation could lead to varying levels of involvement, affecting the comprehensiveness and reliability of the pharmaceutical map.
Federal agencies tasked with implementing the bill could face challenges due to undefined roles and responsibilities, potentially complicating coordination efforts. Lastly, patients who rely on essential medications will be directly affected by the list's accuracy and completeness, underscoring the importance of clear criteria and consistent updates.
In conclusion, while the intent of H.R. 6992 is promising in aiming to bolster healthcare readiness and pharmaceutical supply chain transparency, its potential success is contingent upon clarification and proper handling of the outlined issues.
Issues
The lack of specific criteria for the selection of essential medicines beyond general descriptions in Section 2 could lead to ambiguity or inconsistency in the selection process, potentially affecting public health preparedness and response efforts.
Section 3 does not specify a clear budget or funding source for mapping the pharmaceutical supply chain, potentially resulting in undefined or uncontrolled spending and impacting taxpayer funds.
The roles of different agencies in monitoring the pharmaceutical supply chain are not clearly defined in Section 3, leading to potential overlaps or gaps in responsibilities, which could hinder effective oversight and management.
The text in Section 2 does not explain how compliance with Executive Order 13944 should be monitored or verified, which could lead to accountability concerns in ensuring the essential medicines list meets intended standards.
The absence of specified frequency for 'regular review' of the essential medicines list in Section 2 could result in outdated information or delayed updates, affecting public health response capabilities.
Section 3 lacks details on how data will be protected or what measures will ensure the security and privacy of sensitive information, potentially leading to data breaches and legal or ethical issues.
The subjective term 'reasonably likely' in Section 2 could result in differing interpretations, leading to inconsistency in determining which drugs and active pharmaceutical ingredients are included on the essential medicines list.
The act does not specify what constitutes reasonable efforts or cooperation by the industry in the supply chain mapping process in Section 3, potentially affecting the effectiveness of the mapping initiative.
Section 1's dual citation title may add unnecessary complexity, potentially leading to public confusion and ambiguity regarding the bill's purpose.
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 explains that the official name of the act is the "Mapping America’s Pharmaceutical Supply Act," which is also abbreviated as the "MAPS Act."
2. Essential medicines list update Read Opens in new tab
Summary AI
The section outlines that the Secretary of Health and Human Services must create and maintain a list of essential medicines that are important for public health emergencies or could prevent shortages in the healthcare system. The list will be based on specific criteria, be informed by existing assessments from the FDA, and require public input before finalization.
3. Federal United States pharmaceutical supply chain mapping Read Opens in new tab
Summary AI
The bill requires the Secretary of Health and Human Services, working with other agencies, to create a comprehensive map of the U.S. pharmaceutical supply chain to identify weaknesses and security risks, and to build a database of essential medicines and ingredients while ensuring confidentiality. A report on progress is to be submitted to Congress within 18 months and then annually.