MAPS Act
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Progress
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- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
The Mapping America’s Pharmaceutical Supply Act (MAPS Act) aims to strengthen the U.S. pharmaceutical supply chain by requiring the FDA to maintain and update a list of essential medicines, conduct risk assessments of those supply chains, and establish a system for mapping and monitoring the supply chains. The Department of Health and Human Services (HHS) will also play a role in identifying vulnerabilities and facilitating information sharing among agencies. This legislation is intended to improve the nation’s ability to respond to public health threats and national security risks related to drug availability.
Key provisions
- The FDA must maintain and update a list of essential medicines, including active pharmaceutical ingredients and drugs related to public health threats.
- The FDA must conduct an annual risk assessment of the supply chains for essential medicines, identifying key materials, single suppliers, manufacturing capacity, and potential risks.
- HHS must map and monitor pharmaceutical supply chains using data analytics to identify vulnerabilities.
- Federal agencies must share information about drug production and regulatory actions.
- The Secretary of Health and Human Services will coordinate efforts to map supply chains and assess vulnerabilities.
- The legislation establishes definitions for terms like ‘advanced manufacturing’ and ‘cybersecurity threat’.
- The FDA will review the essential medicines list at least every two years.
- The risk assessment must include how the Federal Government will mitigate national security risks.
Bill text
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