This bill would require the Department of Health and Human Services (HHS), working with other agencies, to maintain a public Essential Medicines List of active pharmaceutical ingredients and drugs that are critical for emergencies, high-priority care, chronic conditions, or military readiness. HHS must update that list at least every 2 years and complete the first update within 180 days of enactment.
The bill directs HHS and other agencies to do two main related tasks: (1) conduct a comprehensive risk assessment of supply chains for medicines on the list, identifying things such as key starting materials and excipients, dependence on high-risk foreign suppliers, domestic manufacturing capacity, cybersecurity and infrastructure risks, and gaps in authorities or processes; and (2) map and visualize pharmaceutical supply chains (from starting materials through finished drugs and distribution) and use data analytics to find vulnerabilities. The bill sets deadlines for reports to Congress: the risk assessment report within 180 days and annually thereafter, and a supply-chain mapping report within 18 months and annually thereafter. It also requires the Department of Defense to send reports every 180 days listing drugs it bought that use materials or manufacturing in the People’s Republic of China.
The bill includes provisions to share information among agencies for these tasks, to protect commercially sensitive information, and to require cybersecurity protections for the exchanged data.
If enacted, HHS would publish and update a list of essential medicines and send regular public and congressional reports about supply-chain risks and mapping efforts. The Department of Defense would provide twice-yearly lists of purchases tied to China-based suppliers or manufacturing. The law would increase federal coordination and require HHS to use data analytics and mapping tools to track where ingredients and finished drugs are made.
No publicly available information.
The bill’s sponsors say the purpose is to improve coordination of federal efforts to identify and mitigate health and national security risks by maintaining an essential medicines list, assessing supply-chain risks, and creating a monitoring and mapping system using data analytics.
No publicly available information.