Tuesday 8 August 2023

Bill to Map the United States Pharmaceutical Supply Chain

A fair amount of concern has been raised concerning the security of supply chains, including the pharmaceutical supply chain.  U.S. Senator Gary Peters (Michigan) has introduced legislation to make a step in the direction of protecting the pharmaceutical supply chain.  The Press Release states:

U.S. Senator Gary Peters (MI), Chairman of the Homeland Security and Governmental Affairs Committee, introduced bipartisan legislation that would help the federal government better prepare for future public health threats by creating a database to map vulnerabilities in the pharmaceutical supply chain. The database would include the country of origin, quantity and other key information about critical drug products to identify supply chain weaknesses that could lead to shortages or other challenges in a future public health emergency.

The legislation builds on recommendations from two reports released by Peters in 2019 and 2023 that identified national security concerns related to our nation’s overdependence on foreign sources for critical drug products and insufficient visibility into U.S. pharmaceutical supply chains. Peters’ 2023 report found that both industry and the federal government lack visibility into the entire pharmaceutical supply chain – from the key ingredients needed to make drugs to the distribution of those products, presenting both health and national security risks. The COVID-19 pandemic exacerbated many of these longstanding challenges, and a 2022 Peters report examining the federal pandemic response found that federal agencies struggled to obtain needed supply chain data in critical early months that could have informed federal actions to mitigate shortages.  

“As we saw firsthand during the COVID-19 pandemic, federal agencies did not have enough visibility into our reliance on foreign manufacturers and other chokepoints in the supply chain, limiting their ability to anticipate and respond to drug shortages and related challenges,” said Senator Peters. “This bipartisan legislation will provide the federal government with a more comprehensive understanding of the weaknesses in our pharmaceutical supply chains so we can take steps to address them and prevent future shortages.”

The Mapping America’s Pharmaceutical Supply (MAPS) Act would require the Secretary of the Department of Health and Human Services (HHS) to establish a federal database to map the origin of each drug, the location of the facilities used to manufacture them, and associated inspections and risks, such as recalls and import alerts. HHS will use this information to make data-driven decisions on supply chain threats and how to increase resiliency through strategic investments in domestic manufacturing. The bill also requires HHS to report to Congress on how they are using the database to predict and prevent vulnerabilities for critical drug supply chains and what gaps in data remain.

This legislation follows Peters’ efforts to mitigate national security risks within the pharmaceutical industry. This Congress, he introduced a bipartisan bill to address the U.S. dependency on foreign drug manufactures. Earlier this year, as Chairman of HSAGC, Peters released a report and convened a hearing on the national security risks presented by continued drug shortages.

No comments: