H.R. 4191

Title

MAPS Act

Summary

Mapping America’s Pharmaceutical Supply Act or the MAPS Act This bill requires the Food and Drug Administration (FDA) to continually update its essential medicines list and identify risks and vulnerabilities in the associated supply chains. In 2020, in response to an executive order, the FDA published a list of essential medicines deemed medically necessary to have available at all times. The bill requires the FDA to update and maintain this list to include drugs and ingredients (1) related to responding to public health threats and emergency incidents, (2) that are of greatest priority for providing health care and are at high risk of shortage, and (3) the shortage of which would adversely affect patients with chronic conditions. The FDA must review the list at least every two years and update it as appropriate. Also, the bill requires the FDA to conduct a risk assessment of the supply chains for drugs and ingredients on the list and annually report its findings to Congress. The assessment must include information about key manufacturing materials, drugs with primarily foreign or single suppliers, manufacturing capacity, relevant public health and national security risks, and risk mitigation strategies. Additionally, the Department of Health and Human Services (HHS) must map and monitor relevant supply chains to identify vulnerabilities and provide an annual status report to Congress. HHS must facilitate the secure exchange of information among agencies regarding locations and quantities of production and relevant regulatory actions.

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