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) of greatest priority for providing health care and at high risk of shortage, (3) the shortage of which would adversely affect patients with chronic conditions, and (4) that the Department of Defense (DOD) determines to be critical for military preparedness. The FDA must update the list at least every two years.

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 suppliers, manufacturing capacity, relevant public health and national security risks, and risk mitigation strategies.

Additionally, the Department of Health and Human Services, in coordination with other agencies, must map and monitor relevant supply chains to identify vulnerabilities and provide an annual status report to Congress.

Summary by the Congressional Research Service.