S. 1784 — MAPS Act

This section directs the Secretary of Health and Human Services (HHS), in coordination with other relevant federal agencies and consulting stakeholders, to update and maintain the Essential Medicines List—initially developed pursuant to Executive Order 13944—to include active pharmaceutical ingredients and drugs that (1) relate directly to responding to chemical, biological, radiological, or nuclear (CBRN) threats and incidents under the National Response Framework; (2) are of greatest priority for health care and at high risk of shortage; (3) if in shortage would pose adverse health outcomes for patients with chronic conditions; or (4) the Secretary of Defense determines are critical for military preparedness. The Secretary must complete the initial update within 180 days of enactment, update the list regularly (at least every two years), and publish it promptly after each update.

This section directs the Secretary, in coordination with the Secretary of Defense and in consultation with other relevant agency heads, to conduct a comprehensive risk assessment of supply chains for active pharmaceutical ingredients and drugs on the Essential Medicines List. At a minimum, the assessment must identify (1) key starting materials and excipients; (2) list items relying on a high-risk foreign supplier or foreign entity of concern for more than 50% of production; (3) list items sourced exclusively or primarily from foreign establishments; (4) current domestic manufacturing capabilities and cost-effective technologies; (5) public health and national security risks, including cybersecurity threats; (6) federal deficiencies or limitations; and (7) mitigation plans, including under the Defense Production Act of 1950. Not later than 180 days after enactment, and annually thereafter, the Secretary must submit a report with these findings to the Senate Committees on Armed Services, Health, Education, Labor, and Pensions, and Homeland Security and Governmental Affairs; the House Committees on Armed Services, Energy and Commerce, and Homeland Security; and the Office of the Director of National Intelligence; with a public version required not later than 1 year after enactment.

This section directs the Secretary of Health and Human Services (HHS), in coordination with other relevant federal agencies, to map supply chains—from manufacturing of key starting materials through finished dosage forms and distribution—of drugs (as defined in 21 U.S.C. 321(g)) on the Essential Medicines List under section 2 of this Act and to use data analytics to identify national security vulnerabilities. In doing so, the Secretary must (1) describe roles and responsibilities of HHS agencies and offices for monitoring such supply chains and vulnerabilities and (2) facilitate information exchange among federal entities on registered establishments' locations and production amounts of active pharmaceutical ingredients, key starting materials, excipients, and finished dosage forms, as well as related regulatory actions (e.g., inspections, seizures, recalls, drug shortages). Not later than 18 months after enactment and annually thereafter, the Secretary must report to relevant congressional committees on mapping and analysis status, coordination activities, identified roles and gaps, federal use of predictive modeling for shortages or risks, and industry engagement.

This section requires the Secretary of Defense, not later than 180 days after enactment and every 180 days thereafter, to submit to the congressional committees specified in section 3(c)(1)(A) and (B) a report listing all drugs purchased by the Department of Defense during the preceding 180-day period (1) that contain key starting materials, excipients, or active pharmaceutical ingredients sourced from the People's Republic of China; or (2) for which the finished drug product was manufactured in the People's Republic of China.

This section defines key terms for purposes of the Act: (1) advanced manufacturing, as advanced and continuous pharmaceutical manufacturing under section 3016(h) of the 21st Century Cures Act (21 U.S.C. 399h(h)); (2) cybersecurity threat, as under section 2200 of the Homeland Security Act of 2002 (6 U.S.C. 650); (3) drug, as under section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)); and (4) Secretary, as the Secretary of Health and Human Services, except as otherwise specified.

This section provides additional provisions related to implementation of the essential medicines list. Specifically, it (1) deems the Secretary's participation in developing and updating the list under section 2 to satisfy requirements applicable to the Secretary under section 3 of Executive Order 13944 (i.e., Promoting Small Modular Reactors for National Defense and Space Exploration); (2) specifies that information exchanges among the Secretary and heads of relevant federal departments and agencies to carry out sections 3 and 4 do not violate 18 U.S.C. 1905 (i.e., prohibition on unauthorized disclosure of confidential commercial or trade secret information by federal officers and employees), without affecting the information's status under specified laws; and (3) directs the Secretary to ensure robust cybersecurity measures to prevent inappropriate access to or unauthorized disclosure of such information.