MAPS Act
- Bill Number
- H.R. 4191
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-06-26: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-06-24T08:08:12Z
AI-Generated Summary
Purpose of the Legislation
The Mapping America's Pharmaceutical Supply Act (MAPS Act), H.R. 4191, aims to strengthen U.S. public health and national security by improving federal coordination to track and address risks in the supply chains of essential medicines. It focuses on creating and maintaining a list of critical drugs, assessing vulnerabilities in their production and distribution, and using data tools to monitor potential disruptions like shortages or foreign dependencies.
Key Provisions
- Essential Medicines List (Section 2):
The Secretary of Health and Human Services (HHS), working with other federal agencies and experts, must update and maintain a list of essential medicines. This includes active pharmaceutical ingredients (the core chemical components of drugs) and finished drugs that:
- Respond to chemical, biological, radiological, or nuclear threats under the National Response Framework (a federal plan for disaster response).
- Are high-priority for healthcare but at risk of shortages.
- Affect patients with chronic conditions if in short supply.
The list must be reviewed at least every two years, with the first update completed within 180 days of enactment and published publicly after each update.
- Risk Assessment of Supply Chains (Section 3):
HHS, in consultation with other agencies, must perform a detailed evaluation of supply chains for listed medicines. This assessment covers:
- Key materials used in manufacturing.
- Drugs relying on foreign suppliers for over 50% of production or from a single source.
- U.S. manufacturing capabilities, including advanced technologies (like continuous production methods).
- Risks such as public health threats, national security issues (e.g., cybersecurity), and policy gaps.
- Mitigation strategies, potentially using the Defense Production Act (a law allowing government intervention in critical industries during emergencies).
A report on findings must be submitted to Congress within 180 days of enactment and annually thereafter.
- Supply Chain Mapping and Monitoring (Section 4):
HHS must coordinate with other agencies and private partners to map the full supply chain—from raw materials to final drug distribution—for essential medicines. This includes using data analytics (computer-based analysis of patterns) to spot vulnerabilities threatening health or security. Key requirements:
- Define roles for HHS offices in monitoring.
- Share information on manufacturing locations, production volumes, and regulatory actions (e.g., inspections, recalls, or shortage listings under the Federal Food, Drug, and Cosmetic Act).
An annual report to Congress, starting 18 months after enactment, must cover mapping progress, coordination efforts, data gaps, predictive modeling for shortages, and industry engagement.
- Definitions (Section 5):
Clarifies terms like "advanced manufacturing" (efficient, tech-driven drug production methods), "cybersecurity threat" (risks to digital systems under homeland security law), "drug" (as defined in federal food and drug law), and "Secretary" (HHS head).
- Additional Provisions (Section 6):
- Confirms that maintaining the list fulfills prior executive order requirements.
- Allows secure information sharing among agencies without violating trade secret laws (e.g., protecting business data under federal statutes like the Freedom of Information Act).
- Requires strong cybersecurity to safeguard shared data.
Significant Changes to Existing Law
This bill builds on Executive Order 13944 (issued in 2020 to address drug supply issues during the COVID-19 pandemic) by making the essential medicines list a permanent, regularly updated federal responsibility rather than a one-time effort. It introduces new mandates for ongoing risk assessments and data-driven supply chain mapping, which were not previously required. It also expands information-sharing protections to facilitate inter-agency work without legal conflicts, and integrates national security tools like the Defense Production Act more explicitly into pharmaceutical oversight.
Potential Impacts
- On Government Agencies: Increases coordination and reporting burdens for HHS (leading the efforts) and agencies like the Department of Defense or Homeland Security. This could streamline responses to drug shortages but require new resources for data analytics and mapping tools.
- On Citizens: Enhances access to critical medicines by reducing shortage risks, particularly for chronic illness patients or during emergencies, potentially improving healthcare reliability and lowering health risks from supply disruptions.
- On International Relations: Highlights dependencies on foreign suppliers (e.g., over 50% from abroad), which may prompt policies to diversify sources or boost domestic production, affecting trade with countries like China or India that dominate global drug manufacturing.
Main Stakeholders Affected
- Federal Government: HHS (primary implementer), other agencies (e.g., FDA for drug regulation, national security offices), and Congress (receives reports for oversight).
- Pharmaceutical Industry: Manufacturers, suppliers, and trade groups involved in public-private partnerships for data sharing and mapping.
- Healthcare Providers and Patients: Hospitals, doctors, and individuals relying on essential drugs, benefiting from reduced shortage risks.
- National Security Entities: Agencies addressing threats like cyberattacks or geopolitical disruptions to supply chains.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens confidentiality for commercial data during inter-agency sharing, avoiding violations of laws protecting trade secrets (e.g., 18 U.S.C. § 1905), while mandating cybersecurity to comply with privacy standards. It leverages existing authorities like the Defense Production Act without creating new enforcement powers.
- Constitutional: Aligns with Congress's commerce clause authority to regulate interstate and international trade in health products, promoting national welfare without infringing on private sector rights.
- Political: Bipartisan introduction (by Reps. Matsui and Crenshaw) reflects post-pandemic priorities on supply chain resilience amid geopolitical tensions. It could influence future budgets for HHS and FDA, emphasizing proactive risk management over reactive crisis response, but may face debates on industry burdens or data privacy.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Matsui, Doris O. [D-CA-7]
Cosponsors (2)
Rep. Crenshaw, Dan [R-TX-2], Rep. Bacon, Don [R-NE-2]
Recent Actions
- 2025-06-26: Referred to the House Committee on Energy and Commerce.
- 2025-06-26: Introduced in House
- 2025-06-26: Introduced in House
Bill Versions
- Mapping America’s Pharmaceutical Supply Act — issued 2025-06-26 — PDF (10 pages)