HR4191-119

What This Bill Does

The MAPS Act builds a federal map of critical pharmaceutical supply chains. HHS, coordinating with other agencies and stakeholders, must update and publish an Essential Medicines List covering drugs and active pharmaceutical ingredients tied to CBRN response, high-shortage-risk health care priorities, and chronic-condition harms. HHS must then conduct risk assessments identifying key starting materials, excipients, foreign suppliers above 50 percent of production, single-supplier dependencies, domestic manufacturing capabilities, advanced manufacturing technologies, cybersecurity threats, critical-infrastructure risks, policy gaps, and Defense Production Act mitigation options. A separate supply-chain mapping function uses public-private partnerships, establishment location and production data, agency information exchange, trade-secret protections, and cybersecurity safeguards to visualize manufacturing from key materials through finished dosage forms and distribution.

Who Benefits and How

Patients relying on essential medicines benefit because federal agencies must identify shortage, foreign-supplier, and single-supplier risks. Domestic pharmaceutical manufacturers benefit if risk assessments support investment in domestic active-ingredient and finished-dose capacity. Public health preparedness officials benefit from an updated Essential Medicines List and supply-chain vulnerability mapping. Advanced pharmaceutical manufacturing firms benefit because cost-effective technologies and domestic capabilities are part of the assessment.

Who Bears the Burden and How

The Secretary of Health and Human Services must update the Essential Medicines List, conduct risk assessments, publish reports, and coordinate mapping. Drug manufacturers must expect more federal attention to establishment locations, production amounts, suppliers, excipients, and supply-chain vulnerabilities. Federal agency data offices must exchange sensitive supply-chain information while preserving trade-secret and confidential-commercial protections. Cybersecurity officials must protect mapped pharmaceutical supply-chain data from unauthorized access or disclosure.

Key Provisions

• Requires HHS to update and publish an Essential Medicines List within 180 days and at least every two years.
• Directs annual risk assessments of listed drugs, active pharmaceutical ingredients, key starting materials, excipients, foreign reliance, and single-supplier exposure.
• Requires mapping and data analytics for essential-medicine supply chains from key materials through finished dosage forms and distribution.
• Protects trade secrets and confidential commercial information while requiring robust cybersecurity for exchanged supply-chain data.