Agility in Manufacturing Preparedness Act of 2025
- Bill Number
- S. 1305
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-04-04: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2025-05-05T13:09:04Z
AI-Generated Summary
Purpose
The Agility in Manufacturing Preparedness Act of 2025 aims to enhance collaboration between the Biomedical Advanced Research and Development Authority (BARDA)—a federal agency focused on developing medical countermeasures for public health emergencies—and the network of Manufacturing USA institutes. These institutes are federally supported hubs that advance manufacturing innovation, particularly in areas like biomanufacturing (the use of biological processes to produce medicines and health products). The goal is to improve the speed and effectiveness of developing technologies for public health and medical preparedness.
Key Provisions
- Expansion of BARDA's Strategic Initiatives: The bill amends Section 319L(c)(4)(F) of the Public Health Service Act, which governs BARDA's activities.
- It broadens BARDA's focus on "countermeasures" (such as vaccines, drugs, and diagnostics for health threats) to explicitly include "manufacturing technologies and platforms" in its strategic planning and coordination efforts.
- It adds a new requirement for BARDA to collaborate with Manufacturing USA institutes on biomanufacturing projects. This collaboration would involve developing, demonstrating, and deploying technologies to strengthen response capabilities for public health emergencies.
Significant Changes to Existing Law
- The amendment inserts specific language into an existing section of the Public Health Service Act to integrate manufacturing expertise into BARDA's operations.
- Previously, BARDA's strategic coordination emphasized countermeasures but did not explicitly mention manufacturing technologies or partnerships with Manufacturing USA. The new text makes these elements mandatory options for coordination, creating a formal pathway for joint biomanufacturing initiatives without overhauling the entire framework.
Potential Impacts
- On Government Agencies: BARDA and the National Institute of Standards and Technology (NIST), which oversees Manufacturing USA, would gain tools for more integrated operations. This could streamline federal efforts in health security, reducing silos between research, development, and manufacturing.
- On Citizens: Improved preparedness for pandemics or bioterrorism threats, potentially leading to faster production of medical supplies and treatments, enhancing national public health resilience.
- On International Relations: Minimal direct impact, though stronger domestic biomanufacturing could indirectly bolster U.S. leadership in global health responses, such as through sharing technologies with allies.
Main Stakeholders Affected
- Federal Agencies: BARDA (under the Department of Health and Human Services) and Manufacturing USA institutes (linked to NIST under the Department of Commerce).
- Industry and Research Community: Biomedical companies, biomanufacturing firms, and academic partners involved in health technology development.
- Public Health Sector: Hospitals, emergency responders, and state/local health departments that rely on rapid medical countermeasures.
- General Public: Indirectly benefits all U.S. citizens through enhanced national security against health threats.
Notable Legal, Constitutional, or Political Implications
- Legal: The changes are narrowly targeted amendments that build on existing authorities under the Public Health Service Act, avoiding new regulatory burdens. No challenges to separation of powers or federalism are evident, as it operates within established federal health and manufacturing programs.
- Constitutional: Aligns with Congress's enumerated powers to provide for the general welfare and national defense, particularly in public health emergencies.
- Political: Introduced bipartisanship (by Senators Tillis and Coons) suggests broad support for strengthening domestic manufacturing in health security, potentially influencing future funding debates without major controversy. Referred to the Senate Committee on Health, Education, Labor, and Pensions for further review.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Sen. Coons, Christopher A. [D-DE]
Recent Actions
- 2025-04-04: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2025-04-04: Introduced in Senate
Bill Versions
- Agility in Manufacturing Preparedness Act of 2025 — issued 2025-04-04 — PDF (2 pages)