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BARDA to collaborate with Manufacturing USA for biomanufacturing readiness

Expands BARDA’s authority to engage the Manufacturing USA network in biomanufacturing missions to bolster public health preparedness.

The Brief

The Agility in Manufacturing Preparedness Act of 2025 would amend the Public Health Service Act to broaden BARDA’s countermeasures authority to include manufacturing technologies and platforms. It also authorizes strategic coordination that may include collaboration with the nation’s Manufacturing USA network in biomanufacturing missions to develop, demonstrate, and deploy technologies and capabilities for public health and medical preparedness.

This is a targeted, institutionally focused change designed to link emergency-response capabilities with the nation’s advanced manufacturing ecosystem. The bill does not itself authorize new funding, but it creates a structural pathway for closer, formal collaboration between BARDA and Manufacturing USA institutions to accelerate deployment of relevant technologies during health emergencies.

At a Glance

What It Does

Amends Section 319L(c)(4)(F) of the Public Health Service Act to include manufacturing technologies, platforms and allows strategic coordination with Manufacturing USA institutes in biomanufacturing missions to improve public health preparedness.

Who It Affects

BARDA’s operations, the Manufacturing USA network, and biomanufacturing partners participating in public health preparedness initiatives, with implications for federal agencies coordinating emergency response and manufacturing.

Why It Matters

Bridges public health emergency planning with a national manufacturing ecosystem, potentially speeding development and deployment of manufacturing-enabled solutions for health crises.

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What This Bill Actually Does

The bill amends an existing public health law to explicitly broaden BARDA’s authority beyond traditional countermeasures to encompass manufacturing technologies and platforms. It further invites strategic coordination with the Manufacturing USA network, leveraging institutes under the NIST Act’s framework to pursue biomanufacturing missions intended to develop, demonstrate, and deploy technologies that strengthen public health and medical preparedness.

In practical terms, the legislation formalizes cross-program collaboration between BARDA and university-industry manufacturing consortia to align emergency-readiness activities with cutting-edge biomanufacturing capabilities. The text stops short of funding authorizations, so implementation would hinge on subsequent appropriations and agency planning, but it signals a policy shift toward integrated public health manufacturing readiness.

The Five Things You Need to Know

1

The bill amends Section 319L(c)(4)(F) to add ‘manufacturing technologies, platforms’ to BARDA’s countermeasures authority.

2

It authorizes strategic coordination that may include collaboration with the Manufacturing USA network under the NIST Act (section 34) in biomanufacturing missions.

3

The collaboration aims to develop, demonstrate, and deploy technologies and response capabilities to improve public health and medical preparedness.

4

The act designates the short title as the Agility in Manufacturing Preparedness Act of 2025.

5

The bill was introduced in the 119th Congress by Senators Tillis and Coons on April 4, 2025.

Section-by-Section Breakdown

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Section 1

Short title

Section 1 designates the act as the Agility in Manufacturing Preparedness Act of 2025, establishing its formal name and scope.

Section 2

Increases BARDA strategic initiatives

Section 2 amends the Public Health Service Act to insert ‘manufacturing technologies, platforms’ into BARDA’s countermeasures authority. It also adds that strategic coordination may include collaborating with the Manufacturing USA network, established under section 34 of the National Institute of Standards and Technology Act, in biomanufacturing missions to develop, demonstrate, and deploy technologies and response capabilities to improve public health and medical preparedness. This creates a formal pathway for cross-institution collaboration to strengthen readiness for health emergencies.

At scale

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Who Benefits and Who Bears the Cost

Every bill creates winners and losers. Here's who stands to gain and who bears the cost.

Who Benefits

  • BARDA’s program office gains a clearer mandate to engage manufacturing partners, potentially accelerating project pipelines and readiness.
  • The Manufacturing USA network gains a formal channel to contribute to public-health priorities, expanding collaboration with federal health agencies.
  • Biomanufacturing firms and research institutions participating in Manufacturing USA programs gain access to federal collaboration signals and project opportunities tied to emergency preparedness.
  • Public health and medical preparedness stakeholders may benefit from faster deployment of manufacturing-enabled solutions during health crises.

Who Bears the Cost

  • BARDA and partner agencies will allocate time and administrative resources to cross-agency coordination.
  • Manufacturing USA institutes may incur additional administrative overhead to participate in federal health-emergency projects.
  • Private sector partners could face new coordination demands and reporting requirements as part of collaborative programs.
  • Public funds (through appropriations) will be required to realize any new activities, implying budgetary tradeoffs for overlapping federal programs.

Key Issues

The Core Tension

Balancing a flexible, collaborative mandate with the need for clear governance and funding to translate collaboration into tangible readiness improvements.

The bill creates a formal collaboration pathway but leaves several implementation questions unresolved. Key concerns include how cross-agency authority is exercised—who leads joint initiatives, how projects are selected, and how results are measured—and whether new funding will be required to sustain expanded coordination.

While the language enables coordination with the Manufacturing USA network, it does not specify funding or governance structures, raising questions about oversight, accountability, and long-term sustainability of the partnerships.

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