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U.S. Government and Private Sector Unite to Build a Resilient Biomanufacturing Base
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On June 16, 2025, during the BIO International Convention, Mark O’Neill, Chief of Staff, Administration for Strategic Preparedness and Response (ASPR), emphasized that in an era of growing public health threats, a modern and efficient Strategic National Stockpile (SNS), paired with a robust domestic pharmaceutical supply chain, is essential to U.S. national security.
During the speech, he stressed that deeper partnerships with the private sector, cross-agency coordination, and a focused effort to reshore manufacturing and localize key materials production are the building blocks of an agile and cost-effective medical response system.
Lessons from Global Crisis: API Localization as a Matter of National Defense
The COVID-19 pandemic highlighted the United States’ over-reliance on overseas sources for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). According to ASPR’s Industrial Base Management and Supply Chain (IBMSC) office, approximately 80% of APIs are currently sourced from India and China.
Arlene Joyner, Deputy Assistant Secretary at IBMSC, stated that the government has funneled billions into expanding domestic capacity, including bringing epinephrine API manufacturing back from India to the U.S. ASPR is also working with the White House’s Made in America Office to reframe pharmaceutical manufacturing as a national security imperative.
From Tactical Response to Strategic Deployment: The Power of Prepositioning
O’Neill underscored that an SNS is not just a warehouse, but a distributed, nationwide network. One of ASPR’s key strategies involves “prepositioning”—placing resources and personnel in advance to accelerate crisis response.
IBMSC has developed a “maturity framework” to assess supply chain capabilities across dimensions such as workforce, processes, performance, and practices. By establishing baseline, advanced, and optimized levels, the government can quantify the impact of its investments and ensure accountability for every taxpayer dollar spent.
Public-Private Dialogue: Rebuilding Trust and Reinventing the Market
“The government alone didn’t get us through the last pandemic. We did it with you,” Joyner told industry attendees. ASPR emphasized that private-sector input is crucial for real-time intelligence and early disruption signals. A single phone call from an ICU nurse or a manufacturing partner can inform ASPR’s crisis planning faster than any report.
To ensure sustainability, ASPR requires all government-funded companies to submit a robust “sustainability plan.” This transforms suppliers into strategic partners, responsible not only for meeting today’s needs but also for surviving and thriving in tomorrow’s market. The agency focuses particularly on companies with existing overseas operations and proven track records in pharmaceutical production.
Policy, Regulation, and Markets: A Three-Pronged Approach to Industry Resilience
Funding alone will not solve America’s pharmaceutical vulnerabilities. IBMSC leadership emphasized the use of non-fiscal levers—such as tax incentives, regulatory streamlining, and strategic procurement preferences. Expanding the scope of the Buy America Act to include pharmaceutical products could level the playing field for domestic manufacturers facing global price competition.
ASPR is also working closely with the Food and Drug Administration (FDA) to accelerate regulatory paths for advanced manufacturing technologies, including continuous manufacturing and small-footprint production models. These approaches lower costs and enhance environmental and economic sustainability.
To manage supply chain risks, ASPR is developing a monitoring system in collaboration with institutions like the U.S. Pharmacopeia and the Advanced Regenerative Manufacturing Institute. These tools help map API vulnerabilities, detect market overconcentration, and guide future investment.
From Supply Chain Resilience to Biotechnology Sovereignty
In his closing remarks, O’Neill posed a challenge: “What kind of enterprise will still be standing in five years?” The U.S. has invested over $400 million and signed more than 127 contracts to fortify domestic pharmaceutical manufacturing. But true biotechnology sovereignty demands more than spending—it requires vertical integration between federal, state, and private entities.
Supply chain strategy must evolve from reactive to proactive. With geopolitical volatility and natural disasters on the rise, pharmaceutical access is now a cornerstone of national defense. Moving forward, federal and state governments aim to build state-level stockpiles, enhance early warning capabilities, and ensure every American has access to essential medicines—no matter the crisis.
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