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Rubio, Coons Introduce Legislation to Improve Domestic Biopharmaceutical Manufacturing Capabilities for Emerging Public Health Threats

Feb 3, 2022 | Press Releases

Washington, D.C. — U.S. Senators Marco Rubio (R-FL) and Chris Coons (D-DE) introduced the Agility in Manufacturing Preparedness Act (S.3553) to require the U.S. Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA) to contract with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) for the purpose of evaluating the current capacity and vulnerabilities of biopharmaceutical manufacturing in the United States. NIIMBL is a public-private partnership focused on improving manufacturing capabilities through its cutting-edge expertise, which would help the federal government enhance its preparedness and response capabilities for emerging public health threats. Rubio and Coons first introduced this bill as an amendment (#1917) to the Senate’s Endless Frontier Act in May 2021. 
“America needs to be able to make things again, especially medicine,” Rubio said. “My new bill will help bring that back.” 
“The current global health crisis has once again underscored the importance of sustained attention to potential threats and our preparedness for them.  Expanding our manufacturing capacity in the United States and ensuring that it can respond to a variety of threats is imperative,” Coons said. “The Agility in Manufacturing Preparedness Act will put us in a position to improve our medical preparedness and support America’s health.”
The legislation specifically requires NIIMBL, in partnership with HHS, to:

  • Review current domestic biopharmaceutical manufacturing capacity at HHS and its adaptability to various threats;
  • Draft recommendations for developing, demonstrating, deploying, and advancing new domestic biopharmaceutical manufacturing technologies that address gaps in HHS’ current capabilities;
  • Aligns federal technologies with private-sector capabilities, including those through BARDA’s new BioMAP initiative; and
  • Identifies other opportunities and priorities to improve U.S. public health, medical preparedness and response capabilities, and domestic biopharmaceutical manufacturing capabilities.