Senators Coons, Rubio reintroduce legislation to improve domestic biopharmaceutical manufacturing capabilities for emerging public health threats

Source: United States Senator for Delaware Christopher Coons

WASHINGTON — U.S. Senators Chris Coons (D-Del.) and Marco Rubio (R-Fla.) reintroduced the Agility in Manufacturing Preparedness Act this week 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. Senators Rubio and Coons first introduced this bill as an amendment to the Senate’s Endless Frontier Act in May 2021 and again as a standalone bill in 2022. 

“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 we are ready to swiftly respond to the next threat – whether another pandemic or something else – is imperative,” said Senator Coons. “The Agility in Manufacturing Preparedness Act will improve our medical preparedness and bring new jobs in STEM production back to the United States.” 

“The secret to America’s economic success has been our ability to make things and to innovate for the future. When we do both, we create stable, well-paying jobs that power a strong country. This bill will help small firms engaged in manufacturing production secure the capital they need without the demand for immediate, outsized returns. The success of these companies is critical to confronting the threat posed by the Chinese Communist Party and to bringing good jobs back to America,” said Senator Rubio. 

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;
  • Align federal technologies with private-sector capabilities, including those through BARDA’s new BioMAP initiative; and
  • Identify other opportunities and priorities to improve U.S. public health, medical preparedness and response capabilities, and domestic biopharmaceutical manufacturing capabilities.

The full bill text is available here