Sens. Rubio, Coons introduce Agility in Manufacturing Preparedness Act to bolster domestic biopharmaceutical manufacturing

A combined legislative effort from U.S. Sens. Marco Rubio (R-FL) and Chris Coons (D-DE) brought the Agility in Manufacturing Preparedness Act (S.3553) to the Senate this week, offering a proposal of how to improve domestic biopharmaceutical manufacturing capabilities for public health threats.

“America needs to be able to make things again, especially medicine,” Rubio said. “My new bill will help bring that back.”

Specifically, the bill would require the public-private partnership National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to evaluate the current capacity and vulnerabilities of biopharmaceutical manufacturing in the United States, alongside the U.S. Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA). Domestic capacity at HHS and its current adaptability to threats would be reviewed. Recommendations for developing, demonstrating, deploying, and advancing new domestic biopharmaceutical manufacturing technologies would be drafted to address gaps in those current capabilities.

“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 senators claimed that the legislation would closely align federal technologies with private-sector capabilities. Further, it would push identification of other opportunities and priorities to improve U.S. public health, medical preparedness, and response capabilities, along with domestic biopharmaceutical manufacturing capabilities at large.