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Pallone and Guthrie Introduce Legislation to Support Continuous Pharmaceutical Manufacturing

Oct 28, 2019
Press Release

Today, Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Rep. Brett Guthrie (R-KY) introduced H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019.  The bipartisan legislation would allow the Food and Drug Administration (FDA) to partner with universities across the country to designate them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing.  The designated universities would work with FDA and industry to further develop and implement continuous manufacturing technology and authorizes $80 million in funding to support the effort.

“Continuous pharmaceutical manufacturing is the future of medicine,” Pallone said. “This bipartisan legislation will foster the development of the emerging technology by expanding opportunities for FDA to partner with universities across the country that are leading these efforts, including Rutgers University in my congressional district.  These partnerships will play a key role in creating a framework for the widescale adoption of this pioneering technology, which I hope will limit drug shortages in the future and help spur a new generation of 21st century manufacturing jobs right here at home.”

“The United States is home to cutting-edge medical and pharmaceutical innovation,” said Guthrie. “I was glad to work with Chairman Pallone on this bill that will allow the FDA to partner with continuous pharmaceutical manufacturing centers to make drug manufacturing more efficient, so we can continue to see advances in medical technology and decrease drug shortages.”

Drug manufacturing has changed very little in 50 years, with most companies still using “batch” manufacturing techniques that can be inefficient, slow and may be subject to the risk of defects or errors during the manufacturing process.  Continuous manufacturing is an emerging technology whereby a finished product is produced in a continuous stream.  This technology allows product quality to be precisely controlled, reduces challenges in scaling up production, can more readily produce ranges of drug strengths and doses and requires less physical space.  This could allow more production sites to be located in the U.S, creating new jobs, reducing the need for transcontinental shipping and helping prevent future drug shortages.

Last year, Pallone visited Rutgers University with then FDA Commissioner Scott Gottlieb, M.D to tour the campus’ Center for Structured Organic Particulate Systems.  The university center has played a leading role in the advancement of continuous manufacturing technology. 

Pallone authored legislation that was signed into law as a part of 21st Century Cures Act authorizing FDA to issue grants to institutions of higher education and nonprofit organizations to study and make recommendations regarding improvements to the process of continuous manufacturing of drugs and biologics.

H.R. 4866 bill text available HERE.