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Pallone’s Bill to Support Advanced and Continuous Pharmaceutical Manufacturing Passes House

October 19, 2021
Press Release
Legislation Will Support Centers of Excellence at Universities Across the Country, Rutgers Already Playing Key Role

Washington, DC – Congressman Frank Pallone, Jr. (NJ-06)’s bipartisan bill to improve drug quality, reduce drug shortages, and make pharmaceutical production more efficient passed the U.S. House of Representatives today. Pallone’s National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act would allow the Food and Drug Administration (FDA) to partner with universities across the country with experience in these technologies to improve pharmaceutical production. The bill would designate certain universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, allowing them to work with FDA and industry to further develop and implement advanced and continuous manufacturing technology. The bill would also authorize $100 million in funding to support the effort. Pallone spoke in favor of the bill on the House floor.

 

Continuous manufacturing is an emerging technology whereby a finished product is produced in a continuous stream, making it more efficient than the current “batch” model that can be slow and may be subject to the risk of defects or errors during the manufacturing process. The pioneering 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 production sites to be located in or closer to the United States, reducing the need for transcontinental shipping. 

 

“The COVID-19 pandemic reinforced the need to reduce drug shortages ensuring critical medicines are available when needed and to prioritize efforts that could help bring drug manufacturing back to the United States. During the initial stages of the pandemic in New Jersey, I heard from health providers in my district about their inability to access commonly used and critically needed medication, including medication necessary for the use of ventilators, due to surges in demand,” said Congressman Pallone. “House passage of my bill brings us one step closer to expanding advanced and continuous manufacturing technology in the United States, to help improve drug quality, mitigate drug shortages, and create an environment that would encourage drug manufacturers to bring jobs back home. I am proud that Rutgers University is already playing a key role in the development of continuous manufacturing techniques that I hope will result in safer, cheaper, and more accessible medicine.”

“Our appreciation for Congressman Pallone’s commitment to keeping New Jersey on the cutting edge of pharmaceutical manufacturing and supporting the technology developed at Rutgers that will restore our position as the medicine cabinet to the world cannot be overstated,” said Jonathan Holloway, President of Rutgers, The State University of New Jersey. “His leadership will help make New Jersey a better place to live, work and raise a family.”

In 2018, Pallone toured the Center for Structured Organic Particulate Systems (C-SPOPS) at Rutgers University with then-FDA Commissioner Scott Gottlieb. The university center has played a leading role in the advancement of continuous manufacturing technology. Rutgers’ C-SOPS has been in place for over a decade and has designed and implemented continuous manufacturing methods for powder-based pharmaceutical products. The center includes a two-story, state-of-the-art lab including a full-scale production line built with funding from National Science Foundation and industry. The center is working side-by-side with industry to integrate continuous manufacturing into commercial production. In addition, the lab provides opportunities for students to participate in projects that will prepare them for careers as industry leaders of the future.