Pallone's Bill to Support Continuous Pharmaceutical Manufacturing Advances in House

Press Release

Congressman Frank Pallone, Jr. (NJ-06) announced that his bipartisan bill to improve drug quality, reduce drug shortages, and make pharmaceutical production more efficient advanced in 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 advance 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.

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. "My bill will help expand advanced and continuous manufacturing technology in the United States, so we can avoid future drug shortages and other supply chain interruptions, while bringing jobs back to the United States. 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."

"Rutgers-New Brunswick is grateful to Chairman Pallone for his commitment and vision. We are excited that his legislation will allow us to continue to lead the way in advancing pharmaceutical manufacturing, and in improving New Jersey's and the nation's quality of life through our research," said Rutgers University--New Brunswick Chancellor-Provost Francine Conway.

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.

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