Pallone’s Bill to Support Continuous Pharmaceutical Manufacturing Passes House
Washington, DC – Congressman Frank Pallone, Jr. (NJ-06) announced that his 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 Continuous Pharmaceutical Manufacturing Act of 2019 would allow the Food and Drug Administration (FDA) to partner with universities across the country, such as Rutgers University, to advance pharmaceutical production. The bill would designate certain universities as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, allowing them to work with FDA and industry to further develop and implement continuous manufacturing technology. The bill would also authorize $80 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 closer to the U.S., reducing the need for transcontinental shipping.
“The COVID-19 pandemic has 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 outbreak 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,” Congressman Pallone said. “My bill will help expand 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 is proud to be at the nexus of innovative technological advancements in pharmaceutical production,” said Rutgers-New Brunswick Chancellor Chris Molloy. “The Center for Structured Organic Particulate Systems (C-SOPS), headquartered at Rutgers and led by Chemical and Biochemical Engineering Distinguished Professor Fernando Muzzio, brings together a cross-disciplinary team of researchers from major universities to improve pharmaceutical manufacturing. Having been in the pharmaceutical private sector for many years, as well as having served as Dean of the Ernest Mario School of Pharmacy at Rutgers, I can personally attest to how important this work is, especially in the midst of a worldwide pandemic. We remain grateful to Chairman Pallone for continuing to champion this important research initiative.”
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.