National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2020

Floor Speech

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Mr. PALLONE. Mr. Speaker, I rise in support of H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act.

Continuous pharmaceutical manufacturing is the future of medicine. This bipartisan bill, which I introduced with Representative Guthrie last year, will foster the development of continuous manufacturing technology, a more nimble and efficient mode of pharmaceutical production. It does this by expanding opportunities for the Food and Drug Administration (FDA) to partner with universities across the country that are leading these efforts and create Centers of Excellence for Continuous Pharmaceutical Manufacturing. The partnerships created by the legislation will help develop continuous manufacturing technology and standardization, develop a continuous manufacturing workforce here in the United States, and make recommendations for how FDA, industry, and others can expand the use of continuous manufacturing for drugs and biologics.

The COVID-19 pandemic has demonstrated how the outdated batch manufacturing process adds to the potential for supply chain issues. 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. H.R. 4866 will help prevent supply chain interruptions like these by increasing domestic manufacturing and allowing manufacturers to more quickly adjust to sudden shifts in demand.

As Dr. Janet Woodcock, the Director for the Center for Drug Evaluation and Research at FDA told the Energy and Commerce Subcommittee on Health last year, advance manufacturing technologies-- such as continuous manufacturing--can help to ``reduce the Nation's dependence on foreign sources of [active pharmaceutical ingredients], increase the resilience of our domestic manufacturing base, and reduce quality issues that trigger drug shortages or recalls.''

In other words, by passing this bill and expanding continuous manufacturing technology in the United States, we can avoid future drug shortages and other supply chain interruptions, while bringing jobs back to the United States. This will help those on the frontlines battling COVID-19 and the patients who are depending on them.

I want to thank Representative Guthrie for working with me on this bill and demonstrating the collegial and bipartisan spirit of the Energy and Commerce Committee. I urge all members to support this important legislation.

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