Spanberger Calls for Boost In Domestic Prescription Drug Manufacturing, Lower Costs for Consumers

The Congresswoman Has Long Been a Leading Proponent of Strengthening Continuous Pharmaceutical Manufacturing in Virginia

HENRICO, V.A. — Following new investments in manufacturing research authorized as part of the CHIPS and Science Act, U.S. Representative Abigail Spanberger today called for increased investments to strengthen continuous prescription drug manufacturing, bolster the supply of essential generic medicines, and prevent future prescription drug shortages in the United States.

Continuous manufacturing is an emerging technology whereby a finished product is produced in a continuous stream which reduces economic inefficiencies by allowing chemical engineers to produce exactly as much supply of a product as needed to meet market demand — making it more efficient than the current “batch” model. The technology allows chemical engineers to precisely control product quality, quickly identify any production problems, and minimize waste and discharge.

The bipartisan CHIPS and Science Act — which was signed into law in August — authorizes the National Science Foundation (NSF) to fund research into manufacturing technologies that include real-time process controls, which are a critical component of the continuous manufacturing of pharmaceuticals. Virginia research institutions, like Virginia Commonwealth University, stand to benefit from this new funding for ongoing continuous manufacturing research.

In a letter to NSF Director Sethuraman Panchanathan, Spanberger called on the NSF to support research to use its new authority under the CHIPS and Science Act to improve the resiliency of domestic pharmaceutical supply chains and prevent future shortages of generic prescription drugs. Additionally, Spanberger highlighted her longstanding work to increase federal support for continuous manufacturing.

“Our country’s historic underinvestment in pharmaceutical manufacturing research has contributed to persistent shortages of essential generic drugs and our reliance on foreign suppliers for those drugs and the ingredients necessary to make them,” wrote Spanberger. “There is bipartisan concern about the public health and national security vulnerabilities caused by our country’s reliance on outdated batch manufacturing techniques for essential generic medicines.”

She continued, “I believe NSF can support continuous manufacturing research through the new CHIPS Act language authorizing research into real-time process controls. I encourage NSF to use its new authority to support research that will improve the resiliency of domestic pharmaceutical supply chains and ensure our healthcare system has a stable supply of essential generic medicines.”

In June 2021, Spanberger introduced the bipartisan Continuous Manufacturing Research Act that would allow the NSF to award grants for research into advanced pharmaceutical manufacturing — including continuous manufacturing research. Later that year, the U.S. House unanimously passed language based on the Spanberger-led legislation as part of the National Science Foundation for the Future Act.

Click here to read Spanberger’s letter, and the full letter text is below.

Dear Director Panchanathan,

I write as a leading advocate for the National Science Foundation (NSF)’s leadership in advanced manufacturing research that strengthens our national security and reshapes strategic and essential industries. I was proud to introduce the bipartisan Continuous Manufacturing Research Act of 2021 (H.R. 3851) to authorize NSF funding for cutting-edge pharmaceutical manufacturing technologies to address our healthcare system’s persistent shortages of essential generic medicines.

Section 10358 of the CHIPS and Science Act of 2022 (P.L. 117-167) authorizes NSF to fund research into manufacturing technologies that include real-time process controls, which are a crucial component in the continuous manufacturing techniques H.R. 3851 aimed to support. Therefore, I encourage NSF to take full advantage of its new CHIPS Act authority and support research into pharmaceutical manufacturing techniques that allow for real-time process controls, improve the resiliency of domestic pharmaceutical supply chains, and bolster our country’s readiness for future public health emergencies.

Our country’s historic underinvestment in pharmaceutical manufacturing research has contributed to persistent shortages of essential generic drugs and our reliance on foreign suppliers for those drugs and the ingredients necessary to make them. In the U.S., most generic drugs are manufactured in a “batch production” process that hasn’t changed since the 1950s. In this model, engineers process large “batches” of material at each stage of the production process. Engineers can only undertake quality control after a batch is finished. If the quality is not satisfactory, the entire batch must be discarded, and the process begins again from the start.

By comparison, a continuous manufacturing model is an emerging technology whereby a finished pharmaceutical is produced in a steady stream, much like a traditional assembly line. This approach allows chemical engineers to precisely control product quality, quickly identify any production problems, and minimize waste and discharge. Notably, continuous manufacturing reduces economic inefficiencies by allowing chemical engineers to produce exactly as much supply of a product as needed to meet market demand, a level of precision that is often impossible with batch processing. Continuous manufacturing also reduces production costs for the manufacturer, increasing the margin on a generic drug and improving the incentive to invest in the sector.

There is bipartisan concern about the public health and national security vulnerabilities caused by our country’s reliance on outdated batch manufacturing techniques for essential generic medicines. That’s why a bipartisan group of lawmakers came together across party lines to introduce the Continuous Manufacturing Research Act (H.R. 3851). Last year, I was proud to see language based on my bill included in the bipartisan National Science Foundation for the Future Act that passed the U.S. House of Representatives by voice vote.

I believe NSF can support continuous manufacturing research through the new CHIPS Act language authorizing research into real-time process controls. I encourage NSF to use its new authority to support research that will improve the resiliency of domestic pharmaceutical supply chains and ensure our healthcare system has a stable supply of essential generic medicines. I hope that NSF will collaborate with other initiatives at the Department of Commerce, the Food and Drug Administration, and the Department of Health and Human Services to maximize the impact of its awards. If NSF feels it needs new authorities or direction from Congress, I stand ready to assist.

Thank you for being so committed to advancing science and knowledge that will improve our country’s public health and national security. I look forward to working with you on these important issues.

— 

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