Bipartisan Group of Lawmakers Calls for Inclusion of the Congresswoman’s “Continuous Manufacturing Research Act” in the Final Version of the Conferenced USICA-COMPETES Legislation

WASHINGTON, D.C. — U.S. Rep. Abigail Spanberger today led a bipartisan effort calling on Congress to strengthen domestic production of essential drugs amid ongoing prescription drug shortages.

According to a recent report from 60 Minutes, U.S. hospitals are facing routine drug shortages, including “nearly 300 essential drugs” in short supply on most days. Even during these shortages marked by high demand, pharmaceutical companies have regularly stopped producing key generic drugs — simply because these medicines do not generate enough profit. Meanwhile, the United States continues to underinvest in research that can improve our outdated generic drug manufacturing techniques, lower drug costs, and reduce shortages.

In a letter sent to the leaders of the U.S. House Science, Space, and Technology Committee; U.S. Senate Commerce, Science, and Transportation Committee; and U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, Spanberger and four of her colleagues called for the Continuous Manufacturing Research Act to be included in the final version of the conferenced USICA-COMPETES legislation.  

The Continuous Manufacturing Research Act would allow the National Science Foundation (NSF) to award grants for research into advanced pharmaceutical manufacturing — including continuous manufacturing research. These investments would provide much-needed assistance to continuous manufacturing programs by supporting advanced manufacturing research, workforce development, and more. Additionally, the bipartisan bill would authorize grant funding for students pursuing a degree in pharmaceutical engineering.

“Our reliance on outdated batch manufacturing techniques for essential generic medicines increases the costs of production, puts us at a disadvantage against international competitors, and makes quality failures at plants more likely,” said Spanberger and her colleagues. “Unfortunately, the low prices and thin margins manufacturers get for essential generical medicines have stymied private investment in expanding and developing modern production techniques like continuous manufacturing.”

They continued, “Investments in ensuring patients and providers have access to the drugs they need to stay healthy are commonsense and have strong bipartisan support. We urge you include the key provisions of the Continuous Manufacturing Research Act in the final conferenced agreement, consistent with what already passed the U.S. House.”

U.S. Representatives David B. McKinley (R-WV-01), Anthony Gonzalez (R-OH-16), Peter Meijer (R-MI-03), and Deborah K. Ross (D-NC-02) — all of whom are co-leads of the Continuous Manufacturing Research Act — joined Spanberger’s letter.

Click here to read the letter, and the full letter text is also below.

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Dear Chairwoman Cantwell, Ranking Member Wicker, Chairwoman Murray, Ranking Member Burr, Chairwoman Johnson, and Ranking Member Lucas,

As you weigh the many different priorities to be included in the negotiated COMPETES Act, we urge you to include the provisions of the bipartisan Continuous Manufacturing Research Act (H.R. 3851) that authorizes the National Science Foundation to invest in research on advanced pharmaceutical manufacturing techniques that would improve our domestic production of generic medicines, reduce drug shortages, and restore America’s position as a global leader in health care innovation. HR 3851 was included in the National Science Foundation for the Future Act which overwhelmingly passed the House in June 2021.

Shortages of essential generic drugs have been a persistent problem in our health care system for years. Most generic drugs are cheap to make and sell, meaning there is little margin for manufacturers to invest in modern manufacturing technology or redundant operations. The slightest delay or stoppage in manufacturing at one plant can result in nationwide drug shortages that frustrate providers, compromise patients’ access to care, and expose consumers to price gouging by unscrupulous manufacturers. Additionally, our reliance on foreign suppliers located in China and other hostile nations for essential medicines and the ingredients necessary to make those medicines is a national security risk. 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 for chemical engineers to precisely control product quality, quickly identify any production problems, and minimize waste and discharge. It also reduces production costs for the manufacturer, increasing the margin on a generic drug and improving the incentive to invest in the sector.

Our reliance on outdated batch manufacturing techniques for essential generic medicines increases the costs of production, puts us at a disadvantage against international competitors, and makes quality failures at plants more likely. Unfortunately, the low prices and thin margins manufacturers get for essential generical medicines have stymied private investment in expanding and developing modern production techniques like continuous manufacturing.

Last year, we were proud to introduce the bipartisan Continuous Manufacturing Research Act (H.R. 3851) to authorize the National Science Foundation to invest in research on advanced pharmaceutical manufacturing techniques like continuous manufacturing. These investments would provide much-needed assistance to continuous manufacturing programs by supporting research, workforce development, and more. Additionally, the bill would authorize grant funding for students pursuing a degree in pharmaceutical engineering.  

Investments in ensuring patients and providers have access to the drugs they need to stay healthy are commonsense and have strong bipartisan support. We urge you include the key provisions of the Continuous Manufacturing Research Act in the final conferenced agreement, consistent with what already passed the U.S. House.

Thank you very much for your consideration.

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