WASHINGTON, DC - Today, Congressman David Rouzer (R-NC-07) joined Representative Chrissy Houlahan (D-PA-06) in introducing the Biomanufacturing Excellence Act, which would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing. Companion legislation is being led in the U.S. Senate by Senators Chris Coons (D-Del) and Ted Budd (R-NC).
Biotechnology will shape how the United States defends itself, secures its food supply, and cures life-threatening diseases. The National Security Commission on Emerging Biotechnology (NSCEB) warned that without rapid and significant investment, the U.S. will fall behind its global competitors, specifically China. China’s share of global pharmaceutical output has surged from about 5% in 2002 to nearly 25% in 2019. This legislation reinvests in domestic biopharmaceutical manufacturing, reducing dependence on unreliable foreign supply chains, expanding access to cutting-edge medicines, and supporting high-quality American jobs.
“Biotechnology is rapidly reshaping national defense, health security, and our economy’s resilience. As home to one of the strongest biotech and biomanufacturing ecosystems in the country, North Carolina has demonstrated how innovation can strengthen America’s ability to develop and produce life-saving medicines,” said Congressman Rouzer. “The Biomanufacturing Excellence Act reaffirms our commitment to expanding that capacity here at home. By supporting public-private collaboration and growing our domestic manufacturing base, this legislation ensures the United States can remain competitive, reduce reliance on foreign supply chains, and equip the next generation of biotechnology leaders to drive our nation forward.”
The Biomanufacturing Excellence Act would establish a public-private center dedicated to advancing biopharmaceutical manufacturing – a key recommendation from the National Security Commission on Emerging Biotechnology (NSCEB) report.
Specifically, the National Biopharmaceutical Manufacturing Center of Excellence Act would:
- Unite industry professionals with academic researchers to conduct collaborative research on new technology for scaling biopharmaceutical manufacturing.
- Host a facility that replicates industrial manufacturing conditions and complies with FDA Current Good Manufacturing Practice (CGMP) regulations, where innovators would develop and test new manufacturing processes.
- Identify challenges and opportunities for scaling biopharmaceutical manufacturing, especially for products important to U.S. national security, public health, and economic security.
- Train tomorrow’s biopharmaceutical manufacturing workforce by partnering with educational, industry, and community leaders to bolster biotechnology talent.
"Southeastern Pennsylvania has a storied history as a global leader in the life sciences. Yet too many of our breakthroughs struggle to reach patients and markets because we lack the biomanufacturing capacity to scale and commercialize them. That gap threatens jobs, our regional competitiveness, and our access to medicines, applications, solutions and treatments Americans and our nation need. Our bipartisan Biomanufacturing Excellence Act tackles this head-on by creating a national Center of Excellence to drive innovation in biopharmaceutical manufacturing. The bill would cut costs, speed production, and grow our biotech workforce here in our Commonwealth. As competitors like the Chinese Communist Party race to dominate this space, we cannot afford to fall behind,” said Representative Chrissy Houlahan.
“Not only is biomanufacturing a key pillar of America's and North Carolina’s innovation economy, it has the potential to transform major aspects of everyday life. We must foster this critical technology and continue to lead the world in enabling life-saving medical breakthroughs, fortifying our critical supply chains, and creating good-paying, high-skilled jobs. I am proud to partner with Senator Coons to help build on the public-private partnerships that have unlocked significant economic potential and unleashed next-generation technology,” said Senator Budd.
“Delaware and innovation have always gone hand in hand,” said Senator Coons. “The extraordinary biomedical research that happens in the First State has grown our economy, turned start-ups into industry leaders, and saved lives around the world. China is surging ahead in biotechnology, putting our national security, economy, and health at risk. This bipartisan bill will ensure the United States continues to lead the world in biotech manufacturing, protecting Americans’ security and our health.”
The bill is endorsed by the National Security Commission on Emerging Biotechnology (NSCEB), the Biotechnology Innovation Organization, the Information Technology and Innovation Foundation (ITIF), NCLifeSci and NCBiotech, and the American Alliance for Biomanufacturing.
“The creation of a National Biopharmaceutical Manufacturing Center of Excellence is pivotal to advancing US leadership in bioprocess innovation, supply chain resiliency, and workforce competitiveness. We greatly appreciate Congressional leadership in recognizing the importance of biomanufacturing to national and economic security. For over four decades, North Carolina has created an integrated ecosystem focused on a steadfast commitment to life sciences manufacturing, establishing the state as a global leader with over $17 Billion of investment and 7,500 jobs announced since 2021. This success is built on a community of partners that work to seamlessly integrate world-class institutions of innovation with over 150 life sciences manufacturing companies, forming a uniquely dense hub for accelerating the translation of cutting-edge biomanufacturing innovations to scaled commercial outputs,” a joint statement from NCLifeSci and NCBiotech reads.
The full text of the bill is available here and a one-pager on the bill is available here.
