The executive order will launch a National Biotechnology and Biomanufacturing Initiative that will accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors, including health, agriculture, and energy, the White House announced.
About Biden’s biomanufacturing executive order
The National Biotechnology and Biomanufacturing Initiative will drive advances in biomanufacturing that substitute fragile supply chains abroad with strong supply chains at home, anchored by well-paying jobs in communities all across America.
The executive order takes several steps including:
- coordinating federal R&D funding,
- streamlining regulation to facilitate development,
- establishing a data initiative to support research,
- expanding market opportunities for bioenergy and biobased products and services, and
- supporting the training of biotech specialists.
“With biotechnology, we can program microbes to make specialty chemicals and compounds, a process called ‘biomanufacturing,'” the White House fact sheet states. “These advances have led industry to embrace biomanufacturing—as an alternative to petrochemical-based production—to make things like plastics, fuels, materials, and medicines.”
According to the White House, the initiative aims to:
- Grow domestic biomanufacturing capacity
- Expand market opportunities for bio-based products
- Drive R&D to solve our greatest challenges
- Improve access to quality federal data
- Train a diverse skilled workforce
- Streamline regulations for biotechnology products
- Advance biosafety and biosecurity to reduce risk
- Protect the U.S. biotechnology ecosystem
- Build a thriving, secure global bioeconomy with partners and allies
US needs to keep up with the world on biotech
The executive order promotes domestic biomanufacturing capacity—a priority Biotechnology Innovation Organization (BIO) President and CEO Dr. Michelle McMurry-Heath emphasized to the President’s Council of Advisors on Science and Technology in November.
The White House stated that the global industry is on the cusp of an industrial revolution powered by biotechnology.
Other countries are positioning themselves to become the world’s resource for biotechnology solutions and products.
The White House also argues the US has depended too much on foreign resources and bioproduction. The offshoring of vital industries, including biotechnology, in the past jeopardizes the capacity to obtain materials like essential chemicals and active medicinal components.
“By responsibly harnessing the full potential of biotechnology and biomanufacturing, we will be able to realize the potential of biology that can make almost anything that we use in our day-to-day lives, from medicines to fuels to plastics, and continue to drive U.S. innovation into economic and societal success,” the White House concludes.
Federal agencies should step up oversight
The order calls for agencies including the U.S. Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA) to identify areas of ambiguity, gaps, or uncertainties in the federal regulatory system for biotechnology.
These agencies are required to submit a plan for implementing reforms, including identifying regulations and guidance documents that need to be “updated, streamlined or clarified.”
“Today’s action is going to ensure that America leads the world in biotechnology and biomanufacturing, creating jobs, reducing prices, strengthening supply chains so we don’t have to rely on anywhere else in the world,” Biden said.
“We commend the administration for launching this initiative, particularly the actions to streamline regulatory regulations for biotechnology products, expand market opportunities for biobased products, work for international alignment of regulatory standards, and invest in training and education pathways to ensure an adequate, diverse biotech workforce,” BIO’s Dr. Michelle McMurry-Heath said yesterday.
Biden to appoint new director of ARPA-H
In addition, Biden announced on Monday that he intends to “appoint Dr. Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans.”
Dr. Wegrzyn is a scientist with experience working for the Defense Advanced Research Projects Agency (DARPA) and Intelligence Advanced Research Projects Activity (IARPA), two organizations that served as the inspiration for ARPA-H. She will be in charge of overseeing the agency’s developing research portfolio and associated budget.
The new agency is intended to enable medical advances by following the DARPA model, which supports “high-risk, high-reward research,” according to Nature.
The White House will also hold a summit on Wednesday to discuss the executive order in more detail.
During the summit, “cabinet agencies will announce a wide range of new investments and resources that will allow the United States to harness the full potential of biotechnology and biomanufacturing and advance the President’s Executive Order.”