For the United States, the economic, societal, and national security benefits of the life sciences are vast. The U.S. bioeconomy – the part of the economy driven by the life sciences and biotech, and enabled by engineering, computing, and information science – is valued at over $950 billion. Life sciences research leads to cleaner crops through pollution-free fertilizers, and access to life-saving vaccines, like those mRNA vaccines that helped counter the devastating impacts of COVID-19. And industries built on the life sciences create good-paying jobs across the country.
The 118th Congress can adopt policy to help drive U.S. biotech and biomanufacturing to grow regional prosperity, deliver on conservation goals, and improve U.S. competitiveness and resilience. Here are some ideas.
Advancing the U.S. Bioeconomy to Create Jobs and Bolster Competitiveness. Many provisions in the bipartisan CHIPS and Science Act are intended to enable the bioeconomy. Implementation should focus on three areas: cutting-edge R&D, fundamental and publicly available tools, and biomanufacturing. To further support fundamental research, Congress could direct the National Institutes of Health (NIH) to aim to maximize returns on its massive R&D budget by piloting novel funding mechanisms with evaluation through randomized control trials, funding more high-risk high-reward research, and dedicating more funding to early-career researchers. Congress could also establish a Plant Genome Research Institute (PGRI) that would drive plant genomics research and centralize federal government activities, helping to promote crop innovation and enable a diversified, localized, and resilient food system. And to ensure all Americans benefit fully, actions should be taken to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases.
To promote U.S. bioindustrial manufacturing scale-up and commercialization, Congress could authorize a Bio for America Program Office at the National Institute of Standards and Technology. With appropriations, the office would house a suite of initiatives:
- A Bioindustrial Production Consortium that coordinates precompetitive efforts helping to address the measurements, tools, and standards needed for advancing both research and commercial products in the bioindustrial production space, and that collaborates with BioMADE, industry, government scientists, and other stakeholders.
- BAPO Ventures, which would seed a nonprofit partnership manager to launch a U.S. Bioindustrial Production Investment Portfolio to crowd-in additional capital from non-federal government sources and makes calculated investments in early-stage, domestic bioindustrial production companies that demonstrate credible pathways to product commercialization.
- The Bioindustrial Production Scale-up Infrastructure Group, which as an initial step would work with both the interagency and non-federal government partners to conduct a comprehensive analysis of the U.S. bioindustrial production pilot- and intermediate-scale infrastructure landscape in order to develop a precision strategy for moving forward on domestic bioindustrial production scale-up capacity.
- A Bioindustrial Production Loan Program Office that relies on partners such as the U.S. Small Business Administration to help it provide debt financing for techno-economically sound, domestic demonstration- or commercial-scale bioindustrial production infrastructure projects.
Importantly, Congress can help prepare and invite more Americans into skilled jobs that support the bioeconomy, building a better future for Americans in all 50 states – including people of color, people with disabilities, and people from economically disadvantaged backgrounds – by funding modernized biology education, establishing world-class entrepreneurial hubs for biotechnology in non-traditional regions of the country, and supporting equitable access to industry-recognized certificates and work-based training.
Biotech can also be leveraged to fast-track our nation’s capability to deliver on conservation goals, remediate contaminated habitats, and detect dangerous environmental toxins and pathogens. To that end, Congress could establish a national center to achieve several important goals:
- Provide competitive grant funding across three key tracks – carbon capture, bioremediation, biomonitoring – to catalyze comprehensive environmental biotechnology research
- House a bioethics council to develop and update guidelines for safe, equitable environmental biotechnology use
- Manage testbeds to efficiently prototype environmental biotechnology solutions; and
- Facilitate public-private partnerships to help transition solutions from prototype to commercial scale.
Safeguarding Americans Against Biological Threats. The human and economic toll of COVID-19 has shown the need to be better prepared for future pandemics and epidemics. And yet, there is currently little to no economic incentive for pharmaceutical companies to engage in vaccine research for infectious diseases that have not, and yet could, cause a pandemic. To address this market failure, the U.S. should incentivize vaccine development for priority emerging infectious diseases through federal financing. Specifically, Congress should authorize and appropriate $10 billion to the Biomedical Advanced Research and Development Authority (BARDA) over 10 years to create an investment fund that would:
- Leverage demand-pull mechanisms to purchase vaccines in bulk during future outbreaks and promote innovation in vaccine R&D
- Support manufacturing and distribution facilities
- Provide limited government guarantees, equities, and securities to investors in vaccine development.
Masks, especially high quality respirators, are disease-agnostic tools that can help reduce infections from respiratory diseases like the flu virus and RSV. In turn, this can reduce the burden on doctors and hospitals, and avoid additional healthcare. To that end, the mail delivery system used to distribute COVID-19 diagnostic tests should be augmented by the addition of a masks via mail program. The COVID-19 test mailing program should be restarted and expanded to include an option for ordering one box of 10 free N95 masks every quarter, for those Americans who wish to participate. Additionally, rotating face-mask inventory from the Strategic National Stockpile in a “first in, first out” method will prevent masks from being stored past their recommended shelf life, and promote continual replenishment of the U.S.’s stockpile. The recent National Strategy for a Resilient Public Health Supply Chain, as well as the bipartisan PPE in America Act (H.R.1436) and the bipartisan PREVENT Pandemics Act (S.3799), all advocate for a rotating stock system; however, steps must be taken to better operationalize its implementation and instate a timeline. Congress should authorize the Administration for Strategic Preparedness and Response to grant the HHS Coordination Operations and Response Element key management and distribution responsibilities for critical diagnostic and preventative measures like tests and masks.
The impact of the COVID-19 pandemic was significantly worsened by the presence of diseases that persist at relatively stable case numbers within a particular region. Additional infections paired with COVID-19 infections can lead to lower survival rates and longer hospital stays, creating a drain on resources as well as higher morbidity and mortality effects. Congress should thus authorize an initiative within the Centers for Disease Control and Prevention that enhances the reporting and tracking of regional diseases and helps reduce the data gap that prevents actions and responses to countering circulating diseases. The initiative could be incorporated into S. 3814, the bipartisan Modernizing Biosurveillance Capabilities and Epidemic Forecasting Act.
Finally, the bipartisan Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) will expire in 2023. This law contains several integral provisions for national health security, public health preparedness, biosurveillance, and emergency medical countermeasures, as well as authorizations for BARDA and the Assistant Secretary for Preparedness and Response (ASPR). Congress should re-authorize PAHPAIA, as it forms the bedrock of America’s pandemic preparedness architecture, and consider expanding its purview to address aspects of other U.S. challenges such as wildfires and antimicrobial resistance.
Bioeconomy in CHIPS and Science. There are many provisions critical to the U.S. bioeconomy in the CHIPS and Science Law, which Congress should ensure receive robust appropriations. These include:
- Coordinating and strategy activities in Title IV, focused on Bioeconomy Research and Development;
- Title III, Subtitle G, National Science Foundation Directorate for Technology, Innovation, and Partnerships. The directorate is authorized at $3.4 billion overall in FY 2024. The list of critical technologies the new directorate is intended to advance (Section 10387) includes biotechnology, medical technology, genomics, and synthetic biology, all relevant to the bioeconomy. The directorate also funds the Regional Innovation Engines program promoting biotech partnerships and commercialization efforts across the U.S. in biotech.
- Title II, Section 10221, which directs the National Institute of Standards and Technology to conduct an array of activities in engineering biology and biometrology.
- Title I, Section 10103, Department of Energy (DOE) Biological and Environmental Research (authorized at $947 million in FY 2024), which funds an array of fundamental research in the biosciences.
- Title I, Section 10112, Office of Science Emerging Biological Threat Preparedness Research Initiative (authorized at $50 million in FY 2024), which establishes a cross-cutting program to leverage DOE analytical resources and tools, user facilities, and advanced computational and networking capabilities to support efforts that prevent, prepare for, predict, and respond to biological threats to national security, including infectious diseases.
Congress should provide robust appropriations to all activities, as close to the CHIPS authorizations as possible, to ensure a dynamic and innovative bioeconomy sector.
Bioproduct Pilot Program. The National Institute of Food and Agriculture’s (NIFA) Bioproduct Pilot Program (created in the Infrastructure Investment and Jobs Act, Sec. 70501) is intended to increase economic activity in rural areas of the U.S. while also lowering commercialization risks associated with bringing biobased products to market. The program aims to study the benefits of using materials derived from covered agricultural commodities for manufacture of construction and consumer products. The program’s work also enables the development of a more circular economy, where finite resources are not just extracted and consumed but also regenerated in a sustainable manner. Adopting a more circular economy ensures that wealth and other economic benefits in the form of jobs and other opportunities are created, and stay in, rural communities, while learnings can be shared throughout the U.S. innovation ecosystem.
A total of up to $5 million is available for the program for each of FY 2022 and FY 2023. The availability of funds for the program should be extended through FY 2028, with yearly increases to a level above $5 million per year according to the requests of NIFA/the program team.
Scaling and Regionalizing Networked Bioindustrial Manufacturing. The 2023 NDAA (Division A, Section 215) directs the Secretary of Defense to establish and expand a network of manufacturing innovation institutes and intermediate scale facilities for R&D, piloting, and scaling of innovative bioindustrial manufacturing processes and products. Support for these activities is critical to ensure the industrial base can leverage bioindustrial manufacturing processes for the production of chemicals, materials, and other products necessary to support national security and secure fragile supply chains. Congress should provide $500 million in appropriations across national security bioeconomy activities including $300 million for biomanufacturing innovation institutes, in accord with the NDAA.
Countering Global Malnutrition to Enhance U.S. Security. Due to the COVID-19 pandemic, environmental impacts, and conflicts like the war in Ukraine, global rates of malnutrition are at eight percent and are forecast to become even worse. Providing life-saving treatment around the world serves a core American value of humanitarianism, and a priority for U.S. national security – the newly released National Security Strategy dedicates an entire section to food insecurity.
In 2021 legislation, Congress directed USAID to advance programs to prevent and treat malnutrition around the world and develop a Global Nutrition Coordination Plan. That legislation also directed USAID to create the Nutrition Leadership Council, which can help elevate nutrition programs across U.S. global health interventions and foster collaboration with other sectors, development agencies, partner governments, and local actors. These are important steps to create a centralized food security program with harmonized funding – a system to deploy a more effective response to end global malnutrition and improve U.S. national security.
Congress should work with the Administration to begin scaling up global malnutrition assistance in FY 2024, in accord with the 2021 legislation.
Supporting the U.S. Emergency Response Workforce. The National Disaster Medical System (NDMS) is an integral part of the United States’ pandemic and hazards preparedness and response infrastructure. NDMS has a unique ability to coordinate and deliver emergency medical services to both federal and state, local, tribal, or territorial (SLTT) agencies. During the COVID-19 pandemic, NDMS deployed all across the country to provide training, medical care, coordinate medical supply delivery, and ensure effective communication. Additional appropriations would go toward hiring more personnel and bolstering in-person activities in the wake of COVID-19. Congress should ensure NDMS is funded up to FY 2024 request levels.
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