Executive Order Aims to Stimulate Innovation in Biotechnology and Biomanufacturing | Kilpatrick Townsend & Stockton LLP – JDSupra

Expanding on policies established by President Obama and President Trump to promote advances in biotechnology, President Biden signed Executive Order 14081, entitled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” on September 12, 2022. Noting that the COVID-19 pandemic “demonstrated the vital role of biotechnology and biomanufacturing in developing and producing life-saving diagnostics, therapeutics, and vaccines,” the Executive Order recites a number of goals with respect to biotechnology and biomanufacturing to benefit the United States and the global economy. The Executive Order also emphasizes that biotechnology and biomanufacturing not only impact the health industry, but also affect “climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”

Among other goals, the Executive Order seeks to increase Federal investment in key research and development (R&D); to expand domestic biomanufacturing production capacity and processes; to encourage the cooperation within the international biotechnology community; to increase efforts to accelerate the translation of basic research results into their practical use; to provide more opportunities, at all levels, for training in biotechnology and biomanufacturing; to provide more clarity to the current regulations that govern biotechnology and biomanufacturing; to develop systems and policy to expand and protect the U.S. bioeconomy (i.e., the economic activity derived from life sciences industries, products, services, and workforce); to increase the market for bioenergy and bio-based products; and to encourage sustainable biomass production and create climate-smart incentives for agricultural producers and forest landowners. Section 1 details each of the specific goals. In the subsequent sections, the Executive Order provides concrete steps to achieve these goals and includes specific timelines for analysis, reporting, and planning. A few of the goals and plans are described further below.

With respect to biotechnology and biomanufacturing R&D, Section 3 of the Executive Order taps the Secretary of Health and Human Services, the Secretary of Energy, the Secretary of Agriculture, the Secretary of Commerce, and the Director of the National Science Foundation (NSF) to prepare reports within 180 days of the Executive Order that detail how biotechnology, biomanufacturing, bioenergy, and bio-based products could be used to advance their industry (e.g, to achieve medical breakthroughs, to mitigate the impact of climate change, to improve food quality and nutrition, to protect against plant and animal pests and diseases, to strengthen the U.S. supply chain). Each report must identify the highest priority R&D needs, identify opportunities for collaboration between public and private entities, and recommendations to enhance biosafety and biosecurity. Based on the recommendations in these reports, the Director of the Office of Science and Technology Policy, coordinating with others, must develop an implementation plan. The Executive Order requires that a report be submitted within two years to identify the measures taken and resources allocated based on the implementation plan.

Section 5 of the Executive Order seeks to address the increased need for biomanufacturing. This particular goal may have been sparked, at least in part, by the supply chain issues experience with respect to COVID-19 diagnostic testing kits and vaccines. The Order requires that a strategy be developed to identify recommendations to expand U.S. manufacturing capacity for products in the “health, energy, agriculture, and industrial sectors.” The NSF, Department of Commerce, Department of Defense, and Department of Energy are all required to direct resources to create or expand infrastructure and programs to support biomanufacturing in the U.S.

The Executive Order also seeks to expand and diversify the workforce in biotechnology and biomanufacturing. In particular, Section 7 of the Order sets a deadline of 200 days for a plan to be developed for the coordination and use of Federal education and training programs to create expanded opportunities for all Americans in the field. The Order emphasized the need to provide training and education opportunities in the industry at all levels, from technical schools to expanded career pathways into existing degree programs in the field. The Order also notes that the plan should specifically include a discussion of Historically Black Colleges and Universities, Tribal Colleges and Universities and Minority Serving Institutions with respect to expanding the workforce in this field. The Executive Order requires that a report be submitted within two years to identify the measures taken and resources allocated to enhance biotechnology and biomanufacturing workforce development according to the plan.

Section 8 of the Order acknowledges that the current regulatory system for biotechnology products may be difficult for businesses to navigate. Therefore, the current system may cause delays of certain products making it to market. The Executive Order sets deadlines for the identification of and plan for addressing with reform any areas of ambiguity, gaps, or uncertainties in the current regulatory system.

Section 4 establishes a Data for the Bioeconomy Initiative to obtain data with respect to the current state of the U.S. bioeconomy. Sections 10 and 11 set forth goals for measuring the bioeconomy and identifying and assessing foreign threats to the U.S. bioeconomy.

Takeaway – The sections of Executive Order 14081 described briefly here are only a few aspects of the extensive plan set forth in the Executive Order. President Biden continues the work of previous administrations and identifies lofty goals for expanding and improving biotechnology and biomanufacturing research and the bioeconomy in the U.S. The steps detailed in the Executive Order to meet these goals will take time but could have meaningful social and economic impact moving forward.