On September 12, 2022, United States President Joseph Biden issued an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.
The Executive Order referenced lessons learned from the COVID-19 pandemic about the “vital role” that biotechnology and biomanufacturing played in “developing and producing life-saving diagnostics, therapeutics, and vaccines” to protect Americans and the world. The Executive Order set forth policy goals to use biotechnology in a variety of areas, including health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.
Specifically, the Executive Order directs various branches of the federal government to do the following:
- Invest in and coordinate research and development in biotechnology and biomanufacturing
- Foster a secure and ethical “biological data ecosystem”
- Improve upon and expand production capacity while accelerating translation of basic research to commercial products
- Increase biomass production and “climate smart” incentive for agriculture
- Clarify and streamline regulations and make biological risk management a “cornerstone” of biotechnology and biomanufacturing R&D
- Promote standards and establish metrics to inform policy, decision-making, and investment
- Develop approaches for risk and threat assessment in partnership with private industry
- Engage with other countries to enhance cooperation.
Within 180 days of the Executive Order, the Secretaries of Health and Human Services, Energy, Agriculture, Commerce, as well as the Director of the National Science Foundation, will each submit a report. Specifically, the Secretary of Health and Human Services will assess how to use biotechnology and biomanufacturing to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes; the Department of Energy report will assess how to use biotechnology, biomanufacturing, bioenergy, and biobased products to address the causes and adapt to/mitigate the impacts of climate change; the Department of Agriculture will review how to use biotechnology and biomanufacturing for food and agriculture innovation, increasing food quality and nutrition, increasing and protecting agricultural yields, protecting against plant and animal pests and diseases, and cultivating alternative food sources; the Department of Commerce will report on how to use biotechnology and biomanufacturing to strengthen the resilience of United States supply chains.
Within 90 days of the Executive Order, the Office of Management and Budget will be responsible for providing a budget the identifies the current levels of agency spending to help inform the development of the implementation plan. After receiving the reports, the Director of the Office of Science and Technology Policy, coordinating with appropriate agencies, will develop an implementation plan for the recommendations. The agencies and functionalities that are identified as being responsible for the implementing actions will need to report on the measures taken and resources allocated to enhance biotechnology and biomanufacturing within two years of the Executive Order.
Government Agency Response
Two days after the Executive Order was signed, the Department of Health and Human Services issued a press release covering some of the actions the department plans to take in response. According to the release, “HHS intends to leverage biotechnology and biomanufacturing in order to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes.” One action (among many) that HHS intends to take is to support the development of Food and Drug Administration (FDA) research programs for advanced manufacturing technologies, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), fueling multiple intramural and extramural research projects to build a knowledge base in support of regulatory assessment, as well as scientific standard, guidance, and policy development.
The Department of Defense also released a statement about its focus following the Executive Order, including the announcement of $1.2 billion in new investments in biomanufacturing (broken down into $1 billion in bioindustrial domestic manufacturing infrastructure and $200 million to support enhancements to biosecurity and cybersecurity).
BIO Response
Dr. Michelle McMurry-Heath, president & CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Executive Order, “BIO welcomes the Biden Administration’s directives to strengthen our domestic biotechnology and biomanufacturing industry. This Executive Order the president signed today acknowledges the ‘power of biotechnology’ and its benefits to the U.S. economy, work force and quality of life, as well its potential to boost food and agriculture innovation and address the climate crisis. 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.”
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