On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” The work undertaken pursuant to the Executive Order is referred to as the National Biotechnology and Biomanufacturing Initiative (or, NBBI).
In order to achieve the objectives of the Executive Order, the Biden Administration plans to, amongst other action items, “(b) foster a biological data ecosystem that advances biotechnology and biomanufacturing innovation, while adhering to principles of security, privacy, and responsible conduct of research; (c) improve and expand domestic biomanufacturing production capacity and processes, while also increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice.”
With respect to fostering a biological data ecosystem, the Executive Order sets forth a Data for the Bioeconomy Initiative (Data Initiative) to “ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the United States bioeconomy.” The Data Initiative requires that the heads of various relevant agencies:
(i) identif[y] the data types and sources, to include genomic and multiomic information, that are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D, along with any data gaps;
(ii) set forth a plan to fill any data gaps and make new and existing public data findable, accessible, interoperable, and reusable in ways that are equitable, standardized, secure, and transparent, and that are integrated with platforms that enable the use of advanced computing tools;
(iii) identif[y] — based on the data types and sources described in subsection (a)(i) of this section — security, privacy, and other risks (such as malicious misuses, manipulation, exfiltration, and deletion), and provides a data-protection plan to mitigate these risks; and
(iv) outline the Federal resources, legal authorities, and actions needed to support the Data Initiative and achieve the goals outlined in this subsection, with a timeline for action.
With respect to improving and expanding domestic biomanufacturing production capacity and processes, the Executive Order requires that the heads of various relevant agencies like the National Science Foundation (NSF) and Department of Commerce “identif[y] policy recommendations to expand domestic biomanufacturing …, with a focus on advancing equity, improving biomanufacturing processes, and connecting relevant infrastructure.” The Executive Order further requires, amongst other actions:
(i) the NSF … expand its existing Regional Innovation Engine program to advance emerging technologies, including biotechnology;
(ii) the Department of Commerce … address challenges in biomanufacturing supply chains and related biotechnology development infrastructure
The Fact Sheet accompanying the Executive Order described approximately $2 billion in funding to support the NBBI. This spending includes:
- The Department of Health and Human Services investing $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (APIs), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics.
- The NSF funding Regional Innovation Engines to support biotechnology and biomanufacturing topics such as manufacturing life-saving medicines.
- The U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge investing more than $200 million to strengthen America’s bioeconomy with investments to expand the bioeconomy by advancing regional biotechnology and biomanufacturing programs. The regional investments will aim to rebuild pharmaceutical supply chains to lower drug costs, enhance the production and distribution of regenerative tissues and organs, and develop a robust pipeline of biotech talent, expanding opportunities to underserved and historically excluded communities.
Further, the Fact Sheet notes that the FDA will push efforts to support advanced manufacturing through regulatory science, technical guidance and increased engagement with industry seeking to leverage these emerging technologies, all with the goal of increasing medical supply chain resilience and improving patient access to new medical products.
HHS Activities In conjunction with the NBBI, the HHS announced its plan in executing the NBBI. This includes supporting development of (a) FDA research programs for advanced biologics manufacturing technologies, (b) the Advanced Manufacturing Innovation Hub and the FDA Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals, (c) opportunities for drug, biologics and device manufacturers to engage with FDA, (d) harmonization of international standards for biologics and biomanufactured products, and (e) cell engineering capabilities and platforms.