A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.
The COVID-19 pandemic highlighted the fact that global healthcare needs may be best addressed by ensuring a thriving bioeconomy, a term used to describe economic activity derived from biotechnology and biomanufacturing. With the intention of enhancing the U.S. bioeconomy, President Biden announced on September 12 an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (the Executive Order).
Among other things, the Executive Order aims to bolster federal investment in key research and development areas of biotechnology and biomanufacturing, clarify and streamline the regulations, improve and expand domestic biomanufacturing production capacity and processes, and train and support a workforce that will advance the bioeconomy.
Importantly, the Executive Order contains a promise to clarify — and potentially simplify — regulatory pathways for genome-edited microorganisms used in fermentation and related manufacturing processes. Such efforts could ease the path to market for a range of innovative products that use synthetic biology or genome editing by streamlining the current applicable U.S. regulatory framework, the Coordinated Framework for Biotechnology (the Coordinated Framework).
The 1992 Coordinated Framework directs U.S. regulatory agencies to rely on existing statutory frameworks to regulate the products of biotechnology. This approach means that regulatory authority for biotech in the U.S. is currently distributed among multiple agencies, depending on the nature of the product. The result is often multiple overlapping, and evolving, regulatory requirements, making the appropriate route to market complex.
The Executive Order recognizes this challenge and calls for regulatory clarity and efficiency. It also nods to the increasing importance of genomics data in the bioeconomy, and promises support to ensure that such data is interoperable and available over the long term. The U.S. government seems determined to act fairly quickly, and developers and external stakeholders should monitor for opportunities to provide information, including identifying ambiguity, gaps, or uncertainties in the Coordinated Framework.
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