In a report released on March 9, 2017, a National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests that will arise in the face of the expansion. The Committee also noted that regulators should be prepared for a broad array of new types of biotechnology products.

The report by the Committee on Future Biotechnology Products and Opportunities to Enhance the Capabilities of the Biotechnology Regulatory System is part of a larger effort initiated in July 2015 by the White House Office of Science and Technology Policy to clarify the roles of the agencies with primary responsibility for regulating products of biotechnology, to develop a long-term strategy to ensure that the regulatory system is prepared for future biotechnology products, and to commission an expert analysis of the future landscape of biotechnology products. The goal of the work is to increase public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness.

The Committee was tasked with undertaking the external, independent analysis of the future landscape of biotechnology products. The Committees newly-issued report follows the release of policy documents by FDA and USDA and the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, issued by OSTP earlier this year.

The Committee was charged with answering the following horizon-scanning questions: 1) What will the likely future products of biotechnology be over the next 5 10 years? and 2) What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? The Committee spent several months gathering information from a number of sources, including hearing from 74 speakers over the course of three in-person meetings and eight webinars, and responses from a dozen federal agencies. The Committee also solicited statements and written comments from the public.

The Committee identified a number of broad themes regarding future opportunities for enhancing the biotechnology regulatory system to best accommodate these new products:

Based on these conclusions, the Committee outlined three overall recommendations to enhance the capabilities of the biotechnology regulatory system in order to prepare for future biotechnology products, focusing primarily on the science-readiness of the federal regulators tasked under the Coordinated Framework with assessing new products of biotechnology:

The Committees identification of themes and recommendations is timely, given that federal agencies like USDA and FDA are currently seeking stakeholder feedback on those agencies proposed approaches to regulating products of genome editing.

See the original post:
Future of Biotech: National Academies Committee Report Scans the Horizon - Lexology (registration)