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 Committee’s 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:
- The Committee noted that unnecessarily complex regulatory oversight runs the risk of facilitating an “imitate not innovate” mentality and may not match the pace of innovation.
- It found that a carefully balanced, coordinated approach toward future biotechnology products that incorporates input from stakeholders will be required, given the significant pipeline of innovative biotechnology products likely to emerge over the next decade.
- The Committee encouraged enhanced connections between research in regulatory science and its use in biotechnology research and product development in order to accommodate the profusion of new biotechnology 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 relevant regulatory agencies should increase scientific capabilities, tools, expertise, and horizon-scanning in key areas of expected growth of biotechnology.
- Regulatory agencies should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex.
- Agencies, like the Department of Defense and the Department of Energy, that fund biotechnology research with the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory-science activities.
The Committee’s 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.
Arent Fox will continue to actively monitor these and other developments related to the regulation of current and future biotechnology products. If you would like more information on this or related matters, please contact Karen Carr, Stan Abramson, Brian Ronholm, or the Arent Fox attorney who regularly handles your matters.