We, the undersigned, support the update of the Coordinated Framework for the Regulation of Biotechnology by the Office of Science and Technology Policy (OSTP) and the regulatory agencies within the FDA, EPA, and USDA. We agree with OSTP’s objectives to reduce barriers to future innovation with biotechnology and to increase communication about the regulatory system.
Scientists are using biotechnology to develop products that could address challenges of our changing environment and help meet the needs of our growing population. We need the regulatory agencies to clarify their roles and responsibilities so these products can be brought to market in a more efficient and predictable manner. Specifically, we need clarity on how emerging technologies such as gene editing are regulated, which agencies regulate which products, how the agencies coordinate their responsibilities, and what types of data are needed by each agency.
We would like the agencies to increase involvement of scientists in the long-term strategy to improve transparency, coordination, predictability, and efficiency of the regulatory system for biotechnology. Public comment sessions are a good start, but increased two-way communication between agencies and scientists is needed. More outreach to scientists through scientific meetings and other venues would help inform scientists on changes to the regulatory process and help the agencies stay abreast of emerging technologies.
Public confidence in biotechnology could be greatly improved if the regulatory agencies took a prominent role in communicating the rigor of the regulatory process and the safety of the tools used in biotechnology. Communication methods such as videos and infographics would be helpful in this regard.
In closing, we applaud the OSTP for initiating this review of the Coordinated Framework and for encouraging the agencies to develop long-term strategies to improve their regulation of biotechnology. We look forward to increased involvement between scientists and regulatory agencies, and to a regulatory system that ensures scientists are able to develop much needed products for our changing world.
