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BIO Welcomes Announcement of FDA’s Plant and Animal Biotechnology Innovation Action Plan

Washington, D.C. (November 1, 2018) – The Biotechnology Innovation Organization (BIO) released the following statement regarding the U.S. Food and Drug Administration (FDA) Plant and Animal Biotechnology Innovation Action Plan:

“BIO’s members lead the way in generating innovative, beneficial solutions to some of society’s most pressing health, nutrition, and environmental challenges. As a cutting-edge industry, we have a long and productive working relationship with the FDA and other federal agencies in support of science- and risk-based regulatory approaches that drive innovation while strengthening public and environmental health.

 

“The FDA understands the value of biology-based tools that help it fulfill its mission to the American public. BIO applauds the FDA’s commitment, as part of its recently announced Action Plan, to invest agency time and energy in establishing a fresh approach to biotechnology regulation that empowers American ingenuity and spurs consumer access to health, nutrition, and environmental solutions.

“BIO is a key stakeholder with the FDA and looks forward to working with the Commissioner and his team. The priorities outlined in the Action Plan reflect many of the recommendations BIO promotes in ongoing dialogue with Administration officials and Congress, especially regarding the treatment of products improved through gene editing.

“As industry and academia outlined in public comments about gene editing to the FDA in 2017, it is essential that the American government establish a right-sized regulatory approach for gene editing that fosters innovation and access to beneficial products – for the sake of society at large and for our nation’s own economic and competitive success.”