FDA Announces Plan to Advance Biotech Innovation

07 November 2018

BioPharm International

FDA announced a new plan to advance plant and animal biotechnology innovation, FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram said in an Oct. 30, 2018 statement. The agency’s Plant and Animal Biotechnology Innovation Action Plan explains how FDA will clarify its science-and-risk-based approach to product development and support innovation while advancing safety and its public health mission.

“New forms of biotechnology allow modification of living organisms, such as plants or animals, in order to produce a new product, such as a novel pharmaceutical, new food variety, or disease-resistant crop. These are just some of the new plant and animal-based biotechnology innovations that are opening up new opportunities to improve public health,” said Gottlieb and Abram in the statement. “At the FDA, we’re committed to fostering advances in this field while ensuring the safety of plant and animal biotechnology products used by consumers. The FDA is taking new steps to put in place modern regulation that fosters innovation in this emerging space.”

FDA said its action plan will address common questions from biotech developers and public health interest groups. Priority areas identified by the plan are applying modern, efficient and risk-based regulatory pathways; strengthening public outreach and communication; and increasing engagement with domestic and international partners. 

“As a first step, the FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them. This modern, flexible framework will advance the agency’s commitment to safety while promoting innovation in this space. Our shared goal is to help usher in new, beneficial, and safe products to consumers and animals as quickly and safely as possible,” said FDA in the statement.

The agency intends to publish two guidance documents over the next year that will provide more clarity. In addition, FDA’s Center for Veterinary Medicine (CVM) will hold a public webinar on Dec. 3, 2018 to discuss intentionally genetically altered (IGA) animals. At this webinar, FDA’s Center for Biologics Evaluation and Research will also provide information about genome editing used in producing human products, including those for use in xenotransplantation, and how these products will be regulated. 

FDA also plans to work with domestic and international partners to foster efficiency and regulatory cooperation and enhance regulatory science. “For example, we hope to engage in a dialogue about how transformative biotechnology tools, such as genome editing, may eventually be used to help address vector-borne diseases like the Zika virus,” said the commissioners in the statement. 

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