Innovations in plant and animal biotechnology offer tremendous opportunities for advancing public health. Promising new technologies that can edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity and food security. 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.
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. Today, we’re announcing our new Plant and Animal Biotechnology Innovation Action Plan. This new plan advances policy priorities that the FDA will pursue to clarify our science-and-risk-based approach for product developers; avoid unnecessary barriers to future innovation in plant and animal biotechnology; and advance safety and our public health mission.
Our Action Plan works to address questions we regularly receive from biotechnology stakeholders, including developers of these products and public health interest groups. This new plan identifies priorities in three important areas: 1) advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways; 2) strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology; and 3) increasing engagement with domestic and international partners on biotechnology issues.
Many of the priorities identified in our Action Plan are well underway. We will be seeking public input as appropriate, over the coming year, with the expectation of continuing implementation and making meaningful progress on the Action Plan’s commitments in the months and years ahead.
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.
As part of this effort, the agency intends to publish two guidance documents over the next year. These new guidances will provide more clarity on how the FDA is applying its regulatory oversight to evaluate new animal biotechnology products based on the risk profile of various products.
In addition, the FDA’s Center for Veterinary Medicine (CVM) intends to hold a public webinar on Dec. 3, during which we’ll discuss the science behind genome editing in animals, the promising uses of this technology in animals and the potential risks, and information about CVM’s flexible risk-based approach to the regulation of intentional genomic alterations to animals. CVM will also address some of the common misconceptions about the FDA’s regulation of these products. At this webinar, the 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.
We’re also piloting a new Veterinary Innovation Program (VIP) for developers of intentionally genetically altered (IGA) animals and animal cells, tissues and cell- or tissue-based products (ACTPs) that are seeking the FDA’s approval of a new animal drug application. The program will provide intensive assistance for developers of IGA animals or ACTPs that benefit human or animal health, animal well-being or food production. The goal of the VIP is to facilitate advancements in the development of innovative animal products by enhancing certainty in the regulatory p...
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